Inspection Observations FY19 0

Number of 483 issued from the Sy
Inspections ending between 10/1/2018 an
*This table does not represent the complete

during the fiscal year as some 483's were ma
not available in this format. The sum of 483's
will be greater than the actual Total 483's issu
year since a 483 may include citations related
areas, and counted more than once, under ea
center.
** This is the Actual Total number of 483's issu

and that are represented in this spr
Number of 483 issued from the System*
Inspections ending between 10/1/2018 and 9/30/2019
Cite Program Area Name 483s Issued
Biologics 116
Bioresearch Monitoring 190
Devices 822
Drugs 779
Foods 2540
Human Tissue for Transplantation 109
Parts 1240 and 1250 47
Radiological Health 17
Veterinary Medicine 229
Sum Product Area 483s from System* 4849
Actual Total in System 483s** 4770
*This table does not represent the complete set of 483's issued
during the fiscal year as some 483's were manually prepared and
not available in this format. The sum of 483's for all Product Areas
will be greater than the actual Total 483's issued during the fiscal
year since a 483 may include citations related to multiple product
areas, and counted more than once, under each relevant product
center.
** This is the Actual Total number of 483's issued from this system,
and that are represented in this spreadsheet.
Citation Program Area Cite Id Reference Number
Biologics 76 21 CFR 606.100(b)
Biologics 9225 21 CFR 606.171
Biologics 154 21 CFR 606.160(a)(1)
Biologics 18093 21 CFR 630.10(g)(1)
Biologics 98 21 CFR 606.100(c)
Biologics 57 21 CFR 606.60(a)
Biologics 150 21 CFR 606.151(e)
Biologics 160 21 CFR 606.160(a)(1)
Biologics 12203 21 CFR 606.170(a)
Biologics 18038 21 CFR 606.100(b)

Biologics 18134 21 CFR 640.21(g)
Biologics 41 21 CFR 606.40(a)(1)
Biologics 18082 21 CFR 630.10(e)(2)
Biologics 158 21 CFR 606.160(e)(1)
Biologics 9086 21 CFR 600.14(a)(1)

Biologics 18089 21 CFR 630.10(f)(4)
Biologics 18092 21 CFR 630.10(f)(6)(ii)
Biologics 18118 21 CFR 630.30(b)(1)
Biologics 80 21 CFR 606.100(b)(1)
Biologics 93 21 CFR 606.100(b)(14)
Biologics 94 21 CFR 606.100(b)(15)
Biologics 161 21 CFR 606.160(a)(2)
Biologics 224 21 CFR 640.4(f)
Biologics 227 21 CFR 640.4(h)

Biologics 9238 21 CFR 630.40(b)(3)
Biologics 12202 21 CFR 606.170(a)
Biologics 15038 21 CFR 610.47(a)(3)
Biologics 15044 21 CFR 610.47(b)(3)
Biologics 15068 21 CFR 610.46(a)(2)

Biologics 15083 21 CFR 606.121(c)(4)(ii)
Biologics 18048 21 CFR 606.145(a)
Biologics 18053 21 CFR 606.145(d)
Biologics 18060 21 CFR 630.5(c)(1)(i)
Biologics 18068 21 CFR 630.5(d)
Biologics 18081 21 CFR 630.10(e)(1)
Biologics 18085 21 CFR 630.10(f)(3)
Biologics 18096 21 CFR 630.10(g)(2)(ii)
Biologics 18097 21 CFR 630.10(h)

Biologics 18107 21 CFR 630.15(b)(2)(iii)
Biologics 18111 21 CFR 630.15(b)(6)
Biologics 18114 21 CFR 630.30(a)(1)
Biologics 18115 21 CFR 630.30(a)(2)
Biologics 18116 21 CFR 630.30(a)(3)
Biologics 18119 21 CFR 630.30(b)(2)
Biologics 18133 21 CFR 640.21(f)

Short Description
Establish, maintain and follow manufacturing SOPs
Biological product deviation report
Concurrent documentation
Required records
Proof Of Identity
Thorough investigations
Maintain and clean equipment
Equipment observed, standardized, calibrated
Procedures to maintain records of emergency

transfusions
Person performing, test results, interpretation
Adverse Reaction- Reports of Investigations
Equipment calibration frequency
SOPs for investigations, records

Informed consent
Qualifications of responsible personnel
Provide space for examination
Record review prior to release
Donor Eligibility on day of donation
Additional Medical Assessment Factors
Clean & orderly
Donor deferral record - each location
Who must report - manufacturer
When to report
Supplemental results
One or more approved screening tests
Seed lots
Medical History Interview
Physical Assessment Determination - Pulse
Physical Assessment Determination - Skin Examination
Unsuitable donation - release
Following manufacturer's instructions
Donor criteria
QC procedures for supplies and reagents
Schedules and procedures for equipment & calibration
Determination of lot numbers and supplies
Dating periods for licensed biological products
Arm preparation
Storage temperatures after collection
General requirements - storage
Quality control
Liquid Plasma - storage requirements
Prevention of contamination
Aseptic method of collection, separation and return of

RBCs
Storage temperature for plasma for Injectable

products
Microbial contamination
Personnel capabilities
Equipment
Maintenance - concurrence
Maintenance - tracing
Blood & Blood Components
Results of testing
Notification
Donor Deferral
Donor Deferral - reentry
Adverse Reaction - Investigations
Lookback System [Collecting Establishment]
Notify Consignees [Collecting Establishment]
Notify Transfusion Recipients or MD of Record

[Consignee]
Lookback System [Collecting Establishment]_x000D_
Supplemental Test for HIV [Collecting Establishment]

Expiration date for pooled Source Plasma
Control risk of contamination
Infection in bloodstream
Responsible physician not on site - SP &

plasmapheresis
CPR certification
Form and manner of educational material
Medical Assessment Factors
Physical Assessment Determination - Hemoglobin or

Hematocrit
Donor's Acknowledgment - Exculpatory language
Ineligible Donor
Donor consent clear
RBC loss deferral
Donor deferral
Donor health
Donor medical history
Unsuitable donation - defer testing
Deferral due to rbc loss

Long Description
Written standard operating procedures including all steps to be followed in the [collection] [processing]
[compatibility testing] [storage] [distribution] of blood and blood components for [allogeneic transfusion]
[autologous transfusion] [further manufacturing purposes] were not always [established] [maintained]
[followed] [available to personnel in the areas where procedures were performed]. Specifically, ***
Failure to submit a biological product deviation report [within 45 days from the date you acquired
information suggesting that a reportable event occurred]. Specifically, ***
Records are not concurrently maintained with the performance of each significant step in the [collection]
[processing] [compatibility testing] [storage] [distribution] of each unit of blood and blood components
so that all steps can be clearly traced. Specifically, ***
Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control]
[general] records. Specifically, ***
Failure to obtain from the donor on the day of donation [proof of identity] [a postal address where the
donor may be contacted for 8 weeks after donation]. Specifically, ***
Failure to [perform a thorough investigation] [make a record of the conclusions and follow-up] of [an
unexplained discrepancy] [a failure of a lot or unit to meet any of its specifications].
Specifically,***_x000D_
_x000D_
Failure to [maintain] [locate] equipment used in the [collection] [processing] [compatibility testing]
[storage] [distribution] of blood and blood products [in a clean and orderly manner] [so as to facilitate
cleaning and maintenance]. Specifically, ***
Equipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood
and blood components is not [observed] [standardized] [calibrated] on a regularly scheduled basis as
prescribed in the SOP Manual. Specifically, ***
Records [including signature by the physician requesting the procedure] are not maintained of all
emergency transfusions [including complete documentation justifying the emergency action].
Specifically, ***
Records fail to [identify the person performing the work] [include dates of the various entries] [show test
results] [include interpretation of the results] [show the expiration date assigned to specific products]
[be as detailed as necessary] so as to provide a complete history of the work performed. Specifically, ***
Written reports of investigations of adverse reactions, including conclusions and follow up, are not
prepared and maintained. Specifically,
Equipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood
and blood components is not observed, standardized and calibrated with at least the frequency required.
Specifically, ***
Written standard operating procedures for all steps in [the investigation of product deviations under the
regulations] [recordkeeping related to current good manufacturing practice and other applicable
requirements and standards] were not [established] [maintained] [followed] [available to personnel in
the areas where procedures were performed]. Specifically, ***
Failure of the responsible physician to [obtain the informed consent of a plateletpheresis donor on the
first day of donation and at subsequent intervals of no longer than 1 year] [explain the risks and hazards
of the procedure to the donor] [explain the risks and hazards in a manner that the donor may give
consent and had a clear opportunity to refuse]. Specifically, ***
The personnel responsible for the [collection] [processing] [compatibility testing] [storage] [distribution]
of blood or blood components are not adequate in [number] [educational background] [training and
experience, including professional training as necessary] to assure competent performance of their
assigned functions, and to ensure that the final product has the safety, purity, potency, identity and
effectiveness it purports or is represented to possess. Specifically, ***
Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their
eligibility as blood donors. Specifically, ***_x000D_
All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit
of final product. Specifically, ***
Failure to determine donor eligibility on the day of donation and before collection. Specifically, ***
Medical history assessment failed to include factors that make the donor ineligible to donate when
donating could adversely affect the health of the donor or the safety, purity, or potency of the blood or
blood component could be affected adversely by [symptoms of a recent or current illness] [certain
medical treatments or medications] [travel to, or residence in, an area endemic for a transfusion-
transmitted infection] [exposure or possible exposure to an accidentally or intentionally released disease
or disease agent relating to a transfusion-transmitted infection] [pregnancy at the time of, or within 6
weeks prior to, donation] [whether, in the opinion of the interviewer, the donor appears to be under the
influence of any drug, alcohol or for any reason does not appear to be providing reliable answers to
medical history questions, or if the donor says that the purpose of donating is to obtain test results for a
relevant transfusion-transmitted infection] [the donor being a xenotransplantation product recipient].
Specifically, ***
Failure to maintain facilities in a clean and orderly manner. Specifically, ***
Failure to maintain at each location a record of all donors found to be ineligible or deferred at that
location so that products from such donors are not collected and/or released. Specifically, ***
Failure to submit [a] biological deviation [report] [reports]. Specifically, ***

Biological product deviations [were] [are] not reported within the 45 calendar day timeframe.
Specifically, ***
Failure to [attempt to obtain the results of further testing prior to notifying a donor of a deferral] [notify
a donor of the results of further testing]. Specifically, ***
Blood and blood components intended for transfusion or for use in manufacturing a product were not
tested for evidence of infection due to relevant transfusion-transmitted infections [using one or more
screening tests that the FDA has licensed, approved, or cleared for such use] [in accordance with the
manufacturer's instructions]. Specifically, ***
Failure to identify [primary] [subsequent] seed lots by [lot number] [date of preparation]. Specifically,
***
Failure to conduct a medical history interview prior to collection of blood or blood components [to
determine if the donor is in good health] [to identify risk factors closely associated with exposure to, or
clinical evidence of, a relevant transfusion-transmitted infection] [to determine if there are other
conditions that may adversely affect the health of the donor or the safety, purity, or potency or the blood
or blood components or any product manufactured from the blood or blood components]. Specifically,
***
Failure to determine that the donor was not in good health based on [an irregular pulse] [a pulse
measurement outside 50 and 100 beats per minute]. Specifically, ***
Failure to determine that the donor was in good health based on an absence of [punctures] [scars]
indicative of injected drugs of abuse on the [arms] [forearms]. Specifically, ***
Failure to prevent the release of unsuitable blood and blood components for [transfusion] [further
manufacturing]. Specifically, ***
Failure to use supplies and reagents in a manner consistent with instructions provided by the
manufacturer. Specifically, ***
The standard operating procedures failed to include written descriptions of criteria used to determine
donor eligibility. Specifically, ***_x000D_
The standard operating procedure fails to include a written description of the quality control procedures
for supplies and reagents employed in [blood collection] [processing] [pretransfusion testing].
Specifically, ***
The standard operating procedure fails to include a written description of schedules and procedures for
equipment maintenance and calibration. Specifically, ***
Appropriate records are not available to determine the lot numbers of [supplies] [reagents] used for
specific [lots] [units] of the final product. Specifically, ***
Failure to assign dating periods in accordance with 21 CFR 610.53 or as approved by CBER. Specifically,
***
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of
Whole Blood. Specifically, ***
After collection, blood is not [immediately stored at a temperature between 1 and 6 degrees Celsius]
[transported from the donor clinic to the processing laboratory in temporary storage to cool the blood
continuously toward a range between 1 and 6 degrees Celsius]. Specifically, ***
Failure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after
processing. Specifically, ***
Failure to test each month (of manufacture) four units prepared from different donors at the end of the
storage period for [platelet count] [pH of not less than 6.0 measured at the storage temperature of the
unit] [actual plasma volume]. Specifically, ***
Failure to store Liquid Plasma at a temperature of 1 to 6 degrees Celsius within [4 hours after filling the
final container] [the time frame specified in the directions for use of the processing system]. Specifically,
***
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of
blood. Specifically, ***
Failure to [collect blood] [separate plasma] [return cells to the donor] by aseptic methods in a [sterile
system] [vented system which protects the blood cells and plasma against contamination]. Specifically,
***
Failure to store plasma intended for manufacturing into injectable products at a temperature [not
warmer than -20 degrees Celsius] [appropriate for the intended use of the final product as included in
the Source Plasma license application]. Specifically, ***
All processing steps were not conducted in a manner to minimize the risk of contamination. Specifically,
***
Failure to assure that personnel have [capabilities commensurate with] [the necessary training in]
[necessary experience in] [a thorough understanding of] the operations which they perform. Specifically,
***
There is no assurance that equipment is [adequately sterilized] [properly cleaned] [inspected for
cleanliness] [suitable for use]. Specifically, ***
Records are not made [concurrently with the performance] of each step in the [manufacture]
[distribution] of products. Specifically, ***
Records are not maintained in a manner which allows steps in the [manufacture] [distribution] of
product to be traced. Specifically, ***
Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 ?C or colder]
[Cryoprecipitated AHF at -18 ?C or colder] [Liquid Plasma at 1 to 10 ?C] [Plasma at -18 ?C or colder]
[Platelets as close as possible to the labeled range] [Platelet Rich Plasma as close as possible to the
labeled range] [Red Blood Cells between 1 and 10 ?C] [Red Blood Cells, Frozen at -65 ?C or colder]
[Source Plasma at -5 ?C or colder] [Source Plasma Liquid at 10 ?C or colder] [Whole Blood as required].
Specifically, ***
Failure to notify the donor of the results of [tests for evidence of infection with relevant transfusion-
transmitted infections that were a basis for deferral] [further testing]. Specifically, ***
Failure to make reasonable attempts to notify a donor who has been [deferred based on the results of
tests for evidence of infection with a relevant transfusion-transmitted infection(s)] [deferred because
their donated platelets have been determined to be contaminated with an organism likely to be
associated with a bacterial infection that is endogenous to the bloodstream of the donor] [determined
not be to eligible as a donor based on eligibility criteria]. Specifically, ***
Failure to defer a donor who tested reactive by a screening test for evidence of infection due to a
relevant transfusion-transmitted infection from future donations of human blood and blood
components. Specifically, ***
The method or process used to requalify deferred donors was not found acceptable for such purposes by
FDA. Specifically, ***
A thorough investigation of each reported adverse reaction was not made. Specifically,
Failure to [establish] [maintain] [follow] an appropriate system for HCV "lookback." Specifically, ***
Failure to notify consignees of [the results of further testing for HCV] [the results of the reactive
screening test] within 45 calendar days after the donor tests reactive for evidence of HCV infection under
the regulations. Specifically, ***
Failure to notify [transfusion recipients who received previous collections of blood and blood
components at increased risk of transmitting HCV infection] [the physician of record for transfusion
recipients who received previous collections of blood and blood components at increased risk of
transmitting HCV infection] [the legal representative or relative of transfusion recipients who received
previous collections of blood and blood components at increased risk of transmitting HCV infection] of
the need for recipient HCV testing and counseling. Specifically, ***
Failure to [establish] [maintain] [follow] an appropriate system for HIV "lookback." Specifically, ***
Failure to perform further testing for HIV on the reactive donation, as required by the regulations.
Specifically, ***
The container label for pooled Source Plasma intended for manufacturing into noninjectable products
fails to include the expiration date determined from the oldest unit in the pool. The pooling records
must show the collection date for each unit in the pool. Specifically, ***
Failure to assure that the risk of bacterial contamination of platelets was adequately controlled by using
[FDA approved or cleared devices] [adequate and appropriate methods found acceptable by FDA].
Specifically, ***
Failure of the responsible physician to determine whether an organism identified in a bacterially

contaminated platelet is likely to be associated with a bacterial infection that is endogenous to the
bloodstream of the donor. Specifically, ***
The responsible physician or physician substitute was not on the premises at the collection site when the
[determination and documentation of the eligibility of a donor] [collection of blood and blood
components] [return of red blood cells during apheresis] [collection of Source Plasma from an ineligible
donor in an approved collection program] [collection of a blood sample for testing for syphilis, total
protein, and serum protein electrophoresis] was delegated to the physician substitute or other trained
person. Specifically, ***
Failure to assure that an individual who is currently certified in cardiopulmonary resuscitation is located
on the premises whenever collections of blood or blood components are performed. Specifically, ***
Failure to present educational material to the donor [in an appropriate form] [in a manner designed to
be understood by the donor]. Specifically, ***
Medical history assessment failed to include factors that make the donor ineligible to donate because of
an increased risk for, or evidence of, a relevant transfusion-transmitted infection such as [behaviors
associated with a relevant transfusion-transmitted infection] [receipt of blood or blood components or
other medical treatments and procedures associated with possible exposure to a relevant transfusion-
transmitted infection] [signs and/or symptoms of a relevant transfusion-transmitted infection]
[institutionalization for 72 hours or more consecutively in the past 12 months in a correctional
institution] [intimate contact with risk for a relevant transfusion-transmitted infection] [nonsterile
percutaneous inoculation]. Specifically, ***
Failure to determine that the donor was in good health based on a determination of the donor's
[hemoglobin level] [hematocrit value] by using a sample of blood obtained by [fingerstick]
[venipuncture] [a method that provides equivalent results to a fingerstick or venipuncture]. Specifically,
***
The donor acknowledgment [contained exculpatory language through which the donor is made to waive
or appear to waive any of the donor's legal rights] [did not address the donor's review of educational
material regarding relevant transfusion-transmitted infections] [did not address the donor's agreement
to not donate if the donation could result in a potential risk to recipients] [did not address that a sample
of the donor's blood will be tested for specified relevant transfusion-transmitted infections] [did not
address donations determined to be not suitable] [did not address the deferral of donors from donation]
[did not address the donor's record with identification of the donor as ineligible to donate] [did not
address donor notification of the basis for deferral and the period of deferral] [did not address donors
receipt and review of information regarding risks and hazards of the specific donation procedure] [did
not address an opportunity for the donor to ask question and withdraw from the donation procedure].
Specifically, ***
Blood or blood components were collected from a donor [found to be ineligible prior to collection based
on the regulations] [found to be deferred under the regulations prior to collection]. Specifically, ***
Failure of the responsible physician to explain the risks and hazards of the plasmapheresis procedure in a
manner that the donor [gave their consent] [had a clear opportunity to refuse the procedure].
Specifically, ***
Failure to defer a donor from donating plasma by plasmapheresis after the donor [donated Whole Blood]
[donated a single unit of Red Blood Cells by apheresis] [donated two units of Red Blood Cells during a
single apheresis procedure] [experienced a cumulative blood loss in an 8 week period that could
adversely affect donor health]. Specifically, ***
Failure to determine the suitability of a donation of blood and blood components based on whether the
donor was currently deferred from donation. Specifically, ***
Failure to determine the suitability of a donation of blood and blood components based on whether [the
donor was in good health] [procedures were followed to ensure that the donation would not adversely
affect the health of the donor]. Specifically, ***
Failure to determine the suitability of a donation of blood and blood components based on whether the
donor was free from [risk factors for, or evidence of, relevant transfusion-transmitted infections] [factors
that make the donor ineligible to donate]. Specifically, ***
Failure to properly defer the donor of blood and blood components when the donation was unsuitable
based on the results of [the donor eligibility process] [testing for evidence of infection with relevant
transfusion-transmitted infection]. Specifically, ***
Failure to defer a plateletpheresis donor after the donor experienced a red blood cell loss. Specifically,
***
Frequency
32
16
15
15
12
11
4
4
2
2
1
1
1
1
1
1
1
Bioresearch Monitoring 7560 21 CFR 312.60
Bioresearch Monitoring 7530 21 CFR 312.62(b)
Bioresearch Monitoring 7526 21 CFR 312.62(a)
Bioresearch Monitoring 7318 21 CFR 56.115(a)(2)

Bioresearch Monitoring 3920 21 CFR 58.33(c)
Bioresearch Monitoring 3923 21 CFR 58.33(f)
Bioresearch Monitoring 7320 21 CFR 56.109(e)
Bioresearch Monitoring 3926 21 CFR 58.35(b)(1)


Bioresearch Monitoring 3977 21 CFR 58.90(g)
Bioresearch Monitoring 3988 21 CFR 58.105(d)

Bioresearch Monitoring 7369 21 CFR 56.109(h)

Bioresearch Monitoring 7411 21 CFR 312.53(c)(1)
Bioresearch Monitoring 7456 21 CFR 312.57(d)

Short Description
FD-1572, protocol compliance
Case history records- inadequate or inadequate
Accountability records
General responsibilities of sponsors
Minutes of IRB meetings
Informed consent
Safety reports
Changes in research
Consent form not approved/signed/dated
List of members
Unanticipated problems
Initial and continuing review
Initial and continuing reviews
Consent not obtained, exceptions do not apply
Retention of records
Confidentiality, FDA inspection of records
Study director: all data recorded and verified
Study director: unforeseen circumstances
Study director: transfer of data to archives
Reagents: labeling
Conduct: in accordance with protocol
Members present for review
Continuing review
IRB approvals/disapprovals - general
Reasonably foreseeable risks or discomforts
Record retention
Failure to submit an IND
Circumstances of obtaining consent
Notifying contractor of GLP status
QAU: maintain a master schedule

SOPs: required
Test article: storage container labeling
Protocol: date and signature
Final report: circumstances affecting data qual.,

integrity
One scientific and one non-scientific member
Method to keep members advised
Records of receipt, shipment, disposition
Monitoring investigations
Ensuring compliance with plan and protocol
Notification of FDA of termination of investigator
Reporting
IRB registration information
Personnel: education, training, experience
Personnel: summary of training, job description
Management: personnel understand their functions
Study director: follow GLP regulations
QAU: monitor facilities, etc.

QAU: inspect study at adequate intervals
QAU: authorize deviations from protocols or SOPs
QAU: review final study report
QAU: SOPs and required records
Facility: areas for disease diagnosis, treatment, &

control
Equipment: maintenance records
SOPs: availability
Animal care: cage and equipment cleaning
Animal care: analysis of feed and water
Test article: reserve sample retention
Test article: handling
Mixtures: uniformity and concentration
Protocol: dosage
Protocol: tests, analyses, and measurements
Protocol: approval of changes
Conduct: identification of test specimens
Conduct: recording in ink
Conduct: identification of individual inputting data

Final report: names of those involved
Archives: data, documentation, specimens
Archives: orderly storage, expedient retrieval
Archives: individual responsible
Procedures, identification of those which were

experimental
Prompt reporting of noncompliance
Reporting of suspension/termination
Factors required for approval
Children as subjects
Copy of consent form not provided
Statement of research, purpose, duration of

participation
Participation; refusal and discontinuance

Investigator selection
Investigator statement (FDA 1572)
Investigator non-compliance
Bioequivalence samples
Records of unused drug disposition
Unused drug disposition (investigator)
Unauthorized recipients (investigator)
Record retention requirement
Required label statement
Research not eligible for expedited review
Understandable language
Changes in contact or chairperson information
Decison to disband IRB

Long Description
An investigation was not conducted in accordance with the [signed statement of investigator]
[investigational plan]. Specifically, ***
Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and
data pertinent to the investigation] [informed consent]. Specifically, ***_x000D_
Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by
subjects]. Specifically, ***_x000D_
Failure to [select qualified investigators] [provide investigators with the information needed to conduct
the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in
accordance with the protocol and/or investigational plan] [ensure that FDA and all investigators are
promptly informed of significant new adverse effects or risks]. Specifically, ***
Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance
at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members
voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written
summary of the discussion of controverted issues and their resolution]. Specifically, ***
Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to
[drug administration] [conducting study-related tests]. Specifically, ***
Failure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused
by, or probably caused by, an investigational drug. Specifically, ***
Not all changes in research activity were approved by an Institutional Review Board prior to
implementation. Specifically, ***
Informed consent was not properly documented in that the written informed consent used in the study
[was not approved by the IRB] [was not signed by the subject or the subject's legally authorized
representative at the time of consent ] [was not dated by the subject or the subject's legally authorized
representative at the time of consent]. Specifically, ***
A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned
degrees] [representative capacity] [indications of experience sufficient to describe each member's chief
anticipated contribution to IRB deliberations] [any employment or other relationship between each
member and the institution]. Specifically, ***
Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or
others. Specifically, ***_x000D_
_x000D_
Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the
initial and continuing review and approval of a clinical study. Specifically, ***
The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of
research. Specifically, ***
Legally effective informed consent was not obtained from a subject or the subject's legally authorized
representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.
Specifically, ***
Records required by 21 CFR 56 have not been maintained for three years following completion of the
There was no statement in the informed consent document that [described the extent, if any, to which
confidentiality of records identifying the subject would be maintained] [noted the possibility that the
Food and Drug Administration might inspect the records]. Specifically, ***
The study director failed to assure that all experimental data, including observations of unanticipated
responses of the test system, were accurately recorded and verified. Specifically, ***
The study director failed to assure that unforeseen circumstances that might affect the quality and
integrity of the nonclinical laboratory study were noted when they occurred and corrective action was
taken and documented. Specifically, ***
The study director failed to assure that all raw data, documentation, protocols, specimens, and final
reports were transferred to the archives during or at the close of the study. Specifically, ***
Not all reagents and solutions in the laboratory areas are labeled to indicate identity, titer or
concentration, storage requirements, and expiration date. Specifically, ***
Not all nonclinical laboratory studies were conducted in _x000D_
accordance with the protocol. Specifically, ***_x000D_
For other than expedited reviews, the IRB does not always review proposed research at convened
meetings at which a majority of the members of the IRB are present, including at least one member
whose primary concerns are in nonscientific areas. Specifically, ***
The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk]
[of not less than once per year]. Specifically, ***
The IRB has not promptly notified in writing [the investigator] [the institution] when the IRB has
[approved] [disapproved] [required modifications to secure IRB approval of] proposed research activity.
Specifically, ***
The informed consent document lacked a description of reasonably foreseeable risks or discomforts to
the subject. Specifically, ***
Investigational records were not retained for a period of two years following [approval of a drug's
marketing application] [discontinuance of the investigation and notification of FDA]. Specifically,
***_x000D_
The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an
investigational new drug. Specifically,***
The general requirements for informed consent were not met in that [you] [the investigator] did not seek
consent under circumstances that [provided the prospective subject or the subject's representative
sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or
undue influence]. Specifically, ***
Not all consulting laboratories, contractors, or grantees were notified that the study must be conducted
in compliance with FDA GLP regulations. Specifically, ***
The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all
required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***
Standard operating procedures have not been established for [animal room preparation] [animal care]
[receipt, identification, storage, handling, mixing, and method of sampling of the test and control
articles] [test system observations] [laboratory tests] [handling of animals found moribund or dead
during study] [necropsy of animals or postmortem examination of animals] [collection and identification
of specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of
equipment] [transfer, proper placement, and identification of animals]. Specifically, ***
Not all storage containers for a test or control article were labeled by name, chemical abstract number or
code number, batch number, expiration date, if any, and, where appropriate, storage conditions
necessary to maintain the identity, strength, purity, and composition of the test or control article.
Specifically, ***
Not all protocols contained the date of approval of the protocol by the sponsor and the dated signature
of the study director. Specifically, ***
The final study report did not include a description of all circumstances that may have affected the
quality or integrity of the data. Specifically, ***
The IRB does not include [at least one member whose primary concerns are in the scientific area] [at
least one member whose primary concerns are in nonscientific areas]. Specifically, ***
The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for
keeping members advised of research proposals which have been approved under the procedure.
Specifically, ***
Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an
investigational drug. Specifically, ***
Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***
Failure to ensure that an investigation was conducted in accordance with the general investigational plan
and protocols as specified in the IND. Specifically, ***
Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.
Specifically, ***
The IRB's [suspension] [termination of approval] for research was not reported [promptly] to [the
investigator] [appropriate institutional officials] [the Food and Drug Administration]. Specifically, ***
Registration information does not include the IRB [name] [mailing address] [street address different from
the mailing address] [phone number] [facsimilie number] [electronic mail address]. Specifically, **
Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical
laboratory study have education, training, and experience, or combination thereof, to enable that
individual to perform assigned functions. Specifically, ***
The testing facility failed to maintain a current summary of training and experience and job description
for each individual engaged in or supervising the conduct of a nonclinical laboratory study. Specifically,
***
Testing facility management failed to assure that all personnel clearly understood the functions they
were to perform. Specifically, ***
The study director failed to assure that all applicable GLP regulations were followed. Specifically, ***
The quality assurance unit did not monitor each study to assure management that the facilities,
equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP
regulations. Specifically, ***
The quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to
assure the integrity of the study and maintain written and properly signed records of each periodic
inspection. Specifically, ***
The quality assurance unit failed to determine whether any deviations from approved protocols or
standard operating procedures had been made with proper authorization and documentation.
Specifically, ***
The quality assurance unit failed to review the final study report to assure that such report accurately
described the methods and standard operating procedures, and that the reported results accurately
reflected the raw data of the study. Specifically, ***
The quality assurance unit failed to maintain and make available for inspection required records
regarding its responsibilities and procedures and the method of indexing such records. Specifically, ***
The testing facility does not provide separate areas, as appropriate, for the diagnosis, treatment, and
control of laboratory animal diseases. Specifically, ***
Adequate written records are not maintained of all equipment inspection, maintenance, testing,
calibrating and/or standardizing operations. Specifically, ***
Not all laboratory areas have immediately available laboratory manuals and standard operating
procedures relative to the laboratory procedures being performed. Specifically, ***
Not all animal cages, racks and accessory equipment were cleaned and sanitized at appropriate
intervals. Specifically, ***
Not all animal feed and water were analyzed periodically to ensure that expected contaminants were not
present at levels above those specified in the protocol. Specifically, ***
Not all reserve samples from each batch of test and control articles for studies of more than 4 weeks'
duration were retained for the required period of time. Specifically, ***
Procedures have not been established for the handling of the test and control articles to ensure that
[there is proper storage] [distribution is made in a manner designed to preclude the possibility of
contamination, deterioration, or damage] [proper identification is maintained throughout the
distribution process] [the receipt and distribution of each batch is documented including the date and
quantity of each batch distributed or returned]. Specifically, ***
Not all test or control articles mixed with a carrier were tested by appropriate analytical methods to
determine [the uniformity of the mixture] [periodically, the concentration of the test or control article in
the mixture]. Specifically, ***
Not all protocols contained each dosage level of the test or control article to be administered and the
method and frequency of administration. Specifically, ***
Not all protocols contained the type and frequency of tests, analyses, and measurements to be made.
Specifically, ***
Not all changes in, or revisions of, an approved protocol and the reasons therefore were documented,
signed by the study director, dated, and maintained with the protocol. Specifically, ***
Not all specimens were identified by test system, study, nature, and date of collection. This information
was not located on the specimen container or did not accompany the specimen in a manner that
precluded error in the recording and storage of data. Specifically, ***
Data generated without the use of an automated data collection system were not recorded directly,
promptly, and legibly in ink. Specifically, ***
In automated data collection systems, the individual responsible for direct data input was not identified
at the time of data input. Specifically, ***
The final study report did not include [the name of the study director] [the names of other scientists or
professionals] [the names of all supervisory personnel] involved in the study. Specifically, ***
Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens
obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids)]
generated as a result of a nonclinical laboratory study were retained. Specifically, ***
Archives failed to provide for orderly storage and expedient retrieval of all raw data, documentation,
protocols, specimens, and interim and final reports. Specifically, ***
An individual was not identified as responsible for the archives. Specifically, ***
The informed consent document did not contain [a description of the procedures to be followed]
[identification of any procedures which were experimental]. Specifically, ***
The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB]
[appropriate institutional officials] [the FDA] of any instance of serious or continuing noncompliance
with these regulations or the requirements or determinations of the IRB. Specifically, ***
The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB]
[appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval .
Specifically, ***
The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1)
an intervention or procedure that held out the prospect of direct benefit for the individual subjects,
and/or 2) by a monitoring procedure which was likely to contribute to the individual subjects' well-being.
However, the IRB did not [find] [document] that [the risk was justified by the anticipated benefit to the
subjects] [the relation of the anticipated benefit to the risk was at least as favorable to the subjects as
that presented by available alternative approaches] [adequate provisions had been made for soliciting
the assent of the children and the permission of their parents or guardians, as set forth in 21 CFR 50.55].
Specifically, ***
The IRB did not determine [at the time of initial review] [at the time of continuing review for an on-going
study which was started on/before April 30, 2001] that a study was in compliance with 21 CFR Part 50
Subpart D, "Additional Safeguards for Children in Clinical Investigations." Specifically, ***
A copy of the written consent form which had been approved by the IRB and signed and dated by the
subject or the subject's legally authorized representative, was not provided to the subject or the
subject's legally authorized representative at the time of consent. Specifically, ***
The informed consent document did not contain [a statement that the study involved research] [an
explanation of the purposes of the research, and the expected duration of the subject's participation].
Specifically, ***_x000D_
_x000D_
The informed consent document did not contain a statement that [participation was voluntary] [refusal
to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled]
[the subject might discontinue participation at any time without penalty or loss of benefits to which the
subject was otherwise entitled]. Specifically, ***
Investigators who were not qualified by training and experience as appropriate experts were selected to
investigate a drug. Specifically, ***
Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an
investigator to participate in an investigation. Specifically, ***
An investigator who did not comply with [the signed agreement] [the general investigational plan]
[applicable regulatory requirements] was not [promptly brought into compliance] [terminated].
Specifically, ***
Samples of the [test article] [reference standard] used in a [bioavailability] [bioequivalence] study were
not [retained] [released to FDA upon request as required by 21 CFR Part 320.38]. Specifically, ***
Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance
with 21 CFR Part 312.57. Specifically, ***
Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance
with sponsor instructions]. Specifically, *** _x000D_
A study drug was [administered to subjects] [provided to persons] not under the investigator's personal
supervision or under the supervision of a subinvestigator responsible to the investigator. Specifically,
***_x000D_
Records and reports were not retained for two years after [marketing application approval]
[discontinuance of the investigation and notification of FDA]. Specifically***
The immediate package of the investigational new drug does not bear a label with the statement
"Caution: New Drug- Limited by Federal (or United States) law to investigational use
The IRB used an expedited review procedure for research which did not appear in an FDA list of
categories eligible for expedited review, and which had not previously been approved by the IRB [within
one year]. Specifically, ***
The general requirements for informed consent were not met in that the information given was not in
language understandable to the subject or the subject's representative. Specifically, ***
The IRB did not revise its registration information with respect to changes in [the contact person] [the
chairperson] within 90 days of the change. Specifically, ***
The IRB did not report its decision to disband within 30 days of permanent cessation of the review of
Frequency
119
60
16
14
11
4
4
2
2
1
1
1
1
1
1
1
Devices 3130 21 CFR 820.100(a)
Devices 14713 21 CFR 820.198(a)
Devices 479 21 CFR 820.50
Devices 546 21 CFR 820.75(a)
Devices 3282 21 CFR 820.90(a)
Devices 2327 21 CFR 820.22
Devices 3696 21 CFR 820.100(b)
Devices 2371 21 CFR 820.30(a)
Devices 3103 21 CFR 820.30(i)
Devices 14722 21 CFR 820.40
Devices 3233 21 CFR 820.72(a)
Devices 3120 21 CFR 820.80(a)
Devices 3125 21 CFR 820.80(d)
Devices 3160 21 CFR 820.184
Devices 3331 21 CFR 820.181
Devices 3666 21 CFR 820.20(c)
Devices 14712 21 CFR 820.184
Devices 3159 21 CFR 820.184
Devices 3680 21 CFR 820.70(a)
Devices 3121 21 CFR 820.80(b)
Devices 3678 21 CFR 820.30(g)
Devices 2350 21 CFR 820.25(b)
Devices 3117 21 CFR 820.70(i)

Devices 3101 21 CFR 820.30(g)
Devices 3172 21 CFR 820.198(c)
Devices 3168 21 CFR 820.198(a)
Devices 541 21 CFR 820.70(c)
Devices 3104 21 CFR 820.30(j)

Devices 3837 21 CFR 820.25(b)
Devices 3118 21 CFR 820.75(a)
Devices 3127 21 CFR 820.80(e)
Devices 732 21 CFR 803.50(a)(2)
Devices 731 21 CFR 803.50(a)(1)
Devices 3119 21 CFR 820.75(b)
Devices 3132 21 CFR 820.120
Devices 3226 21 CFR 820.70(g)(1)
Devices 3375 21 CFR 820.198(e)

Devices 3415 21 CFR 820.22
Devices 3285 21 CFR 820.90(b)(2)
Devices 3426 21 CFR 820.50(a)(1)
Devices 3669 21 CFR 820.20(c)
Devices 2604 21 CFR 820.30(e)
Devices 14720 21 CFR 820.50(a)(3)
Devices 2650 21 CFR 820.30(f)
Devices 3128 21 CFR 820.90(a)

Devices 4059 21 CFR 820.22
Devices 21425 21 CFR 820.184(f)
Devices 2328 21 CFR 820.22
Devices 3286 21 CFR 820.90(b)(1)
Devices 486 21 CFR 820.50(a)
Devices 537 21 CFR 820.70(a)
Devices 3427 21 CFR 820.50(a)(2)
Devices 539 21 CFR 820.70(b)
Devices 631 21 CFR 803.17(a)(1)
Devices 3262 21 CFR 820.250(a)
Devices 3263 21 CFR 820.250(b)
Devices 3686 21 CFR 820.90(b)(2)
Devices 14714 21 CFR 820.30(c)

Devices 2302 21 CFR 820.20(e)
Devices 3102 21 CFR 820.30(h)
Devices 3235 21 CFR 820.72(a)
Devices 419 21 CFR 820.20(b)
Devices 454 21 CFR 820.40(a)
Devices 2974 21 CFR 812.110(b)
Devices 3192 21 CFR 820.30(g)
Devices 3207 21 CFR 820.50(b)
Devices 3676 21 CFR 820.30(f)

Devices 2630 21 CFR 820.30(e)
Devices 3170 21 CFR 820.198(b)
Devices 3425 21 CFR 820.50(a)(1)
Devices 4212 21 CFR 806.20(b)(4)
Devices 14716 21 CFR 820.30(f)
Devices 3123 21 CFR 820.80(c)
Devices 3345 21 CFR 820.200(a)
Devices 14718 21 CFR 820.30(g)
Devices 2928 21 CFR 812.40
Devices 3201 21 CFR 820.40(a)
Devices 3266 21 CFR 820.86
Devices 3433 21 CFR 820.75(c)
Devices 2269 21 CFR 820.20(a)
Devices 2557 21 CFR 820.30(c)
Devices 3108 21 CFR 820.70(e)
Devices 3147 21 CFR 820.170(a)
Devices 3199 21 CFR 820.40(a)
Devices 3677 21 CFR 820.30(g)
Devices 14710 21 CFR 820.150
Devices 14715 21 CFR 820.30(d)
Devices 14717 21 CFR 820.30(g)

Devices 632 21 CFR 803.17(a)(2)
Devices 633 21 CFR 803.17(a)(3)
Devices 3190 21 CFR 820.30(g)
Devices 3191 21 CFR 820.30(g)
Devices 3203 21 CFR 820.40(b)

Devices 3674 21 CFR 820.30(d)
Devices 635 21 CFR 803.17(b)(1)
Devices 2293 21 CFR 820.20(d)
Devices 2430 21 CFR 820.30(b)
Devices 3173 21 CFR 820.198(d)
Devices 3193 21 CFR 820.30(g)
Devices 3231 21 CFR 820.70(i)
Devices 3232 21 CFR 820.72(a)
Devices 3264 21 CFR 820.250(b)
Devices 3269 21 CFR 820.80(b)
Devices 3313 21 CFR 820.120(d)
Devices 3665 21 CFR 820.20(b)(3)
Devices 4070 21 CFR 820.30(g)
Devices 2968 21 CFR 812.100
Devices 3204 21 CFR 820.40(b)

Devices 3206 21 CFR 820.50(b)
Devices 3239 21 CFR 820.72(b)
Devices 3310 21 CFR 820.120(b)
Devices 3343 21 CFR 820.198(e)
Devices 3409 21 CFR 820.200(d)
Devices 3432 21 CFR 820.75(b)(2)
Devices 3434 21 CFR 820.75(c)
Devices 3668 21 CFR 820.20(c)
Devices 14505 21 CFR 812.140(a)(3)
Devices 14711 21 CFR 820.160(a)
Devices 2339 21 CFR 820.22
Devices 3149 21 CFR 820.180
Devices 3171 21 CFR 820.198(b)
Devices 3236 21 CFR 820.72(b)
Devices 3237 21 CFR 820.72(b)
Devices 3270 21 CFR 820.80(c)
Devices 3671 21 CFR 820.25(a)
Devices 3683 21 CFR 820.70(g)
Devices 3699 21 CFR 820.160(b)
Devices 4191 21 CFR 806.10(a)(1)
Devices 14721 21 CFR 820.70(g)(2)

Devices 21424 21 CFR 820.120(b)
Devices 793 21 CFR 803.53(a)
Devices 2431 21 CFR 820.30(b)
Devices 2949 21 CFR 812.46(a)
Devices 3115 21 CFR 820.70(h)
Devices 3139 21 CFR 820.140
Devices 3224 21 CFR 820.70(g)(2)
Devices 3323 21 CFR 820.170(b)
Devices 3682 21 CFR 820.70(d)
Devices 3841 21 CFR 820.90(b)(2)
Devices 4057 21 CFR 820.20(a)
Devices 4060 21 CFR 820.20(b)(3)(i)
Devices 4193 21 CFR 806.10(b)
Devices 7006 21 CFR 812.43(c)(5)
Devices 14511 21 CFR 812.2(b)
Devices 14719 21 CFR 820.30(h)

Devices 636 21 CFR 803.17(b)(2)
Devices 733 21 CFR 803.50(b)(1)
Devices 734 21 CFR 803.50(b)(2)
Devices 2602 21 CFR 820.30(d)
Devices 2940 21 CFR 812.43(c)(4)(i)
Devices 2941 21 CFR 812.43(c)(4)(ii)
Devices 2942 21 CFR 812.43(c)(4)(iii)
Devices 2944 21 CFR 812.43(d)
Devices 2969 21 CFR 812.100
Devices 2970 21 CFR 812.100
Devices 2984 21 CFR 812.140(a)(3)(i)
Devices 2985 21 CFR 812.140(a)(3)(ii)
Devices 2991 21 CFR 812.140(b)(1)
Devices 2992 21 CFR 812.140(b)(2)
Devices 3002 21 CFR 812.140(b)(5)
Devices 3021 21 CFR 812.150(a)(1)
Devices 3043 21 CFR 812.150(b)(2)
Devices 3113 21 CFR 820.70(g)
Devices 3155 21 CFR 820.181(a)

Devices 3175 21 CFR 820.186
Devices 3200 21 CFR 820.40(a)
Devices 3311 21 CFR 820.120(c)
Devices 3314 21 CFR 820.120(e)
Devices 3346 21 CFR 820.200(b)
Devices 3347 21 CFR 820.200(c)
Devices 3372 21 CFR 820.198(d)
Devices 3383 21 CFR 820.198(g)
Devices 3672 21 CFR 820.30(c)
Devices 4192 21 CFR 806.10(a)(2)
Devices 4211 21 CFR 806.20(b)(3)
Devices 4213 21 CFR 806.20(b)(5)
Devices 4436 21 CFR 803.40(a)
Devices 4437 21 CFR 803.40(b)
Devices 6801 21 CFR 807.21(a)
Devices 6849 21 CFR 812.5(a)
Devices 7013 21 CFR 812.110(d)
Devices 14508 21 CFR 812.140(a)(4)
Devices 14516 21 CFR 812.25(e)
Devices 14523 21 CFR 812.43(c)

Short Description
Lack of or inadequate procedures
Lack of or inadequate complaint procedures
Purchasing controls, Lack of or inadequate procedures
Lack of Written MDR Procedures
Lack of or inadequate process validation
Nonconforming product, Lack of or inadequate

procedures
Quality audits - Lack of or inadequate procedures
Documentation
Design control - no procedures
Design changes - Lack of or Inadequate Procedures
Procedures not adequately established or maintained
Calibration, Inspection, etc. Procedures Lack of or

Inadequ
Lack of or inadequate procedures - Acceptance
activities
Lack of or inadequate final acceptance procedures
Lack of or inadequate DHR procedures
DMR - not or inadequately maintained

Management review - Lack of or inadequate
procedures
DHR - not or inadequately maintained
DHR content
Process control procedures, Lack of or inadequate

procedures
Lack of or inadequate receiving acceptance procedures
Design Validation - Risk analysis not

performed/inadequate
Training - Lack of or inadequate procedures
Software validation for automated processes

Design validation- Lack of or inadequate procedures
Investigation of device failures
Complaints
Environmental control Lack of or inadequate
procedures
Design history file
Lack of procedures, or not maintained

Training records
Documentation
Documentation
Report of Malfunction
Report of Death or Serious Injury
Lack/Inad procedure-Monitoring/Control of Validated

Proces
Lack of or inadequate procedures for labeling
Maintenance schedule, Lack of or inadequate schedule
Records of complaint investigation

Quality Audit/Reaudit - conducted
Product rework procedures, Lack of or inadequate
procedures
Documented evaluation
Management review - defined interval, sufficient

frequency
Design review - Lack of or inadequate procedures
Acceptable supplier records, inadequate records
Design verification - Lack of or inadequate procedures
Nonconforming product control

Quality Audits - defined intervals
DHR - UDI not included
Quality audits - auditor independence
Procedures for product review,disposition lack

of/inadequate
Evaluation of suppliers, contractors, etc., requirements
Production processes
Supplier oversight
Production and Process Change Procedures, lack of or

Inad.
Lack of System for Event Evaluations
Statistical techniques - Lack of or inadequate

procedures
Sampling plans
Product rework documentation, DHR {see also 820.184}
Design input - Lack of or inadequate procedures

Quality System Procedures
Design transfer - Lack of or inadequate procedures
Equipment control activity documentation
Lack of or inadequate organizational structure
Document review, approval by designated individual
Investigator non-compliance with

agreement/plan/regulations
Design validation - user needs and intended uses
Supplier notification of changes
Design verification - documentation

Design review - documentation
Review and evaluation for investigation
Evaluation and Selection, Suppliers, Contractors, etc.
Justification for not reporting
Design verification - output does not meet input

requirement
Lack of or inadequate In-process acceptance
procedures
Servicing - Lack of or inadequate procedures
Design validation - Risk analysis
Sponsors' general responsibilities
Not approved or obsolete document retrieval
Acceptance status
Process changes - review, evaluation and revalidation
Quality policy and objectives
Design input - documentation
Contamination control, Lack of or inadequate

procedures
Lack of or inadequate instructions
Document review, approval documentation
Design validation - software validation not performed
Lack of or inadequate procedures for storage.
Design output - Lack of or inadequate procedures
Design validation - software validation documentation

Identification procedures, Lack of or inadequate
procedures
Lack of System for Determining MDR Events
Lack of System for Timely Submission of Reports
Design validation acceptance criteria
Design validation - production units
Document change records, maintained.

Design output - documentation
Info evaluated to determine if event was reportable
Quality plan
Design plans - Lack of or inadequate
Evaluation, timeliness, identification
Design validation - simulated testing
Documentation of software validation
Equipment suitability & capability
Sampling methods - Lack of or inadequate procedures
Incoming acceptance records, documentation
Records, DHR {see also 820.184(e)}
Management representative
Design validation - documentation
Investigator non-compliance with

agreement/plan/regulations
Change records, content

Approval, inadequate purchasing data
Remedial action - documentation
DHR documentation of label release {see also 820.184}
Maintained
Service reports
Documentation of validated process performance
Documentation - review in response to changes or

deviations
Management review dates
Investigator's subject records inadequate
Lack of or inadequate procedures for distribution
Quality Audit/Reaudit - documentation
Availability
Rationale documented for no investigation
Calibration procedures - content
Remedial action
Documentation
Personnel
Equipment Installation, Placement, Specified

Requirements
Distribution records
Report of risk to health
Periodic equipment inspections

Labeling inspection - UDI
Firm Did Not Submit 5 Day Report
Submission Within One Month
Design plans- updated
Sponsor securing investigator compliance
Use and removal, Lack of or inadequate procedures
Lack of or inadequate procedures for handling
Periodic equipment inspection lack of or inadequate

procedu
Installer records
Implementing Personnel Procedures, Health,

Cleanliness.
Product rework adverse effects {see also 820.184}
Management ensuring quality policy is understood
Management representative implementing the quality

system
Time to report - 10 days
No financial disclosure info in investigator agreement
Abbreviated requirements / non-significant risk study
Incorrect translation to production specifications
Traceability Lack of or inadequate {see also 820.120(e)}

Reports and information documentation
Reporting Information Reasonably Known
Providing Incomplete or Missing Information
Design output - review and approval
No investigation agreement statement of commitment
No supervision commitment in investigator agreement
No informed consent statement in investigator

agreement
Monitors not qualified
No investigator protection - subject rights, safety,

welfare
Investigator lack of informed consent
Investigator records of informed consent inadequate
Investigator records of relevant observations

inadequate
Sponsor correspondence records inadequate
Sponsor device shipment records inadequate
Sponsor records of adverse device effects & complaints
Investigator report of unanticipated adverse effects
Sponsor notification of IRB approval withdrawal
Equipment design and installation
DMR device specifications

QSR
Document locations, Dissemination, etc.
Storage
Control number {see also 820.65, 820.184(f)}
Analyzing service report
Service reports/MDRs/complaints
Records of MDR Investigation
Foreign complaint files
Design input - review and approval
Report of violation of the Act (see 803.52(e)(9))
Events
Records of communications
Report of death, injury by marketed device
Report of malfunction likely to cause death or injury
Initial registration
Label does not contain required information
Inadequate financial disclosure by investigator
Investigator record of protocol deviations inadequate
Sponsor's lack of written monitoring procedures
No investigator agreement
Long Description
Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not
been [adequately] established. Specifically,***
Procedures to ensure that all purchased or otherwise received product and services conform to specified
requirements have not been [adequately] established. Specifically, ***
Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, ***
A process whose results cannot be fully verified by subsequent inspection and test has not been
[adequately] validated according to established procedures. Specifically, ***
Procedures have not been [adequately] established to control product that does not conform to
specified requirements. Specifically, ***
Procedures for quality audits have not been [adequately] established. Specifically, ***
Corrective and preventive action activities and/or results have not been [adequately] documented.
Specifically, ***
Procedures for design control have not been established. Specifically,***
Procedures for design change have not been [adequately] established. Specifically,***
Document control procedures have not been adequately [established] [maintained]. Specifically,***
Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not
been [adequately] established. Specifically, ***
Procedures for acceptance activities have not been [adequately] established. Specifically,***
Procedures for finished device acceptance have not been [adequately] established. Specifically, ***
Procedures for device history records have not been [adequately] established. Specifically,***
A device master record has not been [adequately] maintained. Specifically, ***
Procedures for management review have not been [adequately] established. Specifically,***
A device history record has not been [adequately] maintained. Specifically, ***
The device history record does not demonstrate that the device was manufactured in accordance with
[the device master record] [21 CFR 820].
Process control procedures that describe any process controls necessary to ensure conformance to
specifications have not been [adequately] established. Specifically, ***
Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
Risk analysis [was not performed] [is inadequate] [is incomplete]. Specifically, ***
Procedures for training and identifying training needs have not been [adequately] established.
Specifically, ***
Software used as part of [production] [the quality system] has not been [adequately] validated for its
intended use according to an established protocol. Specifically, ***
Procedures for design validation have not been [adequately] established. Specifically,***
Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its
specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, ***
Complaint files are not [adequately] maintained. Specifically, ***

Procedures to control environmental conditions have not been [adequately] established. Specifically,
***
The design history file [was not established] [does not demonstrate that the design was developed
following the approved design plan] [does not demonstrate that the design was developed following the
requirements of 21 CFR 820].
Document control procedures have not been [established] [maintained]. Specifically,***
Personnel training is not documented. Specifically, ***
Process validation [activities] [results] have not been [documented] [approved] [adequately
documented] [adequately approved]. Specifically, ***
Acceptance activities were not [documented] [maintained as part of the device history record]
[adequately documented] [adequately maintained as part of the device history record]. Specifically, ***
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device has malfunctioned and would be likely to
cause or contribute to a death or serious injury if the malfunction were to recur. Specifically, ***
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device may have caused or contributed to a death
or serious injury. Specifically, ***
Procedures for monitoring and control of process parameters for a validated process have not been
[adequately] established. Specifically, ***
Procedures to control labeling activities have not been [adequately] established. Specifically, ***
Schedules for the adjustment, cleaning, and other maintenance of equipment have not been
[adequately] established. Specifically, ***
Records of complaint investigations do not include required information. Specifically, ***
Quality [audits] [reaudits] have not been performed. Specifically, ***
Procedures for rework of nonconforming product have not been [adequately] established. Specifically,
***
The evaluation of potential [suppliers] [contractors] [consultants] was not documented. Specifically, ***
Management with executive responsibility has not reviewed the suitability and effectiveness of the
quality system [at defined intervals] [with sufficient frequency]. Specifically, ***
Procedures for design review have not been [adequately] established. Specifically,***
Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.
Procedures for design verification have not been [adequately] established. Specifically,***
Products that do not conform to specifications are not adequately controlled. Specifically, ***
Quality audits were not performed [at defined intervals] [at sufficient frequency] to determine whether
the quality system activities and results comply with quality system procedures. Specifically, ***
The device history record does not include, or refer to the location of any unique device identifier (UDI)
or universal product code (UPC). Specifically, ***
Individuals who conduct quality audits have direct responsibility for the matters being audited.
Specifically, ***
Procedures that define the responsibility for review and the authority for the disposition of
nonconforming product have not been [adequately] established. Specifically, ***
Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately]
established. Specifically, ***
Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device
conforms to its specifications. Specifically, ***
The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors]
[consultants] was not clearly defined. Specifically, ***
Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately]
The written MDR Procedure does not include an internal system which provides for the timely and
effective [identification] [communication] [evaluation] of events that may be subject to medical device
reporting requirements. Specifically, ***
Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying
the acceptability of process capability and product characteristics have not been [adequately]
established. Specifically,***
Sampling plans are not [written] [based on valid statistical rationale]. Specifically, ***
Rework and reevaluation activities have not been [fully] documented in the device history record.
Specifically, ***
Procedures for design input have not been [adequately] established. Specifically,***
Quality system procedures and instructions have not been established. Specifically,***
Procedures for design transfer have not been [adequately] established. Specifically,***
Equipment [calibrations] [inspections] [checks] [maintenance activities] have not been documented.
Specifically, ***
The organizational structure has not been [adequately] established and maintained to ensure that
devices are [designed] [produced] in accordance with 21 CFR 820. Specifically, ***
Documents were [not reviewed] [not approved] by designated individual(s) prior to issuance .
Specifically, ***
An investigation was not conducted in accordance with [the signed agreement] [the investigational plan]
[applicable FDA regulations] [conditions of approval imposed by an IRB] [conditions of approval imposed
by FDA]. Specifically, ***
Design validation did not ensure the device conforms to defined user needs and intended uses.
Specifically, ***
There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product
or service. Specifically, ***
The design verification results, including [identification of the design] [method(s)] [the date] [the
individual(s) performing the verification], were not [adequately] documented in the design history file.
Specifically, ***
The design review results, including [identification of the design] [the date] [the individual(s) performing
the review], were not documented in the design history file. Specifically, ***
Not all complaints have been [adequately] reviewed and evaluated to determine whether an
investigation is necessary. Specifically, ***
Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to
meet specified requirements. Specifically, ***
A justification for not reporting the correction or removal action to FDA that included [conclusions]
[follow-ups] [reviews] by a designated person was not included in the record. Specifically,***
Design verification does not confirm that design output meets design input requirements. Specifically,
***
Procedures for the [acceptance] [control] of in-process product have not been [adequately] established.
Specifically, ***
Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified
requirements] have not been [adequately] established. Specifically, ***
Results of the design risk analysis were not [adequately] documented. Specifically, ***
For an investigational study, [qualified investigators were not selected] [investigators were not provided
with the information they need to conduct an investigation properly] [proper monitoring was not
ensured] [IRB review and approval were not ensured] [an IDE application was not submitted to FDA for a
significant risk study] [reviewing IRBs were not promptly informed of significant new information about
an investigation] [FDA was not promptly informed of significant new information about an investigation].
Specifically, ***
Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are
being] used. Specifically, ***_x000D_
_x000D_
The acceptance status of product was not [identified to indicate conformance or nonconformance with
acceptance criteria] [maintained]. Specifically, ***
A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations
occurred. Specifically, ***
The [quality policy] [quality objectives] was/were not established by management with executive
responsibility. Specifically, ***
Design input requirements were not [adequately] documented. Specifically, ***
Procedures to prevent contamination of equipment or product by substances that may have an adverse
effect on product quality have not been [adequately] established. Specifically, ***
[Installation instructions] [inspection instructions] [test procedures] have not been [adequately]
The documentation of approval of documents does not include [the document approval date] [the
signature of the approving official]. Specifically, ***
Validation of device software [was not performed] [is inadequate] [is incomplete]. Specifically, ***
Procedures for the control of storage areas and stock rooms have not been [adequately] established.
Specifically,***
Procedures for design output have not been [adequately] established. Specifically,***
Results of the validation of the device software were not [adequately] documented. Specifically, ***
Procedures for identifying product during all stages of receipt, production, distribution, and installation
have not been [adequately] established. Specifically, ***
The written MDR procedure does not include an internal system which provides for a standardized
review process/procedure for determining when an event meets the criteria for reporting. Specifically,
***
The written MDR procedure does not include an internal system which provides for timely transmission
of complete medical device reports to [FDA] [manufacturers]. Specifically, ***
Acceptance criteria were not established prior to the performance of validation activities. Specifically,
***
The design was not validated [under defined operating conditions] [using initial production units, lots or
batches or their equivalents]. Specifically, ***
Records of changes to documents were not [adequately] maintained. Specifically, ***
Design output was not [adequately] documented before release. Specifically, ***
The written MDR procedure does not include documentation and recordkeeping requirements for all
information that was evaluated to determine if an event was reportable. Specifically, ***
A quality plan has not been [adequately] established. Specifically, ***

Design plans that describe or reference the design and development activities and define responsibility
for implementation have not been [adequately] established. Specifically, ***
Complaints representing events that are MDR reportable were not [promptly reviewed, evaluated, and
investigated by a designated individual] [maintained in a separate portion of the complaint files] [clearly
identified]. Specifically, ***
The design was not validated under actual or simulated use conditions. Specifically, ***
Software validation activities and results for computers or automated data processing systems used as
part of [production] [the quality system] have not been [adequately] documented. Specifically, ***
Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of
producing valid results]. Specifically, ***
Procedures to ensure sampling methods are adequate for their intended use have not been [adequately]
Acceptance or rejection of incoming product was not documented. Specifically, ***
Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the
DHR. Specifically, ***
No management representative had been appointed to ensure that quality system requirements are
met, and to report to management on the performance of the quality system. Specifically, ***
The results of design validation, including [identification of the design] [method(s)] [the date] [the
individual(s) performing validation], were not [adequately] documented in the design history file.
Specifically, ***
An investigation was not conducted according to the [signed agreement] [investigational plan]
[applicable FDA regulations]. Specifically, ***
Records of changes did not include [a description of the change] [identification of the affected
documents] [the signature of the approving official(s)] [the approval date] [when the change became
effective]. Specifically, ***_x000D_
_x000D_
Purchasing data that clearly describe or reference specified requirements for purchased or otherwise
received product and services have not been [approved] [established] [adequately approved]
[adequately established]. Specifically, ***
Evaluations of out-of-calibration equipment and remedial actions taken were not documented.
Specifically, ***
The DHR does not include [complete] records of examination and release of device labeling, including
date and signature of the examiner. Specifically, ***
Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***
Service reports [are not documented] [do not include the required information]. Specifically, ***
There is [no] [inadequate] documentation of [monitoring and control methods and data] [the date
performed] [the individual performing the process] [the major equipment used] for a validated process.
Specifically, ***
There is no documentation of the [review and evaluation of a process] [revalidation of a process]
performed in response to changes or process deviations. Specifically, ***
The results and/or dates of management reviews are not documented. Specifically, ***
Records of each subject's [case history] [exposure to the investigational device] are not all [accurate]
[complete] [current]. Specifically, ***
Procedures for control and distribution of finished devices have not been [adequately] established.
Specifically,***
The dates of quality [audits] [reaudits] have not been documented. Specifically, ***
Required records [are not maintained at a location that is reasonably accessible to responsible officials of
the manufacturer and to employees of the FDA] [were not made readily available for review and copying
by the FDA] [are not legible] [are not stored to minimize deterioration and prevent loss] [are not backed
up when stored in automated data processing systems]. Specifically, ***
Records for complaints where no investigation was made do not include required information.
Specifically, ***
Calibration procedures do not include [specific directions and limits for accuracy and precision]
[provisions for remedial action]. Specifically, ***
When test/measurement equipment was found to not meet accuracy and precision limits, [no]
[inadequate] action was taken to [bring the equipment into calibration] [evaluate whether there was any
adverse effect on the device's quality]. Specifically, ***
In-process inspections, tests, or other verification activities and approvals were not documented.
Specifically, ***
Personnel do not have the necessary [education] [background] [training] [experience] to perform their
jobs. Specifically, ***
The [appropriate design, construction, placement, and installation of manufacturing equipment have not
been ensured] [equipment used in the manufacturing process does not meet specified requirements].
Specifically, ***
Distribution records [were not maintained] [do not include or refer to the location of required
information]. Specifically, ***
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in
writing to FDA. Specifically, ***
Periodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance
schedules [were not documented]. Specifically, ***
Labeling was not sufficiently examined by a designated individual for accuracy including unique device
identifier (UDI) or universal product code (UPC). Specifically, ***
A 5 day report was not submitted to FDA on Form 3500A within 5 workdays of becoming aware that a
reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm
to the public health. Specifically, ***
A supplemental report was not submitted to FDA within one month following receipt of information that
was not provided when the initial report was submitted. Specifically, ***
Design plans were not [reviewed] [updated] [approved] as design and development evolves. Specifically,
***
An investigator was not complying with the [signed agreement] [investigational plan] [requirements of
the regulations] [conditions of approval imposed by the IRB or FDA] and [compliance of the investigator
was not promptly secured] [shipments of the investigational device to the investigator were not
discontinued] [the investigator's participation in the investigation was not terminated]. Specifically, ***
Procedures for the use and removal of manufacturing material have not been [adequately] established.
Specifically, ***
Procedures for product handling have not been [adequately] established. Specifically,***_x000D_
_x000D_
Procedures for conducting periodic inspections to ensure adherence to equipment maintenance

schedules have not been [adequately] established. Specifically, ***
The person installing the device did not [adequately] document the inspection and test results to
demonstrate proper installation.
Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not
been implemented. Specifically, ***
Documentation of rework and reevaluation activities does not include a determination of whether there
has been any adverse effect from rework upon the product. Specifically, ***
Management with executive responsibility has not ensured that the quality policy is understood,
implemented and maintained at all levels of the organization. Specifically, ***
The management representative has not ensured that the quality system requirements are effectively
established and maintained. Specifically, ***
A report of the required information regarding device correction and removal actions was not sent to
FDA within 10 days of initiating the correction or removal. Specifically, ***
A signed agreement was not obtained from each participating investigator that includes [sufficient
accurate financial disclosure information to allow the sponsor to submit a complete and accurate
certification or disclosure statement] [a commitment to promptly update financial disclosure information
if any relevant changes occur during the investigation and for one year following completion of the
study]. Specifically, ***
A clinical investigation that was determined to be a non-significant risk device study does not meet the
abbreviated requirements for investigational device exemptions (IDEs). Specifically, ***
The device design was not correctly translated into production specifications. Specifically, ***
Procedures for identifying with a control number each unit, lot, or batch of implantable or life
supporting, life sustaining finished devices or appropriate components have not been [adequately]
The written MDR procedure does not include documentation and recordkeeping requirements for all
Medical Device Reports and information submitted to [FDA] [device manufacturers]. Specifically, ***
An MDR report submitted to FDA did not include all information that was reasonably known to the
manufacturer. Specifically, ***
The firm did not obtain and provide FDA with information that is incomplete or missing from reports
submitted by user facilities, distributors, and other initial reporters. Specifically, ***
Design output was not [reviewed] [approved] before release. Specifically, ***
A signed agreement that includes a statement of the investigator's commitment to conduct an
investigation in accordance with the [agreement] [investigational plan] [applicable FDA regulations]
[conditions of approval imposed by the reviewing IRB] [conditions of approval imposed by the FDA] was
not obtained from each participating investigator. Specifically, ***
A signed agreement that includes a statement of the investigator's commitment to supervise all testing
of the device involving human subjects was not obtained from each participating investigator.
Specifically, ***
A signed agreement that includes a statement of the investigator's commitment to ensure that the
requirements for obtaining informed consent are met was not obtained from each participating
investigator. Specifically, ***
Monitors that are qualified by [training] [experience] were not chosen to monitor the investigational
study. Specifically, ***
The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected.
Specifically, ***
Informed consent was not obtained in accordance with the regulations regarding the protection of
human subjects. Specifically, ***
Records documenting that informed consent was obtained for each subject prior to participation in the
study are not all [accurate] [complete] [current]. Specifically, ***
Records for each subject concerning [previous medical history] [condition upon entering the
investigation] [condition during the course of the investigation] [all diagnostic test results] are not all
[accurate] [complete] [current]. Specifically, ***
Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA],
including required reports are not all [accurate] [complete] [current]. Specifically, ***
Records of shipment of an investigational device that include the [name and address of the consignee]
[type and quantity of device] [date of shipment] [batch number or code mark] reports are not all
[accurate] [complete] [current]. Specifically, ***
Records concerning [anticipated adverse device effects] [unanticipated adverse device effects]
[complaint] reports are not all [accurate] [complete] [current]. Specifically, ***
A complete and accurate report of an unanticipated adverse device effect was not prepared and
submitted [within 10 working days after first learning of the effect] to [the sponsor] [the reviewing IRB].
Specifically, ***
Notification of withdrawal of approval of an investigation by a reviewing IRB was not sent [within five
working days of withdrawal] to [FDA] [all reviewing IRBs] [all participating investigators]. Specifically, ***
Equipment used in the manufacturing process has not been appropriately [designed] [constructed]
[placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***
The device master record does not include or refer to the location of device software specifications.
Specifically, ***
The quality system record has not been [adequately] maintained. Specifically, ***
Documents were not available at all locations for which they are designated, used, or otherwise
necessary. Specifically, ***
Labels were stored such that mix-ups were possible. Specifically, ***
Although a control number is required for this type of device, the device does not carry its control
number through distribution. Specifically, ***
Service reports were not analyzed following appropriate statistical methods. Specifically, ***
Service reports that represent MDR reportable events were not automatically considered complaints and
processed in accordance with the requirements of 21 CFR 820.198. Specifically, ***
Investigation records of MDR reportable complaints do not include required information. Specifically,
***
The manufacturer's formally designated complaint unit is located outside of the United States and
complaint records are not reasonably accessible in the United States. Specifically, ***
Design input requirements were not [reviewed] [approved] by designated individual(s). Specifically, ***
A violation of the FD&C Act involving a device which might present a risk to health was not reported to
FDA. Specifically, ***
A description of the events that led to the correction or removal actions was not contained in the record.
Specifically,***
A copy of all communications regarding the correction or removal action was not contained in the
record. Specifically,***
The importer failed to submit a report to FDA on FDA form 3500A, with a copy to the manufacturer,
within 30 days after receiving information that one of its marketed devices may have caused or
contributed to a [death] [serious injury]. Specifically, ***
The importer failed to submit a report to the manufacturer on FDA Form 3500A within 30 days
concerning information that one of the devices marketed by the importer has malfunctioned and that
such device or a similar device marketed by the importer would be likely to cause or contribute to a
death or serious injury if the malfunction were to recur. Specifically, ***
An initial establishment registration was not submitted within 30 days after starting an operation
requiring registration. Specifically,
The label for an investigational device does not include [the name and place of business of manufacturer,
packer, or distributor] [the quantity of contents] [the statement "CAUTION -- Investigational device.
Limited by Federal (or United States) law to investigational use."]. Specifically, ***
The sponsor was not supplied [sufficient financial information to allow submission of complete and
accurate certification or disclosure statements] [financial disclosure updates when a relevant change
occurred during the course of the study or within one year following study completion]. Specifically, ***
Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete]
[current]. Specifically,***
There are no written procedures for monitoring an investigational device study. Specifically,***
A signed investigator agreement was not obtained from each participating investigator . Specifically,***
Frequency
312
240
151
133
120
111
86
67
54
54
52
51
44
44
43
43
42
42
40
40
39
39
37
36
34
33
31
28
27
24
24
23
22
21
20
20
20
19
19
19
18
18
18
17
17
16
16
16
16
15
15
14
14
14
13
13
13
13
13
13
12
12
12
11
11
11
11
11
11
10
10
10
10
10
7
6
6
6
4
4
3
3
1
1
1
1
1
Drugs 1105 21 CFR 211.22(d)
Drugs 2027 21 CFR 211.192
Drugs 3603 21 CFR 211.160(b)
Drugs 1361 21 CFR 211.100(a)
Drugs 1213 21 CFR 211.67(a)
Drugs 1883 21 CFR 211.165(a)
Drugs 3585 21 CFR 211.110(a)
Drugs 1451 21 CFR 211.113(b)
Drugs 1263 21 CFR 211.68(b)
Drugs 1914 21 CFR 211.166(a)
Drugs 1177 21 CFR 211.63
Drugs 1215 21 CFR 211.67(b)
Drugs 1274 21 CFR 211.68(a)
Drugs 1112 21 CFR 211.25(a)
Drugs 1434 21 CFR 211.42(c)(10)(iv)

Drugs 1890 21 CFR 211.165(e)
Drugs 2009 21 CFR 211.188
Drugs 1452 21 CFR 211.113(b)
Drugs 1358 21 CFR 211.100(b)
Drugs 1809 21 CFR 211.160(a)
Drugs 1111 21 CFR 211.25(a)
Drugs 2031 21 CFR 211.194(a)
Drugs 1435 21 CFR 211.42(c)(10)(v)
Drugs 9001 21 CFR 211.22(a)
Drugs 4402 21 CFR 211.192
Drugs 4389 21 CFR 211.198(a)
Drugs 4303 21 CFR 211.67(b)
Drugs 1450 21 CFR 211.113(a)
Drugs 1912 21 CFR 211.166(a)
Drugs 4391 21 CFR 211.180(e)(2)
Drugs 4314 21 CFR 211.84(d)(2)

Drugs 2012 21 CFR 211.188(b)
Drugs 4576 21 CFR 211.192
Drugs 2401 21 CFR 211.194(a)(4)
Drugs 3632 21 CFR 211.170(b)
Drugs 1540 21 CFR 211.125(a)
Drugs 1767 21 CFR 211.137(a)
Drugs 1920 21 CFR 211.166(a)(3)
Drugs 2028 21 CFR 211.192
Drugs 2419 21 CFR 211.198(a)
Drugs 1133 21 CFR 211.25(a)
Drugs 1885 21 CFR 211.165(b)
Drugs 4342 21 CFR 211.142(b)
Drugs 3602 21 CFR 211.160(a)
Drugs 1787 21 CFR 211.80(a)
Drugs 1810 21 CFR 211.160(a)
Drugs 3565 21 CFR 211.58
Drugs 1844 21 CFR 211.84(d)(2)
Drugs 18938 FDCA 501(a)(2)(A)
Drugs 1033 21 CFR 211.22(a)

Drugs 1098 21 CFR 211.22(c)
Drugs 1227 21 CFR 211.67(c)
Drugs 1975 21 CFR 211.182
Drugs 2026 21 CFR 211.192
Drugs 3547 21 CFR 211.46(b)
Drugs 3611 21 CFR 211.160(b)(3)
Drugs 4352 21 CFR 211.160(b)(4)
Drugs 1049 21 CFR 211.22(a)
Drugs 1159 21 CFR 211.28(a)
Drugs 1448 21 CFR 211.111
Drugs 1932 21 CFR 211.167(a)
Drugs 3559 21 CFR 211.56(a)
Drugs 3572 21 CFR 211.100(b)
Drugs 1194 21 CFR 211.42(c)
Drugs 1790 21 CFR 211.80(b)
Drugs 3571 21 CFR 211.100(a)
Drugs 4401 21 CFR 211.186(b)(9)
Drugs 1220 21 CFR 211.67(b)(3)
Drugs 1270 21 CFR 211.68(b)

Drugs 1942 21 CFR 211.180(e)
Drugs 3613 21 CFR 211.160(b)(4)
Drugs 4315 21 CFR 211.84(d)(2)
Drugs 4340 21 CFR 211.142
Drugs 17764 21 CFR 212.20(e)
Drugs 21377 FDCA 501(a)(2)(A)
Drugs 1833 21 CFR 211.84(d)(1)
Drugs 1879 21 CFR 211.180(c)
Drugs 4382 21 CFR 211.198(b)(2)
Drugs 18961 FDCA 501(a)(2)(A)
Drugs 21376 21 CFR 212.30(a)
Drugs 1421 21 CFR 211.42(c)(10)
Drugs 1891 21 CFR 211.165(f)
Drugs 3583 21 CFR 211.110(a)
Drugs 4306 21 CFR 211.80(a)
Drugs 4357 21 CFR 211.166(a)
Drugs 1219 21 CFR 211.67(b)(2)
Drugs 1395 21 CFR 211.103
Drugs 1430 21 CFR 211.42(c)(10)(i)
Drugs 1433 21 CFR 211.42(c)(10)(iii)

Drugs 1842 21 CFR 211.84(d)(1)
Drugs 1943 21 CFR 211.180(e)(1)
Drugs 2020 21 CFR 211.188(b)(8)
Drugs 8907 21 CFR 314.81(b)(1)(ii)
Drugs 17763 21 CFR 212.20(d)
Drugs 18956 FDCA 501(a)(2)(A)
Drugs 1162 21 CFR 211.28(a)
Drugs 1505 21 CFR 211.122(d)
Drugs 1926 21 CFR 211.166(b)
Drugs 2033 21 CFR 211.194(c)
Drugs 3570 21 CFR 211.100(a)
Drugs 3629 21 CFR 211.170(b)
Drugs 4413 21 CFR 211.194(a)(8)
Drugs 21295 21 CFR 211.110(b)
Drugs 1169 21 CFR 211.42(a)
Drugs 1436 21 CFR 211.42(c)(10)(vi)
Drugs 1550 21 CFR 211.125(f)
Drugs 1801 21 CFR 211.84(a)
Drugs 1823 21 CFR 211.84(c)(4)

Drugs 2008 21 CFR 211.186(a)
Drugs 2034 21 CFR 211.194(d)
Drugs 2205 21 CFR 211.186(b)(9)
Drugs 4373 21 CFR 211.188(b)(7)
Drugs 4399 21 CFR 211.186(b)(7)
Drugs 4418 21 CFR 211.42(b)
Drugs 8911 21 CFR 314.81(b)(1)(ii)
Drugs 18936 FDCA 501(a)(2)(A)
Drugs 18970 FDCA 501(a)(2)(A)
Drugs 18973 FDCA 501(a)(2)(A)
Drugs 21373 21 CFR 212.30(b)
Drugs 1079 21 CFR 211.22(a)
Drugs 1136 21 CFR 211.25(c)
Drugs 1256 21 CFR 211.68(b)
Drugs 3616 21 CFR 211.165(d)
Drugs 4304 21 CFR 211.68(b)
Drugs 4353 21 CFR 211.160(b)(4)

Drugs 4359 21 CFR 211.170(b)(1)
Drugs 4406 21 CFR 211.194(a)(2)
Drugs 6730 21 CFR 314.80(b)
Drugs 6732 21 CFR 314.80(c)(1)(i)
Drugs 17812 21 CFR 212.50
Drugs 17851 21 CFR 212.60(c)
Drugs 18008 FDCA 503B(a)(10)
Drugs 18939 FDCA 501(a)(2)(A)
Drugs 18941 FDCA 501(a)(2)(A)
Drugs 18942 FDCA 501(a)(2)(A)
Drugs 18960 FDCA 501(a)(2)(A)
Drugs 1174 21 CFR 211.42(b)
Drugs 1223 21 CFR 211.67(b)(5)
Drugs 1626 21 CFR 211.130
Drugs 1851 21 CFR 211.84(e)
Drugs 2011 21 CFR 211.188(a)
Drugs 2023 21 CFR 211.188(b)(11)
Drugs 3445 21 CFR 211.65(a)
Drugs 3567 21 CFR 211.84(d)(2)
Drugs 3582 21 CFR 211.105(a)

Drugs 3607 21 CFR 211.160(b)(2)
Drugs 3610 21 CFR 211.160(b)(3)
Drugs 4305 21 CFR 211.68(b)
Drugs 4320 21 CFR 211.84(d)(6)
Drugs 4338 21 CFR 211.150(b)
Drugs 4344 21 CFR 211.160(b)(1)
Drugs 4372 21 CFR 211.188(b)(8)
Drugs 18953 FDCA 501(a)(2)(A)
Drugs 18954 FDCA 501(a)(2)(A)
Drugs 18955 FDCA 501(a)(2)(A)
Drugs 1251 21 CFR 211.42(c)(1)
Drugs 1261 21 CFR 211.68(a)
Drugs 1495 21 CFR 211.122(a)
Drugs 1496 21 CFR 211.122(a)
Drugs 1504 21 CFR 211.122(d)
Drugs 1728 21 CFR 211.87
Drugs 1777 21 CFR 211.150(b)
Drugs 1843 21 CFR 211.84(d)(2)
Drugs 1849 21 CFR 211.84(d)(6)

Drugs 1886 21 CFR 211.165(c)
Drugs 1917 21 CFR 211.166(a)(1)
Drugs 1978 21 CFR 211.182
Drugs 3562 21 CFR 211.56(c)
Drugs 3623 21 CFR 211.170(a)
Drugs 4324 21 CFR 211.110(b)
Drugs 4350 21 CFR 211.160(b)(3)
Drugs 4360 21 CFR 211.170(b)
Drugs 4386 21 CFR 211.198(b)
Drugs 4387 21 CFR 211.198(a)
Drugs 17849 21 CFR 212.60(a)
Drugs 18009 FDCA 503B(a)(10)
Drugs 18937 FDCA 501(a)(2)(A)
Drugs 18944 FDCA 501(a)(2)(A)
Drugs 18963 FDCA 501(a)(2)(A)
Drugs 21284 FDCA 501(a)(2)(A)
Drugs 1086 21 CFR 211.22(b)
Drugs 1396 21 CFR 211.42(c)(2)

Drugs 1413 21 CFR 211.42(c)(5)
Drugs 1629 21 CFR 211.130(a)
Drugs 1724 21 CFR 211.134(b)
Drugs 1725 21 CFR 211.134(c)
Drugs 1770 21 CFR 211.137(d)
Drugs 1803 21 CFR 211.84(b)
Drugs 1869 21 CFR 211.94(c)
Drugs 1918 21 CFR 211.166(a)(2)
Drugs 1928 21 CFR 211.166(c)(1)
Drugs 2001 21 CFR 211.184(b)
Drugs 2004 21 CFR 211.184(d)
Drugs 2007 21 CFR 211.186(a)
Drugs 2399 21 CFR 211.194(a)(2)
Drugs 2420 21 CFR 211.198(a)
Drugs 3557 21 CFR 211.52
Drugs 3561 21 CFR 211.56(b)
Drugs 4345 21 CFR 211.160(b)(1)
Drugs 4351 21 CFR 211.160(b)(3)
Drugs 4355 21 CFR 211.165(c)

Drugs 4366 21 CFR 211.188(a)
Drugs 4404 21 CFR 211.194(a)(1)
Drugs 6831 21 CFR 314.80(c)(2)
Drugs 6832 21 CFR 314.80(c)(2)
Drugs 10022 21 CFR 310.305(a)
Drugs 17962 21 CFR 361.1(c)(2)
Drugs 18972 FDCA 501(a)(2)(A)
Drugs 21294 21 CFR 211.110(b)
Drugs 1134 21 CFR 211.25(b)
Drugs 1163 21 CFR 211.28(b)
Drugs 1224 21 CFR 211.67(b)(6)
Drugs 1266 21 CFR 211.42(d)
Drugs 1411 21 CFR 211.105(b)
Drugs 1418 21 CFR 211.42(c)(7)
Drugs 1420 21 CFR 211.42(c)(9)
Drugs 1431 21 CFR 211.42(c)(10)(ii)
Drugs 1632 21 CFR 211.130(c)
Drugs 1636 21 CFR 211.130(e)
Drugs 1722 21 CFR 211.134(a)

Drugs 1768 21 CFR 211.137(b)
Drugs 1774 21 CFR 211.142(a)
Drugs 1796 21 CFR 211.80(d)
Drugs 1798 21 CFR 211.82(b)
Drugs 1846 21 CFR 211.84(d)(3)
Drugs 1876 21 CFR 211.180(b)
Drugs 1999 21 CFR 211.184(a)
Drugs 2005 21 CFR 211.184(e)
Drugs 2022 21 CFR 211.188(b)(10)
Drugs 2044 21 CFR 211.196
Drugs 2397 21 CFR 211.194(a)(1)
Drugs 2404 21 CFR 211.194(a)(6)
Drugs 2405 21 CFR 211.194(a)(7)
Drugs 2567 21 CFR 211.198(a)
Drugs 3545 21 CFR 211.44

Drugs 3546 21 CFR 211.46(a)
Drugs 3549 21 CFR 211.46(c)
Drugs 3591 21 CFR 211.110(b)
Drugs 3592 21 CFR 211.110(c)

Drugs 3594 21 CFR 211.110(d)
Drugs 3604 21 CFR 211.160(b)(1)
Drugs 3614 21 CFR 211.160(b)(4)
Drugs 3615 21 CFR 211.160(b)(4)
Drugs 3639 21 CFR 211.204
Drugs 4307 21 CFR 211.80(d)
Drugs 4316 21 CFR 211.84(d)(3)
Drugs 4325 21 CFR 211.110(a)
Drugs 4328 21 CFR 211.122(a)
Drugs 4336 21 CFR 211.150
Drugs 4343 21 CFR 211.160(b)(1)
Drugs 4354 21 CFR 211.165(d)
Drugs 4369 21 CFR 211.188(b)(11)
Drugs 4375 21 CFR 211.188(b)(5)
Drugs 4380 21 CFR 211.198(b)(3)
Drugs 6829 21 CFR 314.80(c)(2)
Drugs 6835 21 CFR 314.80(d)
Drugs 6842 21 CFR 314.80(j)

Drugs 8912 21 CFR 314.81(b)(2)
Drugs 17723 21 CFR 212.10
Drugs 17813 21 CFR 212.50(a)
Drugs 17853 21 CFR 212.60(d)
Drugs 17855 21 CFR 212.60(e)
Drugs 17863 21 CFR 212.60(g)(3)
Drugs 17865 21 CFR 212.60(g)(5)
Drugs 17898 21 CFR 212.71(c)
Drugs 17958 21 CFR 361.1(c)(2)
Drugs 18948 FDCA 501(a)(2)(A)
Drugs 18949 FDCA 501(a)(2)(A)
Drugs 18966 FDCA 501(a)(2)(A)
Drugs 18971 FDCA 501(a)(2)(A)
Drugs 21296 21 CFR 211.186(a)
Drugs 21297 21 CFR 211.186(a)
Drugs 1164 21 CFR 211.28(c)
Drugs 1388 21 CFR 211.101(d)
Drugs 1398 21 CFR 211.42(c)(3)
Drugs 1409 21 CFR 211.42(c)(4)

Drugs 1419 21 CFR 211.42(c)(8)
Drugs 1449 21 CFR 211.111
Drugs 1454 21 CFR 211.115(a)
Drugs 1506 21 CFR 211.122(e)
Drugs 1541 21 CFR 211.125(b)
Drugs 1545 21 CFR 211.125(c)
Drugs 1630 21 CFR 211.130(b)
Drugs 1633 21 CFR 211.130(d)
Drugs 1797 21 CFR 211.82(a)
Drugs 1802 21 CFR 211.84(b)
Drugs 1818 21 CFR 211.84(c)(2)
Drugs 1845 21 CFR 211.84(d)(3)
Drugs 1868 21 CFR 211.94(b)
Drugs 1874 21 CFR 211.180(b)
Drugs 1933 21 CFR 211.167(a)
Drugs 1957 21 CFR 211.180(e)(2)
Drugs 1976 21 CFR 211.182
Drugs 1979 21 CFR 211.182

Drugs 2014 21 CFR 211.188(b)(2)
Drugs 2015 21 CFR 211.188(b)(3)
Drugs 2016 21 CFR 211.188(b)(4)
Drugs 2018 21 CFR 211.188(b)(6)
Drugs 2019 21 CFR 211.188(b)(7)
Drugs 2086 21 CFR 211.208
Drugs 2090 21 CFR 211.208
Drugs 2198 21 CFR 211.186(b)(3)
Drugs 2203 21 CFR 211.186(b)(7)
Drugs 2400 21 CFR 211.194(a)(3)
Drugs 2402 21 CFR 211.194(a)(5)
Drugs 2406 21 CFR 211.194(a)(8)
Drugs 2572 21 CFR 211.198(b)
Drugs 2619 21 CFR 211.198(b)(2)
Drugs 3548 21 CFR 211.46(c)
Drugs 3553 21 CFR 211.48(a)
Drugs 3555 21 CFR 211.48(b)
Drugs 3558 21 CFR 211.52
Drugs 3566 21 CFR 211.84(c)(4)
Drugs 3569 21 CFR 211.89
Drugs 3573 21 CFR 211.101(b)
Drugs 3578 21 CFR 211.101(c)(1)

Drugs 3581 21 CFR 211.101(d)
Drugs 3586 21 CFR 211.110(a)(1)
Drugs 3605 21 CFR 211.160(b)(1)
Drugs 3608 21 CFR 211.160(b)(2)
Drugs 3612 21 CFR 211.160(b)(3)
Drugs 3630 21 CFR 211.170(b)
Drugs 3631 21 CFR 211.170(b)
Drugs 3633 21 CFR 211.170(b)(1)
Drugs 4302 21 CFR 211.56(b)
Drugs 4317 21 CFR 211.84(d)(3)
Drugs 4322 21 CFR 211.101(d)
Drugs 4323 21 CFR 211.115(a)
Drugs 4330 21 CFR 211.130(e)
Drugs 4347 21 CFR 211.160(b)(2)
Drugs 4356 21 CFR 211.166(b)
Drugs 4364 21 CFR 211.176
Drugs 4368 21 CFR 211.188(b)(12)
Drugs 4376 21 CFR 211.188(b)(4)

Drugs 4377 21 CFR 211.188(b)(3)
Drugs 4378 21 CFR 211.188(b)(2)
Drugs 4379 21 CFR 211.188(b)(1)
Drugs 4388 21 CFR 211.198(a)
Drugs 4409 21 CFR 211.194(a)(4)
Drugs 6709 21 CFR 310.305(c)(2)
Drugs 6731 21 CFR 314.80(c)
Drugs 6830 21 CFR 314.80(c)(2)
Drugs 6833 21 CFR 314.80(c)(2)(ii)(A)
Drugs 8935 FDCA 760(b)(1)
Drugs 8936 FDCA 760(b)(1)
Drugs 17753 21 CFR 212.30(c)
Drugs 17759 21 CFR 212.20(c)
Drugs 17775 21 CFR 212.40(c)
Drugs 17784 21 CFR 212.40(c)(2)
Drugs 17814 21 CFR 212.50(b)
Drugs 17821 21 CFR 212.50(b)(6)

Drugs 17822 21 CFR 212.50(b)(7)
Drugs 17832 21 CFR 212.50(c)(4)
Drugs 17841 21 CFR 212.50(d)
Drugs 17857 21 CFR 212.60(f)
Drugs 17859 21 CFR 212.60(g)
Drugs 17877 21 CFR 212.70(c)
Drugs 17883 21 CFR 212.70(d)(3)
Drugs 17886 21 CFR 212.70(e)
Drugs 17896 21 CFR 212.71(a)
Drugs 17904 21 CFR 212.80(d)
Drugs 17913 21 CFR 212.100(a)
Drugs 17941 21 CFR 212.71(b)
Drugs 17993 21 CFR 361.1(f)(1)
Drugs 17994 21 CFR 361.1(f)(2)
Drugs 18003 21 CFR 361.1(f)(11)
Drugs 18004 21 CFR 361.1(f)(12)
Drugs 18025 21 CFR 314.80(c)(2)(ii)(B)

Drugs 18026 21 CFR 314.80(f)(2)
Drugs 18933 FDCA 501(a)(2)(A)
Drugs 18934 FDCA 501(a)(2)(A)
Drugs 18940 FDCA 501(a)(2)(A)
Drugs 18943 FDCA 501(a)(2)(A)
Drugs 18946 FDCA 501(a)(2)(A)
Drugs 18950 FDCA 501(a)(2)(A)
Drugs 18957 FDCA 501(a)(2)(A)
Drugs 18959 FDCA 501(a)(2)(A)
Drugs 18962 FDCA 501(a)(2)(A)
Drugs 18964 FDCA 501(a)(2)(A)
Drugs 18968 FDCA 501(a)(2)(A)
Drugs 21352 FDCA 505-1(e)(2)(A)
Drugs 21355 FDCA 505-1(f)(3)(B)
Drugs 21360 FDCA 505-1(f)(4)
Drugs 21422 FDCA 503B(b)(2)(A)

Short Description
Procedures not in writing, fully followed
Investigations of discrepancies, failures
Scientifically sound laboratory controls
Absence of Written Procedures
Cleaning / Sanitizing / Maintenance
Testing and release for distribution
Control procedures to monitor and validate

performance
Procedures for sterile drug products
Computer control of master formula records
Lack of written stability program
Equipment Design, Size and Location
Written procedures not established/followed
Calibration/Inspection/Checking not done
Training--operations, GMPs, written procedures
Environmental Monitoring System

Test methods
Prepared for each batch, include complete information
Validation lacking for sterile drug products
SOPs not followed / documented
Following/documenting laboratory controls
Training , Education , Experience overall
Complete test data included in records
Cleaning System
Lack of quality control unit
Written record of investigation incomplete
Procedures to be written and followed
Written procedures fail to include
Procedures for non-sterile drug products
Written program not followed
Items to cover on annual reviews
Reports of Analysis (Components)

Batch production and Batch Control Record
Requirements
No written record of investigation
Complete Test Data
Annual visual exams of drug products
Strict control not exercised over labeling issued
Expiration date lacking
Valid stability test methods
Extent of discrepancy, failure investigations
Complaint Handling Procedure
GMP Training Frequency
Microbiological testing
Storage under appropriate conditions
Deviations from laboratory control requirements
Procedures To Be in Writing
Lab controls established, including changes
Buildings not maintained in good state of repair
Establish reliability of supplier's C of A
Hazardous drugs, prevention of cross-contamination
Authority lacking to review records, investigate errors

Approve or reject procedures or specs
Cleaning/maintenance records not kept
Written records kept in individual logs
Quality control unit review of records
Equipment for Environmental Control
Acceptance of drug products
Calibration - at intervals, written program, remedial

action
Approve or reject components, products
Clothing appropriate for duties performed
Establishment of time limitations
Sterility/pyrogen-free testing
Sanitation--buildings not clean, free of infestation
Procedure Deviations Recorded and Justified
Defined areas of adequate size for operations
Handling and Storage to Prevent Contamination
Changes to Procedures Not Reviewed, Approved
Complete instructions, procedures, specifications et. al.
Cleaning SOPs/instructions
input/output verification
Records reviewed annually
Establishment of calibration procedures
Testing Each Component for Conformity with Specs
Written warehousing procedures established/followed
Written QA procedures established, followed
Use of non-pharmaceutical grade components
Identity Testing of Each Component
Records not made readily available to FDA
Written record of complaint to include findings, follow-

up
Air flow quality, higher classified area
Orderly handling, prevention of mix-ups, prevention of

contamination
Aseptic Processing Area
Failing drug products not rejected
Written in-process control procedures
Written Procedures Not Followed
Results not used for expiration dates, storage cond.
Cleaning SOPs/schedules
Actual vs. theoretical yields not determined
Floors, walls, ceiling surfaces
Air Supply
Component identity verification
Review of representative number of batches
Labeling Control Records and Label Copies
Contamination, chemical or physical change,

deterioration
Determination need for investigation
Cleanliness, ISO-classified areas
Protective Apparel Not Worn
Label storage access limited to authorized personnel
Adequate number of batches on stability
Testing and standardization of standards et. al.
Approval and review of procedures
Reserve samples identified, representative, stored
Second person sign off
In-process conformity - examination, sample testing
Buildings of Suitable Size, Construction, Location
Equipment to control conditions
Procedures Written and Followed
Components withheld from use pending release
Top/Middle/Bottom container sampling

Written procedures followed
Laboratory equipment calibration records
Manufacturing Instructions and Specifications
Actual yield, % of theoretical yield
Theoretical yield statement including percentages
Adequate space lacking to prevent mix-ups and

contamination
Failure to meet specifications
Non-microbial contamination, production area
Disinfecting and cleaning agents, ISO 5 area
Disinfecting materials, aseptic processing area
Equipment procedures
Contract drug products--lack of responsibility
Inadequate number of personnel
Backup file not maintained
Acceptance criteria for sampling & testing
Written record not kept of program and validation data
Instruments, apparatus, et. al. not meeting specs

Retention time of reserve samples, in general
Suitability of testing methods verified
Failure to develop written procedures
Late submission of 15-day report
Adequate controls (general)
Analytical methods
Drug product label, outsourcer facility
Highly potent drugs, prevention of cross-contamination
Improper gowning, contamination
Personnel habits, contamination
Flow of personnel and materials, facility
Product flow through building is inadequate
Cleaning SOPs/equipment protection
Procedures are written, and followed
Rejecting When Specifications Not Met
Accurate reproduction
Identification of Persons Performing Significant Steps
Equipment construction - reactive surfaces
Component identification test
Identification of containers, lines, equipment

Acceptance of in-process materials
Drug product sample
Backup data not assured as exact and complete
Microbiological Contamination Exam
Recall facilitation
Sampling and testing procedures described
Labeling control records including specimens or copies
Actionable microbial contamination, ISO 5 area
Actionable microbial contamination, adjacent area
Ceiling tiles, cleanroom
Incoming material area
Written calibration / inspection records not kept
Written procedures describing in detail
Sampling/testing of labeling/packaging materials
Labels and labeling stored separately
Retest of approved components/containers/closures
Distribution Recall System
Component written specification
Objectionable microbiological contamination

Sampling and testing plans not described
Sample size - test intervals
Personnel dating/signing equipment log
Written procedures lacking for use of pesticides etc.
Active ingredient retained sample kept
In-process materials specifications testing
Drug products-sampling procedures/specifications
Reserve drug product sample quantity - all tests
Written complaint record to be maintained at facility
Reporting of adverse drug experience to FDA
Testing procedures
Container label, outsourcer facility
Beta-lactam drugs, inadequate sanitation
Exposure of personnel in aspectic processing
Inadequate HEPA filter, sterile product area
Disinfectant contact time
Adequate lab facilities not available
Rejected Material Area

Mfg / Processing Operations Area
Prevention of cross contamination, mix-ups
Representative samples after completion
Examinations documented
Expiration date location on labeling
Representative Samples Criteria
Containers & Closures Clean, Sterilized, Pyrogen-free
Stability sample storage conditions described
Homeopathic drugs, assessment of stability
Component Test Records
Labeling: documentation of exam and review
Signature and checking of records -- 2 persons
Laboratory Test Method Verification
Quality Control Review
Washing and toilet facilities are deficient
Written sanitation procedures lacking
Samples (various types) representative, identified

properly
Drug products - samples representative, identified

properly
Sampling and testing plans not followed

Accurate reproduction included
Sample identification and other information
Late submission of quarterly safety reports
Late submission of annual safety reports
Failure to develop written procedures
Numerical votes not in the minutes of any RDRC

meetings
Inadequate sporicidal agents, cleanroom and ISO 5 area
In-process specification, invalid
Supervisor Training/Education/Experience
Habits of good sanitation & health
Cleaning SOP/inspection
Penicillin processing area not kept separate
Distinctive ID or code not recorded in batch record
Quarantined Drug Products Area
Control / Lab Operations Area
Temperature / Humidity Controls
Lot or control number assigned
Packaging line inspection before use
Correct labels during finishing operations

Storage conditions
Quarantine - actual practice
Identification of Each Lot in Each Shipment
Quarantine Storage of Components
Establish reliability of supplier's C of A
Record maintenance 1 year (except exempt OTC)
Record information required
Records of disposition of rejected material
Documentation of Sampling Performed
Distribution Record Requirements
Description and Identification of Samples
Comparison of Test Results to Specifications
Identification of Person Performing the Testing
Adverse Drug Experience
Adequate lighting not provided

Adequate ventilation not provided
Air recirculation of dust from production areas
In-process materials specifications
In-process materials characteristics testing

Rejected in-process materials not quarantined
Determination of conformance
Written calibration procedures
Test devices not meeting specifications
Returned drug procedures in writing and followed
Status of Each Lot Identified
Testing Containers & Closures Conformity with Specs
Control procedures fail to include the following
Written procedures not followed
Written distribution procedure
Incoming lots - conformance to written specs-
Acceptance/Rejection Levels
Identification of persons involved, each significant step
In-process and laboratory control results
Determination not to conduct investigation of

complaint
Failure to report non-alert ADEs
Failure to submit scientific article
Failure to maintain records

Timely submission
Personnel not qualified
Written control procedures
Supplies adequately controlled
Equipment
Complete record of all laboratory test data
Initials, signature, date
Correction of problems
Signatures of RDRC Chairman
Disruption of airflow from personnel movement
First pass air blockage, open unit with sterile product
Non-sterilized and non-depyrogenated, sterile drug
No sporicidal agents, cleanroom and ISO 5 area
Master production and control records, batch

uniformity
Master production and control records, procedure
Unauthorized Personnel in Limited Access Areas
Component addition checked by 2nd person
Released Material Area
In-Process Material Area

Released Drug Products Area
Deviations of production time limits
Reprocessing procedures not written or followed
Destruction of obsolete labeling
Examination of issued labels
Label reconciliation discrepancies

evaluation/investigation
Unlabeled filled containers controls
Examination of packaging and labeling
Examination on receipt, before acceptance
Representative Samples
Appropriate Opening of Component Containers
Container/Closure Written Test Procedure
Protection from external factors
Record maintenance 3 years (exempt OTC drugs)
Sterility/pyrogens - test methods written, followed
Review of problem drugs
Specific information required in individual logs
Chronological Order of Equipment Log Entries

Identification of Equipment and Lines
Identification of Components and In-Process Materials
Weights and Measures of Components Used
Documentation of Packaging and Labeling Area

Inspections
Documentation of Actual Yield and Theoretical Yield
Salvaging and return to marketplace
Records for salvaged drug products
Component Name and Code
Theoretical Yield and Percentages
Statement of Sample Weights and Measures
Testing Calculations
Identification of Person Performing Review of Lab

Records
Complaint File Location
Complaint Investigation/Follow-Up Findings
Air filtration system lacking in production area
Plumbing System Defects
Drains--Size, Back-siphonage Prevention
Washing and toilet facilities not provided and

accessible
Composite sample top/middle/bottom
Quarantine of Rejected Components et. al.
Measured components for manufacturing
Q.C. release check by second individual

Verification of component addition
Tablet or capsule weight variation
Specification description of sample/testing
Sampling/testing of in-process materials
Sampling/testing of drug products
Drug product reserve containers
Investigation of reserve sample deterioration
Reserve sample retention time
Written sanitation procedures not followed
Certificates of Testing (Containers, Closures)
Component release checked by 2nd person
Reprocessing procedures lack steps to be taken
Packaging line inspection documentation
In process materials - conformance to written specs
Tentative expiration date
Failing to test for penicillin cross-contamination
Investigations made into any unexplained discrepancy
Weights and measures of components used

Identification of each component or in-process
material
Identity of major equipment and lines used
Dates not included for each significant step
Complaints reviewed by Quality Control Unit
Data secured in course of each test
Investigation of serious, unexpected events
[NDA prod] Fail to submit report in apprvd electronic

format
Interval
Incomplete periodic safety report
Failure of responsible person to report AE (non-RX

Drug)
No label copy submitted with AE report (non-Rx drug)
Contact surfaces
Adverse effects of changes made
Each lot identified and tested
Rep.sample - containers/closures
Master Production and Control Records
Action limits on radiochemical yield

Complete instructions, procedures, specs
Each major production step
Production area & equipment checks
Lab written procedures
Test records complete (general)
Conform to specs prior to release
Final dated signature
When 30 hour rule is exceeded
Rejection of nonconforming product
Labeling and product mix-ups
Written complaint procedures
Documentation of Non-Conforming Product

Investigation
Packaging, labeling - Rx only
Label - For research use
Label - Parenteral drug, sterile
Label - Inactive ingredient, name
Late submission of an ICSR

Incomplete ADE information on ICSR
Vermin, production area
Vermin, adjacent area
Inadequate control, construction adjacent to drug

production
Personnel in aseptic processing, non-sterile gloves
Sterile product air exposure
Personnel contact on container or closure
Dust-collecting overhangs, surrounding area of ISO 5
Location, ISO 5 classified area
Lack of HEPA filter, sterile product area
Unsealed HEPA filter, perimeter
Inadequate filter, final product sterilization
Failure to comply with REMS Medication Guide
Failure to comply with REMS Elements to Assure Safe

Use (ETASU) B
Failure to comply with REMS Implementation System
Outsourcing facility, compounded drug report follow up

Long Description
The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully
followed]. Specifically, ***
There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its
components to meet any of its specifications] whether or not the batch has been already distributed.
Specifically, ***
Laboratory controls do not include the establishment of scientifically sound and appropriate
[specifications] [standards] [sampling plans] [test procedures] designed to assure that [components]
[drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to
appropriate standards of identity, strength, quality and purity. Specifically, ***
There are no written procedures for production and process controls designed to assure that the drug
products have the identity, strength, quality, and purity they purport or are represented to possess.
Specifically, ***
Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent
[malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the
drug product. Specifically, ***
Testing and release of drug product for distribution do not include appropriate laboratory determination
of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient]
prior to release. Specifically, ***
Control procedures are not established which [monitor the output] [validate the performance] of those
manufacturing processes that may be responsible for causing variability in the characteristics of in-
process material and the drug product. Specifically, ***_x000D_
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile

are not [established] [written] [followed]. Specifically, ***
Appropriate controls are not exercised over computers or related systems to assure that changes in
master production and control records or other records are instituted only by authorized personnel.
Specifically, ***
There is no written testing program designed to assess the stability characteristics of drug products.
Specifically, ***
Equipment used in the manufacture, processing, packing or holding of drug products is not [of
appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use]
[cleaning and maintenance]. Specifically, ***
Written procedures are not [established] [followed] for the cleaning and maintenance of equipment,
including utensils, used in the manufacture, processing, packing or holding of a drug product.
Specifically, *** _x000D_
Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not

performed according to a written program designed to assure proper performance. Specifically, ***
Employees are not given training in [the particular operations they perform as part of their function]
[current good manufacturing practices] [written procedures required by current good manufacturing
practice regulations]. Specifically, ***
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Specifically, ***
The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established]
[documented]. Specifically, ***
Batch production and control records [are not prepared for each batch of drug product produced] [do
not include complete information relating to the production and control of each batch]. Specifically, ***
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile

did not include [adequate] validation of the [aseptic] [sterilization] process. Specifically, ***
Written production and process control procedures are not [followed in the execution of production and
process control functions] [documented at the time of performance]. Specifically, ***
Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control

mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***
Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the
[education] [training] [experience] required to perform their assigned functions. Specifically, ***
Laboratory records do not include complete data derived from all tests, examinations and assay
necessary to assure compliance with established specifications and standards. Specifically, , ***
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room]
[equipment] to produce aseptic conditions. Specifically, ***
There is no quality control unit. Specifically, ***
Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its
components to meet specifications] do not [always] include the conclusions and follow-up. Specifically,
***
Procedures describing the handling of all written and oral complaints regarding a drug product are not
[established] [written] [followed]. Specifically, ***
Written procedures for cleaning and maintenance fail to include [assignment of responsibility]
[maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and
materials used] [description in sufficient detail of the methods of disassembling and reassembling
equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or
obliteration of previous batch identification] [instructions for protection of clean equipment from
contamination prior to use] [parameters relevant to the operation]. Specifically, ***
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile
are not [established] [written] [followed]. Specifically, ***
The written stability testing program is not followed. Specifically, ***
Written procedures are not [established] [followed] for evaluations done at least annually and including
provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations
conducted for each drug product]. Specifically, ***
Reports of analysis from component suppliers are accepted in lieu of testing each component for
conformity with all appropriate written specifications, without [performing at least one specific identity
test on each component] [establishing the reliability of the supplier's analyses through appropriate
validation of the supplier's test results at appropriate intervals]. Specifically, ***
The batch production and control records are deficient in that they do not include documentation of the
accomplishment of each significant step in [manufacturing] [processing] [packing] [holding]. Specifically,
***
Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a
batch or any of its components to meet specifications]. Specifically, ***
Laboratory records are deficient in that they do not include a complete record of all data obtained during
testing. Specifically, ***
Reserve samples from representative sample lots or batches of drug products selected by acceptable
statistical procedures are not examined visually at least once a year for evidence of deterioration.
Specifically, ***
Strict control is not exercised over labeling issued for use in drug product labeling operations.
Specifically, ***
Drug products do not bear an expiration date determined by appropriate stability data to assure they
meet applicable standards of identity, strength, quality and purity at the time of use. Specifically, ***
The written stability program for drug products does not include [reliable] [meaningful] [specific] test
methods. Specifically, ***
Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any
of its specifications] did not extend to [other batches of the same drug product] [other drug products
that may have been associated with the specific failure or discrepancy]. Specifically, ***
Procedures describing the handling of written and oral complaints related to drug products are [not
written or followed] [deficiently written or followed]. Specifically, ***
GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that
employees remain familiar with CGMP requirements applicable to them. Specifically, ***
Each batch of drug product required to be free of objectionable microorganisms is not tested through
appropriate laboratory testing. Specifically, ***
Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that
their identity, strength, quality, and purity are not affected. Specifically, ***
Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory
mechanisms] are not [recorded] [justified]. Specifically, ***
Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage]
[handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers]
[closures]. Specifically, ***
The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control
mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit]
[reviewed and approved by the quality control unit]. Specifically, ***
Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not
maintained in a good state of repair. Specifically, ***
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test
results are not appropriately validated at appropriate intervals. Specifically, ***
You produced hazardous drugs without providing adequate [containment] [segregation] [cleaning of
work surfaces] [cleaning of utensils] [cleaning of personnel] to prevent cross-contamination. Specifically,
***
The quality control unit lacks authority to [review production records to assure that no errors have
occurred] [fully investigate errors that have occurred]. Specifically, ***
The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications
impacting on the [identity] [strength] [quality] [purity] of drug products. Specifically, ***
Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically,
***
Written records of major equipment [cleaning] [maintenance] [use] are not included in individual
equipment logs. Specifically, ***
Drug product production and control records, are not [reviewed] [approved] by the quality control unit
to determine compliance with all established, approved written procedures before a batch is released or
distributed. Specifically, ***
Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is
not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Specifically, ***
Determinations of conformance to appropriate written specifications for acceptance are [not made]
[deficient] for drug products. Specifically, ***
The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals
[in accordance with an established written program] [with provisions for remedial action in the event
accuracy and/or precision limits are not met]. Specifically, ***
The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug
product containers] [closures] [in process materials] [packaging material] [labeling] [drug products].
Specifically, ***
Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is
not appropriate for the duties they perform. Specifically, ***
Time limits are not established when appropriate for the completion of each production phase to assure
the quality of the drug product. Specifically, ***
Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine
conformance to such requirements. Specifically, ***
Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained
in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin].
Specifically, ***
Deviations from written production and process control procedures are not [recorded] [justified].
Specifically, ***
The [separate or defined areas] [control systems] necessary to prevent contamination or mix-ups are
deficient. Specifically, ***
There was a failure to handle and store [components] [drug product containers] [closures] at all times in
a manner to prevent contamination. Specifically, ***
Changes to written procedures are not [drafted, reviewed and approved by the appropriate
organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***
Master production and control records lack [complete manufacturing and control instructions] [sampling
and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of
the methods, equipment, and materials used in the cleaning and maintenance operation, and the
methods of disassembly and reassembling equipment as necessary to assure proper cleaning and
maintenance. Specifically, ***_x000D_
Input to and output from [the computer] [related systems of formulas] [records or data] are not checked
for accuracy. Specifically, ***
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality
standards of each drug product to determine the need for changes in specifications or manufacturing or
control procedures. Specifically, ***
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not
written or followed] [deficiently written or followed]. Specifically, ***
Each component is not tested for conformity with all appropriate written specifications for purity,
strength, and quality. Specifically, ***
Procedures describing the warehousing of drug products are not [established] [followed]. Specifically,
***
You did not [establish] [follow] written quality assurance procedures. Specifically,***
You used a non-pharmaceutical grade component in the formulation of a drug product. Specifically, ***
The identity of each component of a drug product is not verified by conducting at least one test to verify
the identity, using specific identity tests if they exist. Specifically, ***
Records associated with drug product [components] [containers] [closures] [labeling] [production]
[control] [distribution] and within the retention period for such records, were not made readily available
for authorized inspection. Specifically, ***
Written records of investigation of a drug complaint do not include [the findings of the investigation] [the
follow-up]. Specifically, ***
Your facility design allowed the influx of poor quality air into a higher classified area. Specifically, ***
Your facilities are not adequate to ensure [the orderly handling of materials and equipment] [the
prevention of mix-ups] [the prevention of contamination of equipment or product by substances,
personnel, or environmental conditions] that could reasonably be expected to have an adverse effect on
product quality. Specifically, ***
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related
to aseptic processing of drug products. Specifically,***
Drug products failing to meet established [standards] [specifications] [quality control criteria] are not
rejected. Specifically, ***
Written procedures are not [established] [followed] that describe the [in-process controls] [tests]
[examinations] to be conducted on appropriate samples of in-process materials of each batch.
Specifically, ***
Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling]
[testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***
Results of stability testing are not used in determining [appropriate storage conditions] [expiration
dates]. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and
cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, ***
Actual yield and percentages of theoretical yield are not determined at the conclusion of each
appropriate phase of [manufacturing] [processing] [packaging] [holding] of the drug product.
Specifically, ***
Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard
surfaces that are easily cleanable. Specifically,***
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency
particulate air filters under positive pressure. Specifically, ***
Drug product component testing is deficient in that at least one specific test to verify the identity of each
component is not performed. Specifically,***
Written procedures are not [established] [followed] for evaluations conducted at least annually to
review records associated with a representative number of batches, whether approved or rejected.
Specifically, ***
The batch production and control records are deficient in that they do not include [complete labeling
control records] [specimen] [copy] of labeling. Specifically, ***
An NDA-Field Alert Report was not submitted within three working days of receipt of information
concerning [bacteriological contamination] [significant chemical, physical, or other change or
deterioration] in a distributed drug product. Specifically, ***
When errors occurred or a production batch or any component of the batch, failed to meet
specifications, you did not [determine the need for an investigation] [conduct an investigation] [take
appropriate corrective actions] when necessary. Specifically, ***
The ISO 5 classified aseptic processing areas had [difficult to clean] [particle-generating] [visibly dirty]
equipment or surface. Specifically, ***
Protective apparel is not worn as necessary to protect drug products from contamination. Specifically,
***
Access to the storage area for labels and labeling materials is not limited to authorized personnel.
Specifically, ***
An adequate number of batches of each drug product are not tested [nor are records of such data
maintained] to determine an appropriate expiration date. Specifically, ***
Laboratory records do not include complete records of any testing and standardization of laboratory
[reference standards] [reagents] [standard solutions]. Specifically, ***
Written procedures are not [drafted, reviewed and approved by the appropriate organizational units]
[reviewed and approved by the quality control unit]. Specifically, ***
Reserve drug product samples are not [appropriately identified] [representative of each lot or batch of
drug product] [retained and stored under conditions consistent with product labeling]. Specifically, ***
Laboratory records do not include the initials or signature of a second person showing that the original
records have been reviewed for [accuracy] [completeness] [compliance with established standards].
Specifically, ***
Your examination and testing of samples did not assure that the drug product and in-process material
conformed to specifications. Specifically, ***
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the
suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations.
Specifically, ***
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control
the aseptic conditions. Specifically, *** _x000D_
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not
[written] [followed]. Specifically, ***
Each lot of [components] [drug product containers] [closures] is not withheld from use until the lot has
been sampled, tested, examined, and released by the quality control unit. Specifically, ***
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of
container. Specifically, ***_x000D_
Procedures for the preparation of master production and control records are not [described in a written
procedure] [followed]. Specifically, ***
Laboratory records do not include complete records of the periodic calibration of laboratory
[instruments] [apparatus] [gauges] [recording devices]. Specifically, ***
The master production and control records are deficient in that they do not include complete
[manufacturing] [control] [instructions] [sampling] [testing] [procedures] [specifications] [special
notations] [precautions]. Specifically, ***
The batch production and control records do not include a statement of the [actual yield] [percentage of
theoretical yield] at appropriate stages of processing for each batch of drug product produced.
Specifically, ***
Master production and control records lack a statement of theoretical yield [including the maximum and
minimum percentages of theoretical yield beyond which investigation is required]. Specifically, ***
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-
ups between [different components] [drug product containers] [closures] [labeling] [in-process
materials] [drug products] and to prevent contamination. Specifically, ***
An NDA-Field Alert Report was not submitted within three working days of receipt of information
concerning a failure of one or more distributed batches of a drug to meet the specifications established
for it in the application. Specifically, ***
Non-microbial contamination was observed in your production area. Specifically, ***
Disinfecting agents and [cleaning pads] [cleaning wipes] used in the ISO 5 classified aseptic processing
areas were not sterile. Specifically, ***
[Equipment was] [Materials or supplies were] not disinfected prior to entering the aseptic processing
areas. Specifically, ***
You did not [implement procedures] [document your activities in accordance with your procedures] to
ensure that all equipment is [cleaned] [suitable for its intended purposes] [properly installed,
maintained, and capable of repeatedly producing valid results] that could reasonably be expected to
adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test
results when improperly used or maintained. Specifically, ***
The quality control unit lacks responsibility for approving or rejecting drug products [manufactured]
[processed] [packed] [held] under contract by another company. Specifically, ***
The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture]

[processing] [packing] [holding] of each drug product. Specifically, ***
Failure to maintain a backup file of data entered into the computer or related system. Specifically, ***
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to
assure that batches of drug products meet [each appropriate specification] [appropriate statistical
quality control criteria] as a condition for their approval and release. Specifically, ***
A written record of the program along with appropriate validation data has not been maintained in
situations where backup data is eliminated by computerization or other automated processes.
Specifically, ***
The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications
was observed. Specifically, ***
You did not retain reserve samples for drug products for one year after the expiration dates of the drug
products. Specifically, ***
The suitability of all testing methods is not verified under actual conditions of use. Specifically, ***
Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to
FDA] of post marketing adverse drug experiences. Specifically, ***
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA
within 15 calendar days of initial receipt of the information. Specifically, ***
Your firm lacks adequate production and process controls to ensure the consistent production of a PET
drug that meets the applicable standards of identity, strength, quality and purity. Specifically,***
Your laboratory analytical methods are not [suitable for their intended use] [sufficiently sensitive]
[sufficiently specific] [sufficiently accurate] [sufficiently reproducible]. Specifically, ***
The labels of your outsourcing facility's drug products are deficient. Specifically,***
You produced highly potent drugs without providing adequate [containment] [segregation] [cleaning of
***
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to
become contaminated. Specifically, ***
Personnel did not [disinfect] [change gloves frequently enough] to prevent contamination. Specifically,
***
Your facility was designed and/or operated in a way that permits poor flow of [personnel] [materials].
Specifically, ***
The flow of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug
products] though the building is not designed to prevent contamination. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of
clean equipment from contamination prior to use. Specifically, ***
Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug
products are not [written] [followed]. Specifically, ***
Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the
appropriate written specifications for identity, strength, quality, and purity. Specifically, ***
The batch production and control records are deficient in that they are not [an accurate reproduction of
the appropriate master production or control record] [checked for accuracy, dated, and signed].
Specifically, ***
The batch production and control records are deficient in that they do not include identification of
persons [performing] [supervising] [checking] each significant step in the operation. Specifically, ***
Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive,
additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product
beyond the official or other established requirements. Specifically, ***
Specific identification tests are not conducted on components that have been accepted based on the
supplier's report of analysis. Specifically, ***
All [compounding and storage containers] [processing lines] [major equipment] used during the
production of a batch of drug product is not properly identified at all times to indicate [contents] [the
phase of processing of the batch]. Specifically, ***
Determinations of conformance to appropriate written specifications for acceptance are [not made]
[deficient] for in-process materials. Specifically, ***
Drug product samples are not [representative of the entire batch] [properly identified]. Specifically, ***
Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through
keeping hard copy or alternate systems. Specifically, ***
Each lot of a [component] [drug product container] [closure] that is liable to microbiological
contamination that is objectionable in view of its intended use is not subjected to microbiological tests
before use. Specifically, ***
A system by which the distribution of each lot of drug product can be readily determined to facilitate its
recall if necessary, has not been established. Specifically, ***
Written specifications for laboratory controls do not include a description of the [sampling] [testing]
procedures used. Specifically, ***
Batch production and control records do not include complete labeling control records, including
specimens or copies of all labeling used for each batch of drug product produced. Specifically, ***
You did not make adequate product evaluation and take remedial action where actionable microbial
contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic
production. Specifically, ***
You did not make adequate product evaluation and take remedial action where actionable microbial
contamination was found to be present in an area adjacent to the ISO 5 classified aseptic processing area
during aseptic production. Specifically, ***
Unsealed, loose ceiling tiles were observed in your cleanroom. Specifically, ***
to the receipt, identification, storage, and withholding from use of [components] [drug product
containers] [closures] [labeling] pending sampling, testing, or examination by the quality control unit
before release for manufacturing or packaging. Specifically, ***
Records of the [calibration checks] [inspections] of automatic, mechanical or electronic equipment,

including computers or related systems are not maintained. Specifically, ***
There is a lack of written procedures describing in sufficient detail the [receipt] [identification] [storage]
[handling] [sampling] [examination] [testing] of labeling and packaging materials. Specifically, ***
Labeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt
and before use in packaging and labeling of a drug product. Specifically, ***
Labels and other labeling materials are not stored separately with suitable identification for each
different drug product, strength, dosage form or quantity of contents. Specifically, ***
Approved [components] [drug product containers] [closures] are not retested or reexamined as
appropriate for identity, strength, quality and purity after [storage for long periods] [exposure to
conditions that might have an adverse effect] with subsequent approval or rejection by the quality
control unit. Specifically, ***
The distribution system is deficient in that each lot of drug product cannot be readily determined to
facilitate its recall if necessary. Specifically, ***
Component testing is deficient in that each component is not tested for conformity with all appropriate
written specifications for purity, strength, and quality. Specifically, ***
Each lot of a [component] [drug product containers] [closures] liable to objectionable microbiological
contamination is deficiently subjected to microbiological tests before use. Specifically, ***
Sampling and testing plans for drug products are not described in written procedures which include the
[method of sampling] [number of units per batch to be tested]. Specifically, ***
The written stability program for drug products does not include [sample size] [test intervals] based on
statistical criteria for each attribute examined to assure valid estimates of stability. Specifically, ***
The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or
initialing] the equipment cleaning and use log. Specifically, ***
Written procedures are lacking for the use of [rodenticides] [insecticides] [fungicides] [fumigating
agents] [cleaning and sanitizing agents] designed to prevent the contamination of [equipment]
[components] [drug product containers] [closures] [packaging, labeling materials] [drug products].
Specifically, ***
A sample which is representative of each lot in each shipment of each active ingredient is not
[appropriately identified] [retained]. Specifically, ***
Examination and testing of samples is not done to assure that in-process materials conform to
specifications. Specifically, ***
Laboratory controls do not include a determination of conformance to [written descriptions of sampling
procedures] [appropriate specifications] for drug products. Specifically, ***
The reserve sample of drug product does not consist of at least twice the quantity necessary to perform
all the required tests of drug product. Specifically, ***
A written record of each complaint is not maintained in a file designated for drug product complaints [at
the facility where the drug product was manufactured, processed or packed] [at a facility other than the
facility in which the drug product was manufactured, processed or packed provided the written records
are readily available for inspection at that other facility]. Specifically, ***
Written procedures describing the handling of all written and oral complaints do not include provisions
for review to determine whether the complaint represents a serious and unexpected adverse drug
experience which is required to be reported to the Food and Drug Administration. Specifically, ***
Each laboratory used to conduct testing of [components] [in-process materials] [finished PET drug
products] does not [have] [follow] written procedures [for the conduct of each test] [for the
documentation of the results]. Specifically, ***
The container labels of your outsourcing facility's drug products are deficient. Specifically,***
You produced beta-lactam drugs without providing adequate [containment] [segregation] [cleaning of
***
Personnel engaged in aseptic processing were observed with [exposed hands] [exposed wrists] [exposed
legs] [exposed hair] [exposed mouth]. Specifically, ***
You had inadequate HEPA filter [coverage] [airflow] over the area to which sterile product was exposed.
Specifically, ***
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were
insufficient to achieve adequate levels of disinfection. Specifically, ***
Adequate lab facilities for testing and approval or rejection of [components] [drug product containers]
[closures] [packaging materials] [in-process materials] [drug products] are not available to the quality
control unit. Specifically, ***
to the holding of rejected [components] [drug product containers] [closures] [labeling] before
disposition. Specifically,***
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing
and processing operations. Specifically, ***
There is insufficient physical or spatial separation from operations and other drug products to prevent
mix-ups and cross-contamination. Specifically, ***
Samples of representative units were not [collected] [visually examined] for correct labeling at the
completion of finishing operations. Specifically, ***
The results of the examination of the packaged and labeled products were not documented in the batch
production or control records. Specifically, ***
Drug product expiration dates do not appear on the labeling in the manner prescribed by regulations.
Specifically, ***
The [number of containers to be sampled] [amount of material taken from each container] is not based
upon appropriate criteria. Specifically, ***
Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic
properties] to assure that they are suitable for their intended use. Specifically, ***
The written stability program for drug products does not describe the storage conditions for samples
retained for testing. Specifically, ***
There is no written assessment of stability of homeopathic drug products based at least on [testing or
examination of the drug product for compatibility of the ingredients] [marketing experience with the
drug product to indicate that there is no degradation of the product for the normal or expected period of
use]. Specifically, ***
The [component] [drug product container] [closure] [labeling] records do not include the [results of tests
or examinations performed] [the conclusions derived from tests or examinations performed].
Specifically, ***
There is no documentation of the examination and review of labels and labeling for conformity with
[established specifications] [the assigning of a lot or control number]. Specifically, ***
The master production and control records for each batch size of drug product are not [prepared, dated,
and signed by one person with a full handwritten signature] [independently checked, dated, and signed
by a second person]. Specifically, ***
Verification of the suitability of the testing methods is deficient in that they are not [performed under
actual conditions of use] [documented on the laboratory records]. Specifically, ***
Complaint procedures are deficient in that they do not include provisions that allow for the review and
determination of an investigation by the quality control unit. Specifically, ***
Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service
towels] [cleanliness]. Specifically, ***
There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing
in sufficient detail the methods, equipment and materials to be used] for sanitation. Specifically, ***
Samples taken to determine conformance to appropriate written specifications for the acceptance of
each lot within each shipment of [components] [drug product containers] [closures] [labeling] are not
[representative] [adequately identified]. Specifically, ***
Samples taken of drug products for determination of conformance to written specifications are not
[representative] [properly identified]. Specifically, ***
Written procedures for sampling and testing plans are not followed for each drug product. Specifically,
***
Batch production and control records for each batch of drug product produced do not include an
accurate reproduction of the appropriate master production or control record which was checked for
accuracy, dated and signed. Specifically, ***_x000D_
Laboratory records do not include [a description of the sample received for testing] [the source or
location from where the sample was obtained] [the quantity of the sample] [the lot number or other
distinctive code of the sample] [the date the sample was taken] [the date the sample was received for
testing]. Specifically, ***
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the
close of the quarter. Specifically, ***
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the
anniversary date of the approval of the application. Specifically, ***
Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to
FDA] of postmarketing adverse drug experiences. Specifically, ***
The minutes of an RDRC meeting did not include the numerical results of votes on protocols involving
use in human subjects. Specifically, ***
The use of sporicidal agents in the [cleanrooms] [ISO 5 classified aseptic processing] area was
[inadequate] [infrequent]. Specifically, ***
Your in-process specifications for sampling and testing of in-process materials and drug products [were
inconsistent with drug product final specifications] [were not derived from previous acceptable process
average and process variability estimates] [were not determined by the application of suitable statistical
procedures]. Specifically, ***
Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug
product lack the [education] [training] [experience] to perform their assigned functions in such a
manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports
or is represented to possess. Specifically, ***
Production personnel were not practicing good sanitation and health habits. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the
equipment for cleanliness immediately before use. Specifically, ***
The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in
facilities separate from those used for other drug products for human use. Specifically, ***
The batch records do not record the distinctive [identification number] [code] [name of equipment] to
identify major equipment to show the specific equipment used in the manufacture of a batch of a drug
product. Specifically, ***
to the quarantine storage of drug products prior to release. Specifically, ***
Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory
controls and operations. Specifically, ***
Aseptic processing areas are deficient regarding [temperature] [humidity] controls. Specifically, ***
The drug product is not identified with a lot or control number that permits the determination of the
history of the manufacture and control of the batch. Specifically, ***
Inspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all
drug products have been removed from previous operations. Specifically, ***
Packaged and labeled products are not examined during finishing operations to provide assurance that
containers and packages in the lot have the correct label. Specifically, ***
Drug product expiration dates are not related to the storage conditions stated on the labeling, as
determined by stability studies. Specifically, ***
Drug products are not quarantined before being released by the quality control unit. Specifically, ***
Each lot in each shipment received was not identified with a distinctive code for each container or
grouping of containers for [components] [drug product containers] [closures]. Specifically, ***
Incoming [components] [drug product containers] [closures] are not stored under quarantine until they
have been tested or examined, as appropriate, and released. Specifically, ***
Establishment of the reliability of the [container] [closure] supplier's report of analyses is deficient in that
the test results are not appropriately validated at appropriate intervals. Specifically, ***
All records of [production] [control] [distribution] [components] [drug product containers] [closures]
[labeling] associated with a batch of drug product were not maintained at least one (1) year after the
expiration date. Specifically, ***
The records for [components] [drug product containers or closures] [labeling] do not include the
[identity and quantity of each shipment of each lot] [name of the supplier] [supplier's lot number]
[receiving code] [date of receipt] [name of the prime manufacturer if different from the supplier]
[location of the prime manufacturer]. Specifically, ***
Records do not include the disposition of rejected [components] [drug product containers] [closures]
[labeling]. Specifically, ***
The batch production and control records are deficient in that they do not include documentation of
sampling performed. Specifically, ***
Distribution records do not contain the [name and strength of the drug product] [description of dosage
form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug
product]. Specifically, ***
Laboratory records are deficient in that they do not include a [description and identification of the
sample received] [quantity] [lot number] [date sample taken] [date sample received for testing].
Specifically, ***
Laboratory records are deficient in that they do not include a statement of the results of tests and how
they compare to the established [specifications] [standards]. Specifically, ***
Laboratory records are deficient in that they do not include the [initials] [signature] of the person
performing the tests and the dates the tests were performed. Specifically, ***
Complaint procedures are deficient in that they do not include provisions that allow for the review to
determine if the complaints represent [serious] [unexpected adverse drug experiences] which are
required to be reported to FDA. Specifically, ***
Adequate lighting is not provided in all areas. Specifically, ***
Adequate ventilation is not provided. Specifically, ***
Air is recirculated to production areas, without adequate measures to control recirculation of dust.
Specifically, ***
In-process specifications are not [consistent with drug product final specifications] [derived from
previous acceptable process average and process variability estimates where possible] [determined by
the application of suitable statistical procedures where appropriate]. Specifically, ***
In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by
the quality control unit [during the production process] [after storage for long periods]. Specifically, ***
Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their
use in manufacturing or processing operations for which they are unsuitable. Specifically, ***
Determinations of conformance to appropriate written specifications for acceptance are deficient in that
they are not made for each lot within each shipment of [components] [drug product containers]
[closures] [labeling] used in the manufacture, processing, packing or holding of drug products.
Specifically, ***
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in
that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions
for remedial action if limits are not met]. Specifically, ***
Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting
established specifications are used. Specifically, ***
Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in
writing] [followed]. Specifically, ***
Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its
status in terms of being quarantined, approved or rejected. Specifically, ***
Containers and closures are not tested for conformance with all appropriate written procedures.
Specifically, ***
Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of
mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of
solutions]. Specifically,***
Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination]
[testing] of packaging and labeling materials are not followed. Specifically, ***
Written distribution procedures are not [established] [followed]. Specifically, ***

Laboratory controls do not include determination of conformance to appropriate written specifications
for the acceptance of each lot within each shipment of [components] [drug product containers]
[closures] [in-process materials] [labeling] [drug products] used in the manufacture, processing, packing,
or holding of drug products. Specifically, ***
The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].
Specifically, ***
Batch production and control records do not include the identification of the persons [performing]
[directly supervising] [checking] each significant step in the operation, for each batch of drug product
produced. Specifically, ***
Batch production and control records do not include [in-process] [laboratory control] results for each
batch of drug product produced. Specifically, ***
The written record did not include the [reason an investigation was found not to be necessary] [name of
the responsible person making the determination not to conduct an investigation] when an investigation
into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications]
was not conducted. Specifically, ***
Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included
in a periodic safety report. Specifically, ***
A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy of
the published article. Specifically, ***
You failed to maintain for a period of 10 years records of all adverse drug experiences known to you,
including raw data and any correspondence. Specifically, ***
An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval
of the application] to the FDA division responsible for reviewing the application. Specifically, ***
You lack [a sufficient number of] personnel with the necessary [education] [background] [training]
[experience] to perform their assigned functions. Specifically, ***
You did not have written production and process control procedures to [ensure] [document] that [all key
process parameters are controlled] [any deviations from the procedures are justified]. Specifically,***
Your [identity] [purity] [quality] of [reagents] [solutions] [supplies] used in your testing procedures are
not adequately controlled. Specifically, ***
All equipment used to perform the testing is not [suitable for its intended purposes] [capable of
producing valid results]. Specifically,***
Laboratory test records did not contain a complete record of all data obtained in the course of each test,
including [the date and time the test was conducted] [all graphs, charts, and spectra from laboratory
instrumentation, properly identified to show the specific component, in-process material, or drug
product for each lot tested]. Specifically, ***
Laboratory test records did not contain the initials or signature of the person performing the test.
Specifically,***
You did not take [appropriate] action to correct any identified problems to prevent recurrence of a
nonconforming product or other quality problem. Specifically,***
The RDRC Chairman did not sign all [applications] [minutes] [reports] of the committee. Specifically, ***
Personnel moved rapidly in the vicinity of [open sterile units] [instruments], which disrupted the airflow
and increased the risk of bringing lesser quality air into the ISO 5 classified aseptic processing area.
Specifically, ***
Personnel [conducted aseptic manipulations] [placed equipment/supplies] in an area that blocked the
movement of first pass air around an open unit, either before or after it was filled with sterile product.
Specifically, ***
[Non-sterilized] [Non-depyrogenated] equipment was used in sterile drug production. Specifically, ***
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing
area. Specifically, ***
Your master production and control records for each drug product were not [prepared, dated, and signed
by one person] [independently checked, dated, and signed by a second person]. Specifically, ***
The preparation of your master production and control records was not [described in a written
procedure] [followed in accordance with your written procedure]. Specifically, ***
Unauthorized personnel have access to enter areas of the buildings and facilities designated as limited
access areas. Specifically, ***
Each component is not added to a batch by one person and verified by a second person. Specifically, ***
to the storage of released [components] [drug product containers] [closures] [labeling]. Specifically,
***_x000D_
to the storage of in-process materials. Specifically, ***
to the storage of drug products after release. Specifically,***
Deviations from production time limits [are not justified] [are not documented] [compromise the quality
of the drug product]. Specifically, ***
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will
conform with all established standards, specifications, and characteristics are not [written] [followed].
Specifically, ***
Obsolete or outdated labels, labeling and packaging materials are not destroyed. Specifically, ***
Labeling materials issued for a batch were not carefully examined for identity and conformity to the
labeling specified in the master or batch production records. Specifically, ***
Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and
returned, were not [evaluated] [investigated]. Specifically, ***
Filled drug product containers which are set aside and held in an unlabeled condition are not [identified]
[handled] to preclude mislabeling of individual containers, lots or portions of lots. Specifically, ***
Examination of packaging and labeling materials for suitability and correctness before packaging
operations is [not performed] [not documented in the batch production records]. Specifically, ***
Each container or grouping of containers of [components] [drug product containers] [closures] is not
examined visually upon receipt and before acceptance for [appropriate labeling as to contents]
[container damage] [broken seals] [contamination]. Specifically, ***
Representative samples are not taken of each shipment of each lot of [components] [drug product
containers] [closures] for testing or examination. Specifically, ***
The containers of components, or drug product containers or closures which are sampled are not
opened in a manner to prevent [contamination of their contents] [contamination of other components]
[contamination of other drug product containers] [contamination of other closures]. Specifically, ***
Drug product container and closure test procedures are deficient in that [containers] [closures] are not
tested for conformance in accordance with appropriate written procedures. Specifically, ***
Container closure systems do not provide adequate protection against foreseeable external factors in
storage and use that can cause deterioration or contamination of the drug product. Specifically, ***
Records for all [production] [control] [distribution] [components] [drug product containers] [closures]
[labeling] associated with a batch of OTC drug product exempt from expiration dating were not
maintained for 3 years after distribution of the last lot of drug product incorporating the component or
using the container, closure, or labeling. Specifically, ***
Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written]
[followed]. Specifically, ***
The procedures for the annual quality standards record evaluation are deficient in that they do not
address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation]
records for each drug product. Specifically, ***
Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].
Specifically, ***
The entries in the equipment cleaning and use logs are not in chronological order. Specifically, ***
The batch production and control records are deficient in that they do not include the identity of major
[equipment] [lines] used. Specifically, ***
The batch production and control records are deficient in that they do not include specific identification
of each [batch of component] [in-process material] used. Specifically, ***
The batch production and control records are deficient in that they do not include [weights] [measures]
of components used in the process. Specifically, ***
The batch production and control records are deficient in that they do not include documentation of the
inspection of the [packaging] [labeling] area before and after use. Specifically, ***
The batch production and control records are deficient in that they do not include a statement of the
[actual yield] [percentage of theoretical yield]. Specifically, ***
Drug products that have been subjected to improper storage conditions were salvaged and returned to
the marketplace without further evidence or inspection. Specifically, ***
Records for salvaged drug products do not include [name] [lot number] [disposition]. Specifically, ***
The master production and control records are deficient in that they do not include a complete list of
components designated by [name] [code] sufficiently specific to indicate any special characteristic.
Specifically, ***
The master production and control records are deficient in that they do not include a statement of
theoretical yield and [minimum] [maximum] [yield percentages]. Specifically, ***
Laboratory records are deficient in that they do not include a statement of the [weight] [measure] of the
sample used for testing. Specifically, ***
Laboratory records are deficient in that they do not include all calculations performed during testing.
Specifically, ***
Laboratory records are deficient in that they do not include the [initials] [signature] of the second person
reviewing the record for accuracy. Specifically, ***
Complaint procedures are deficient in that written complaint files are not maintained at the
manufacturing site nor were they readily available from their off-site location. Specifically, ***
Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].
Specifically, ***
The production area air supply lacks an appropriate air filtration system. Specifically, ***
The plumbing system contains defects that could contribute to the contamination of drug products.
Specifically, ***
Drains are not [of adequate size] [provided with an air break or other mechanical device to prevent back-
siphonage where connected directly with a sewer]. Specifically, ***
Washing and toilet facilities are not [provided] [easily accessible to working areas]. Specifically, ***
Sampling procedures are deficient regarding compositing for testing of samples collected from the top,
middle, and bottom of the component container. Specifically, ***
Rejected [components] [drug product containers] [closures] are not controlled under a quarantine
system designed to prevent their use in manufacturing or processing operations for which they are
unsuitable. Specifically, ***
Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate].
Specifically, ***
Component containers dispensed to manufacturing are deficiently examined by a second person in that
the component is not released by the quality control unit. Specifically, ***
Each component is not added to the batch by one person and verified by a second person.. Specifically,
***
The in-process control procedures were deficient in that it did not include an examination of [tablet]
[capsule] weight variation. Specifically, ***
The specifications for components, drug product containers or closures and labeling are deficient in that
they do not include a description of the [sampling plan] [testing procedures]. Specifically, ***
The specifications for in-process materials are deficient in that they do not include a description of the
[sampling plan] [testing procedures] for in-process materials. Specifically, ***
The specifications for drug products are deficient in that they do not include a description of the
[sampling plan] [testing procedures] for drug products. Specifically, ***
Drug product reserve samples are not stored in [the same immediate container-closure system as the
marketed product] [an immediate container-closure system that has essentially the same characteristics
as the marketed product]. Specifically, ***
Evidence of reserve drug product sample deterioration was not [investigated] [recorded and maintained
with other stability data]. Specifically, ***_x000D_
The retention period for drug product reserve samples (except those described in 211.170(b)(2) and (3))
is deficient in that they are not retained for one year after the expiration date of the drug product.
Specifically, ***
Written procedures for sanitation are not followed. Specifically, ***
Certificates of testing of [containers] [closures] are accepted in lieu of testing without [a visual
identification] [establishing the reliability of the supplier's test results through appropriate validation of
the test results at appropriate intervals]. Specifically, ***
Each container of component dispensed to manufacturing is not examined by a second person to assure
that [the component was released by the quality control unit] [the weight or measure is correct as stated
in the batch records] [the containers are properly identified]. Specifically, ***
Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with
all established standards, specifications, and characteristics. Specifically, ***
Results of inspection of packaging and labeling facilities are not documented in the batch production
records. Specifically, ***
Laboratory controls do not include a determination of conformance to written specifications for in-
process materials. Specifically, ***
Where data from accelerated studies was used to project a tentative expiration date beyond a date
supported by actual shelf life studies, there were no [stability studies] [drug product testing at
appropriate intervals] conducted until the tentative expiration date was verified or the appropriate
expiration date determined. Specifically, ***
Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility
existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin.
Specifically, ***
Batch production and control records do not include the results of any investigation made into any
unexplained discrepancy, whether or not the batch of drug product had already been distributed.
Specifically, ***
Batch production and control records do not include the weights and measures of components used in
the course of processing each batch of drug product produced. Specifically, ***
Batch production and control records do not include the specific identification of each batch of
[component] [in-process material] used for each batch of drug product produced. Specifically, ***
Batch production and control records do not include the identity of individual major [equipment] [lines]
used for each batch of drug product produced. Specifically, ***
Batch production and control records do not include dates of each significant step in the [manufacture]
[processing] [packing] [holding] of the batch for each batch of drug product produced. Specifically, ***
Written procedures describing the handling of complaints do not include provisions for [review by the
quality control unit of any complaint involving the possible failure of a drug product to meet any of its
specifications] [a determination as to the need for an investigation of any unexplained discrepancy]
[explaining the reasons for the failure of the batch or any of its components to meet specifications].
Specifically, ***
Laboratory records do not include a complete record of all data secured in the course of each test,
including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the
[specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product
tested]. Specifically, ***
Serious, unexpected adverse drug experiences have not been [promptly] investigated. Specifically, ***
You did not submit adverse drug experience information in electronic format. Specifically, ***
Periodic reports of non-alert adverse drug experiences have not been submitted [quarterly for an
application which was approved less than three years ago] [yearly for an application which was approved
three or more years ago]. Specifically, ***
You failed to submit a periodic report containing [a narrative summary and analysis of the ADE
information for the reporting interval in the report] [an analysis of the post marketing 15-day Alert
reports submitted during the reporting interval] [a history of actions taken since the last report because
of adverse drug experiences] [an index with a line listing of your patient identification code and adverse
reaction term(s) for all ICSRs you submitted for the reporting interval]. Specifically, ***
Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to
the Secretary of HHS. Specifically, ***
Copies of labels from on or within the retail package of a non-prescription drug did not accompany
serious drug event report. Specifically, ***
Your equipment is not [constructed] [maintained] so that surfaces that contact [components] [in-process
materials] [PET drugs] are not reactive, additive, or absorptive so as to alter the quality of the PET drugs.
Specifically,***
You did not demonstrate that any change does not adversely affect the [identity] [strength] [quality]
[purity] of your PET drug. Specifically,***
Each lot of [components] [containers] [closures] is not [uniquely identified] [tested or examined to
determine compliance with your specifications]. Specifically,***
You did not examine a representative sample of each lot of [containers] [closures] for conformity to
written specifications. Specifically,***
You did not have master production and control records that document all steps in the PET drug
production process. Specifically,***
Your master production and control records did not include a statement of action limits on radiochemical
yield. Specifically,***
Your master production and control records did not include complete [production and control
instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be
followed]. Specifically,***
Your batch production record does not include each major production step (obtained from the approved
appropriate master production and control record). Specifically, ***
Your [production area] [equipment in the production area] was not checked to ensure [cleanliness]
[suitability] immediately before use. Specifically,***
Laboratory written procedures are not [established] [followed] to ensure that the lab equipment is
routinely [calibrated] [inspected] [checked] [maintained]. Specifically,***
Each laboratory used to perform tests related to the production of a PET drug did not keep complete
records of all tests performed to ensure compliance with established specifications and standards,
including examinations and assays. Specifically,***
You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug
product conforms to specifications before final release. Specifically, ***
You did not [establish] [follow] procedures to ensure that each batch or sub-batch of a PET drug was not
given final release until a designated qualified individual authorized the final release by dated signature.
Specifically, ***
A sample for sterility testing was held longer than 30 hours, but you did not demonstrate that the longer
period did not adversely affect the sample and that the test results obtained were equivalent to test
results that would have been obtained if the test had been started within the 30 hour period.
Specifically,***
You did not reject the batch of a PET drug product that did not conform to specifications. Specifically,***
Labeling and packaging operations for PET drug products were not controlled to prevent labeling and
product mix-ups. Specifically,***
You have not [developed] [followed] written procedures for the receipt and handling of all complaints
concerning the quality or purity of, or possible adverse reactions to, a PET drug product. Specifically,***
You did not document [the results of the investigation] [what happened to the rejected PET drug
product] for a PET drug product that did not meet specifications. Specifically, ***
The label of a radioactive drug prepared, packaged, distributed, and primarily intended for use in the
RDRC research project did not bear the statement "Rx only". Specifically, ***
RDRC research project did not bear a statement that the drug is to be administered in compliance with
radioactive drug research use. Specifically, ***
The label of a radioactive parenteral drug prepared, packaged, distributed, and primarily intended for
use in the RDRC research project did not bear a statement as to whether the contents are sterile.
Specifically, ***
RDRC research project and intended for other than oral use did not bear the name of an inactive
ingredient. Specifically, ***
You failed to submit an ICSR for the reporting period [within 30 days of the close of the quarter] [within
60 days of the anniversary date of the approval of the application]. Specifically, ***
You submitted an ICSR reporting adverse drug experience information that failed to include the
[outcome attributed to adverse drug experience] [date of adverse drug experience] [date of ICSR
submission] [description of adverse drug experience including a concise medical narrative] [adverse drug
experience term(s)] [description of relevant tests including dates and laboratory data] [other relevant
patient history including preexisting medical conditions]. Specifically, ***
Vermin was observed in your production area. Specifically, ***
Vermin was observed in an area immediately adjacent to your production area. Specifically, ***
Your firm produced drugs while construction was underway in an adjacent area without adequate
controls to prevent contamination of the production environment and product. Specifically, ***
Personnel engaged in aseptic processing were observed wearing non-sterile gloves. Specifically, ***
[Inadequately protected] [Un-protected] product intended to be sterile was exposed to lower than ISO 5
classified aseptic processing area quality air. Specifically, ***
Personnel [used a non-sterile tool on] [manually contacted the inner surface of] the container or closure.
Specifically, ***
The [ISO 5 classified aseptic processing areas] [segregated production areas surrounding the ISO 5
classified aseptic processing area] contained dust-collecting overhangs without adequate and frequent
cleaning. Specifically, ***
The ISO 5 classified aseptic processing area was located within a non-classified room (segregated
production area). Specifically, ***
You did not have a HEPA filter over the area to which sterile product was exposed. Specifically, ***
HEPA filters were not sealed around each perimeter to the support frame. Specifically, ***
The filter intended to render final product sterile [was not adequate to accomplish sterilization] [was not
pharmaceutical grade]. Specifically, ***
An application holder did not dispense the Medication Guide, as required by your approved REMS
Medication Guide. Specifically, ***
An application holder did not [ensure pharmacies that dispense the drug are specially certified] [ensure
mechanisms are in place that allow pharmacies the ability to complete the certification process]
[maintain a validated, secure database of certified pharmacies] [identify and address non-compliant
certified pharmacies], as required by your approved REMS Element to Assure Safe Use (ETASU) B.
Specifically, ***
An application holder did not [ensure wholesalers / distributors who distribute the drug are authorized
to distribute the drug] [comply with the audit plan and schedule described in the REMS] [identify and
address non-compliant authorized wholesalers / distributors] [maintain a Support / Call Center or a
REMS Program website] [maintain the drug distribution and dispensing records to ensure restricted
distribution], as required by your approved REMS Implementation System. Specifically, ***
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the
previous six month period. Specifically, ***
Frequency
215
167
145
108
99
90
81
79
73
67
66
65
63
53
52
49
46
42
40
40
39
38
37
36
34
32
31
30
29
29
28
27
26
24
24
22
22
22
22
22
21
21
21
20
19
18
18
17
16
15
15
15
15
15
15
15
15
14
14
14
14
14
14
13
13
13
13
12
12
12
12
12
12
12
12
11
11
11
11
11
10
10
10
10
10
9
9
7
7
6
6
5
5
4
4
3
3
3
3
2
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
Foods 18254 21 CFR 1.502(a)
Foods 18138 21 CFR 117.10
Foods 18145 21 CFR 117.35(c)
Foods 1524 21 CFR 123.11(b)
Foods 18141 21 CFR 117.35(a)
Foods 905 21 CFR 123.6(b)
Foods 18140 21 CFR 117.20(b)
Foods 18161 21 CFR 117.80(c)
Foods 18149 21 CFR 117.40
Foods 19030 21 CFR 117.130(a)(1)
Foods 18148 21 CFR 117.37
Foods 18142 21 CFR 117.35(a)
Foods 959 21 CFR 123.6(c)(1)
Foods 961 21 CFR 123.6(c)(3)
Foods 960 21 CFR 123.6(c)(2)
Foods 18146 21 CFR 117.35(d)
Foods 18398 21 CFR 117.4
Foods 19027 21 CFR 117.126(a)(1)
Foods 963 21 CFR 123.6(c)(5)
Foods 15839 21 CFR 111.70(e)

Foods 904 21 CFR 123.6(b)
Foods 6004 21 CFR 123.6(c)(4)
Foods 1525 21 CFR 123.11(c)
Foods 18165 21 CFR 117.93
Foods 945 21 CFR 123.12(a)(2)
Foods 15927 21 CFR 111.103
Foods 908 21 CFR 123.6(d)
Foods 18153 21 CFR 117.80(a)
Foods 19066 21 CFR 117.165(b)
Foods 18139 21 CFR 117.20(a)
Foods 19033 21 CFR 117.135(a)(1)
Foods 19059 21 CFR 117.145(a)
Foods 18163 21 CFR 117.80(c)(8)
Foods 15532 21 CFR 111.255(b)
Foods 18147 21 CFR 117.35(e)
Foods 4470 21 CFR 108.25(c)(2)
Foods 6008 21 CFR 123.8(a)(3)
Foods 15641 21 CFR 111.453

Foods 18143 21 CFR 117.35(b)(1)
Foods 21276 21 CFR 117.405(a)(1)

Foods 18562 21 CFR 1.512(b)(2)
Foods 19058 21 CFR 117.135(c)(3)
Foods 15861 21 CFR 111.75(a)(2)(ii)(A)
Foods 6021 21 CFR 123.10
Foods 19036 21 CFR 117.145(a)
Foods 15829 21 CFR 111.70(b)(1)
Foods 15797 21 CFR 111.553
Foods 15830 21 CFR 111.70(b)(2)
Foods 15858 21 CFR 111.75(a)(1)(i)
Foods 18144 21 CFR 117.35(b)(2)
Foods 6005 21 CFR 123.6(c)(6)
Foods 15762 21 CFR 111.205(a)
Foods 18151 21 CFR 117.40(f)
Foods 933 21 CFR 123.8(a)(2)(ii)
Foods 19049 21 CFR 117.145(a)
Foods 15869 21 CFR 111.75(c)
Foods 19044 21 CFR 117.165(b)
Foods 3080 21 CFR 114.83
Foods 18154 21 CFR 117.80(a)(2)
Foods 3071 21 CFR 114.80(a)(1)
Foods 6018 21 CFR 123.7(a)

Foods 9931 21 CFR 120.6(b)
Foods 3086 21 CFR 114.100(b)
Foods 16042 21 CFR 111.503
Foods 901 21 CFR 123.6(a)
Foods 3078 21 CFR 114.80(b)
Foods 6001 21 CFR 123.11(b)
Foods 18160 21 CFR 117.80(b)(8)
Foods 18283 21 CFR 1.505(b)
Foods 19039 21 CFR 117.150(a)(1)
Foods 19048 21 CFR 117.135(c)(2)
Foods 15825 21 CFR 111.65
Foods 15763 21 CFR 111.205(a)
Foods 15897 21 CFR 111.83(a)
Foods 18290 21 CFR 1.506(a)(1)
Foods 4464 21 CFR 108.25(c)(1)
Foods 15831 21 CFR 111.70(b)(3)
Foods 18262 21 CFR 1.504(a)
Foods 19031 21 CFR 117.130(a)(2)

Foods 6015 21 CFR 123.6(c)(6)
Foods 6020 21 CFR 123.9(a)
Foods 1560 21 CFR 110.35(c)
Foods 15748 21 CFR 111.210(f)
Foods 15838 21 CFR 111.70(d)
Foods 18281 21 CFR 1.505(a)(2)
Foods 19060 21 CFR 117.145(b)
Foods 906 21 CFR 123.6(b)
Foods 3877 21 CFR 113.60(c)
Foods 12742 21 CFR 120.8(a)
Foods 18397 21 CFR 117.4
Foods 3062 21 CFR 114.10
Foods 15531 21 CFR 111.255(a)
Foods 15819 21 CFR 111.55
Foods 15840 21 CFR 111.70(e)
Foods 18293 21 CFR 1.506(b)
Foods 19034 21 CFR 117.135(b)
Foods 21279 21 CFR 117.415(a)(2)
Foods 1422 21 CFR 110.20(b)(4)

Foods 4511 21 CFR 108.25(f)
Foods 9954 21 CFR 120.11(a)(1)(iv)
Foods 15932 21 CFR 111.105(a)
Foods 19045 21 CFR 117.160(a)
Foods 6006 21 CFR 123.6(c)(7)
Foods 18155 21 CFR 117.80(a)(5)
Foods 4475 21 CFR 108.25(c)(3)(i)
Foods 12747 21 CFR 120.8(b)(3)
Foods 15828 21 CFR 111.70(a)
Foods 15933 21 CFR 111.105(b)
Foods 18162 21 CFR 117.80(c)
Foods 19061 21 CFR 117.145(c)(1)

Foods 1306 21 CFR 110.20(b)(7)
Foods 1552 21 CFR 110.35(a)
Foods 4479 21 CFR 108.25(e)
Foods 4524 21 CFR 108.35(g)
Foods 6007 21 CFR 123.9(a)
Foods 6017 21 CFR 123.7(c)

Foods 6019 21 CFR 123.8(a)(2)
Foods 9961 21 CFR 120.24(a)
Foods 15659 21 CFR 111.475(b)(1)
Foods 15796 21 CFR 111.430(b)
Foods 16118 21 CFR 118.4
Foods 18150 21 CFR 117.40(e)
Foods 931 21 CFR 123.8(d)
Foods 3067 21 CFR 114.80(a)
Foods 4519 21 CFR 108.35(c)(3)(i)
Foods 12748 21 CFR 120.8(b)(5)
Foods 16057 21 CFR 111.535(b)(1)
Foods 16152 21 CFR 118.5(a)
Foods 18559 21 CFR 1.512(b)(1)(i)(A)
Foods 19040 21 CFR 117.150(a)(2)
Foods 19084 21 CFR 117.305
Foods 21151 21 CFR 112.145(a)
Foods 21165 21 CFR 112.147(a)
Foods 1316 21 CFR 113.87(c)
Foods 3085 21 CFR 114.100(a)

Foods 9955 21 CFR 120.11(a)(1)
Foods 12746 21 CFR 120.8(b)(2)
Foods 15526 21 CFR 111.30(c)
Foods 15759 21 CFR 111.205(b)(2)
Foods 15871 21 CFR 111.75(c)(2)
Foods 15885 21 CFR 111.77(a)
Foods 16070 21 CFR 111.35(b)(2)
Foods 19037 21 CFR 117.145(b)
Foods 950 21 CFR 123.12(d)
Foods 3075 21 CFR 114.80(a)(4)
Foods 6010 21 CFR 123.8(a)(3)(i)
Foods 9932 21 CFR 120.6(a)
Foods 9939 21 CFR 120.7(c)
Foods 15404 21 CFR 111.12(c)
Foods 15494 21 CFR 111.25(c)
Foods 15790 21 CFR 111.403
Foods 15843 21 CFR 111.70(g)
Foods 15928 21 CFR 111.103
Foods 16120 21 CFR 118.4

Foods 16135 21 CFR 118.4(b)(4)
Foods 19035 21 CFR 117.135(c)(1)
Foods 19052 21 CFR 117.150(a)(1)
Foods 19078 21 CFR 117.139(a)
Foods 918 21 CFR 123.8(a)
Foods 932 21 CFR 123.7(d)
Foods 9943 21 CFR 120.8(a)
Foods 12745 21 CFR 120.8(b)(1)
Foods 15402 21 CFR 111.12
Foods 15410 21 CFR 111.14(b)(2)
Foods 15496 21 CFR 111.27(b)
Foods 15543 21 CFR 111.260(c)
Foods 15642 21 CFR 111.455(a)
Foods 15732 21 CFR 111.365(a)
Foods 15809 21 CFR 111.570(b)(1)
Foods 15864 21 CFR 111.75(a)(2)(ii)(C)
Foods 15977 21 CFR 111.123(a)(1)
Foods 16089 FDCA 417(d)(1)(A)
Foods 16142 21 CFR 118.4(c)(3)
Foods 18263 21 CFR 1.504(b)(1)
Foods 19032 21 CFR 117.136(a)(2)(i)

Foods 19038 21 CFR 117.145(c)(1)
Foods 19043 21 CFR 117.165(a)(4)
Foods 19062 21 CFR 117.150(a)(1)
Foods 19064 21 CFR 117.150(d)
Foods 19065 21 CFR 117.165(a)(4)
Foods 21147 21 CFR 112.144(a)
Foods 21278 21 CFR 117.415(a)(1)
Foods 21280 21 CFR 117.420(b)
Foods 21400 21 CFR 117.80(b)(4)
Foods 913 21 CFR 123.8(a)(1)
Foods 9936 21 CFR 120.7(a)
Foods 12743 21 CFR 120.8(b)(4)
Foods 12749 21 CFR 120.8(b)(6)
Foods 12755 21 CFR 120.11(a)(1)(iv)
Foods 15442 21 CFR 111.15(b)(1)
Foods 15453 21 CFR 111.16
Foods 15481 21 CFR 111.23(b)
Foods 15492 21 CFR 111.25(a)
Foods 15545 21 CFR 111.260(e)
Foods 15645 21 CFR 111.455(c)
Foods 15817 21 CFR 111.570(b)(2)(ii)(F)

Foods 15872 21 CFR 111.75(c)(3)
Foods 15898 21 CFR 111.83(b)(1)
Foods 15930 21 CFR 111.105
Foods 15983 21 CFR 111.123(a)(7)
Foods 15986 21 CFR 111.123(b)(2)
Foods 16058 21 CFR 111.535(b)(2)
Foods 16071 21 CFR 111.35(b)(3)
Foods 16138 21 CFR 118.4(c)(1)
Foods 16140 21 CFR 118.4(c)(2)
Foods 16195 21 CFR 118.10(a)(3)(iv)
Foods 18159 21 CFR 117.80(b)(6)
Foods 18572 21 CFR 1.512(b)(3)(i)
Foods 19041 21 CFR 117.150(b)(2)
Foods 19042 21 CFR 117.150(d)

Foods 19051 21 CFR 117.145(c)(1)
Foods 21035 21 CFR 112.22(c)
Foods 21148 21 CFR 112.144(b)(1)
Foods 929 21 CFR 123.8(b)
Foods 990 21 CFR 110.10(b)(3)
Foods 1331 21 CFR 113.100(a)(1)

Foods 1427 21 CFR 110.20(b)(5)
Foods 1554 21 CFR 110.35(a)
Foods 1642 21 CFR 113.100(b)
Foods 2275 21 CFR 129.80(g)(2)
Foods 4179 21 CFR 113.83
Foods 6002 21 CFR 123.11(b)
Foods 6022 21 CFR 123.12(c)
Foods 9935 21 CFR 120.7(a)
Foods 9941 21 CFR 120.8(a)
Foods 9947 21 CFR 120.11(b)
Foods 12734 21 CFR 120.12(a)
Foods 12750 21 CFR 120.8(b)(6)
Foods 15351 FDCA 761(b)(1)
Foods 15454 21 CFR 111.16
Foods 15499 21 CFR 111.27(a)
Foods 15546 21 CFR 111.260(f)
Foods 15698 21 CFR 111.320(a)

Foods 15747 21 CFR 111.210(g)
Foods 15761 21 CFR 111.205(b)(1)
Foods 15799 21 CFR 111.560(a)(1)
Foods 15862 21 CFR 111.75(a)(2)
Foods 15863 21 CFR 111.75(a)(2)(ii)(B)
Foods 15921 21 CFR 111.95(b)(2)
Foods 15978 21 CFR 111.123(a)(2)
Foods 16141 21 CFR 118.4(c)(2)
Foods 16192 21 CFR 118.10(a)(3)(i)
Foods 16204 21 CFR 118.10(b)(2)
Foods 18272 21 CFR 1.504(d)
Foods 18295 21 CFR 1.506(d)(1)(i)
Foods 18399 21 CFR 117.305
Foods 19028 21 CFR 117.126(a)(2)
Foods 19047 21 CFR 117.155(b)
Foods 19063 21 CFR 117.150(a)(2)
Foods 19076 21 CFR 117.165(b)
Foods 21256 21 CFR 1.502(a)
Foods 21273 21 CFR 117.206(a)
Foods 899 21 CFR 123.16
Foods 1045 21 CFR 113.10

Foods 1287 21 CFR 110.20(a)(1)
Foods 1293 21 CFR 110.20(b)(2)
Foods 1471 21 CFR 113.83
Foods 1597 21 CFR 110.37(b)(3)
Foods 1761 21 CFR 129.80(a)
Foods 3072 21 CFR 114.80(a)(1)
Foods 3073 21 CFR 114.80(a)(2)
Foods 3082 21 CFR 114.89
Foods 3088 21 CFR 114.100(b)
Foods 4515 21 CFR 108.35(c)(2)
Foods 6016 21 CFR 123.6(c)(7)
Foods 9928 21 CFR 120.12(b)
Foods 9958 21 CFR 120.12(c)
Foods 9981 21 CFR 120.12(b)(4)
Foods 12744 21 CFR 120.8(b)(4)
Foods 15425 21 CFR 111.15(i)
Foods 15429 21 CFR 111.15(k)

Foods 15434 21 CFR 111.15(d)(2)
Foods 15498 21 CFR 111.27(d)
Foods 15511 21 CFR 111.27(d)
Foods 15554 21 CFR 111.260(j)(2)(ii)
Foods 15570 21 CFR 111.153
Foods 15578 21 CFR 111.155(c)
Foods 15723 21 CFR 111.365(i)
Foods 15786 21 CFR 111.410(b)
Foods 15800 21 CFR 111.560(a)(2)
Foods 15801 21 CFR 111.560(b)
Foods 15832 21 CFR 111.70(c)(1)
Foods 15842 21 CFR 111.70(f)
Foods 15853 21 CFR 111.73
Foods 15865 21 CFR 111.75(a)(2)(ii)(D)
Foods 15870 21 CFR 111.75(c)(1)
Foods 15882 21 CFR 111.75(h)(2)
Foods 15951 21 CFR 111.110(c)
Foods 16013 21 CFR 111.140(b)(1)
Foods 16014 21 CFR 111.140(b)(1)
Foods 16193 21 CFR 118.10(a)(3)(ii)

Foods 18166 21 CFR 117.95(a)
Foods 19050 21 CFR 117.145(b)
Foods 19056 21 CFR 117.165(b)
Foods 19068 21 CFR 117.135(c)(6)
Foods 19080 21 CFR 117.170
Foods 21101 21 CFR 112.123(d)(1)
Foods 21277 21 CFR 117.405(c)
Foods 21478 21 CFR 117.201(a)(2)(i)
Foods 1007 21 CFR 110.10(b)(9)
Foods 1173 21 CFR 110.40(f)
Foods 1300 21 CFR 113.81(c)
Foods 1330 21 CFR 113.100(a)
Foods 1351 21 CFR 129.35(a)(3)(i)
Foods 1453 21 CFR 129.40(a)(1)
Foods 1553 21 CFR 110.35(a)
Foods 1571 21 CFR 110.35(d)(5)
Foods 1615 21 CFR 110.93
Foods 1695 21 CFR 110.80(b)(2)
Foods 1735 21 CFR 113.40(a)(2)(iii)
Foods 2274 21 CFR 129.80(g)(1)

Foods 3652 21 CFR 110.37(e)(1)
Foods 3658 21 CFR 110.37(e)(2)
Foods 4062 21 CFR 113.100(a)
Foods 4181 21 CFR 113.89
Foods 9919 21 CFR 120.10(a)
Foods 9930 21 CFR 120.6(c)
Foods 9986 21 CFR 120.24(c)
Foods 12709 21 CFR 129.80(c)
Foods 12732 21 CFR 120.10(a)
Foods 15302 21 CFR 120.11(a)(2)
Foods 15388 21 CFR 111.10(b)
Foods 15396 21 CFR 111.10(b)(6)
Foods 15401 21 CFR 111.12(b)
Foods 15409 21 CFR 111.14(b)(1)
Foods 15478 21 CFR 111.20(f)
Foods 15480 21 CFR 111.20(h)
Foods 15506 21 CFR 111.27(a)(4)
Foods 15533 21 CFR 111.255(c)
Foods 15535 21 CFR 111.255(d)
Foods 15547 21 CFR 111.260(g)

Foods 15557 21 CFR 111.260(k)
Foods 15560 21 CFR 111.260(k)(2)
Foods 15562 21 CFR 111.260(l)(1)
Foods 15572 21 CFR 111.153
Foods 15582 21 CFR 111.155(e)
Foods 15583 21 CFR 111.155(d)(1)
Foods 15584 21 CFR 111.155(d)(1)
Foods 15598 21 CFR 111.160(d)(1)
Foods 15620 21 CFR 111.180(b)(1)
Foods 15660 21 CFR 111.475(b)(2)
Foods 15662 21 CFR 111.303
Foods 15702 21 CFR 111.320(b)
Foods 15708 21 CFR 111.325(a)
Foods 15733 21 CFR 111.365
Foods 15737 21 CFR 111.210(h)(5)
Foods 15744 21 CFR 111.210(h)(2)
Foods 15752 21 CFR 111.210(c)
Foods 15768 21 CFR 111.420(c)
Foods 15774 21 CFR 111.415(f)(1)
Foods 15791 21 CFR 111.403

Foods 15935 21 CFR 111.105(d)
Foods 15953 21 CFR 111.113(a)(1)
Foods 15964 21 CFR 111.113(c)
Foods 15970 21 CFR 111.120
Foods 15973 21 CFR 111.120(c)
Foods 15989 21 CFR 111.127
Foods 16043 21 CFR 111.503
Foods 16047 21 CFR 111.510
Foods 16074 21 CFR 111.35(b)(4)
Foods 16117 21 CFR 118.4
Foods 16205 21 CFR 118.10(b)(3)
Foods 16494 FDCA 601(c)
Foods 16495 FDCA 601(c)
Foods 18158 21 CFR 117.80(b)(5)

Foods 18164 21 CFR 117.80(c)(9)
Foods 18167 21 CFR 117.95(a)(3)
Foods 18288 21 CFR 1.505(d)
Foods 18334 21 CFR 1.510(b)(1)
Foods 19067 21 CFR 117.155(b)
Foods 19072 21 CFR 117.150(a)(1)
Foods 19081 21 CFR 117.170(d)
Foods 21049 21 CFR 112.32

Foods 21098 21 CFR 112.123(a)
Foods 21109 21 CFR 112.126(b)
Foods 21134 21 CFR 112.140(b)
Foods 21141 21 CFR 112.142(e)(1)
Foods 21177 21 CFR 112.150(b)(1)
Foods 21274 21 CFR 117.206(a)(1)
Foods 21283 21 CFR 117.475(c)
Foods 976 21 CFR 123.9(b)(2)
Foods 1040 21 CFR 113.10
Foods 1066 21 CFR 110.40(b)
Foods 1067 21 CFR 110.40(c)
Foods 1125 21 CFR 110.40(a)
Foods 1128 21 CFR 110.40(a)
Foods 1129 21 CFR 110.40(a)
Foods 1130 21 CFR 110.40(a)
Foods 1329 21 CFR 113.100(a)
Foods 1353 21 CFR 129.35(a)(3)(i)
Foods 1394 21 CFR 129.37(a)
Foods 1401 21 CFR 129.37(a)
Foods 1402 21 CFR 110.10(b)(4)

Foods 1405 21 CFR 110.10(b)(6)
Foods 1426 21 CFR 110.20(b)(5)
Foods 1483 21 CFR 113.87(a)
Foods 1484 21 CFR 113.87(a)
Foods 1487 21 CFR 113.87(b)
Foods 1529 21 CFR 113.89
Foods 1533 21 CFR 113.100(b)
Foods 1578 21 CFR 110.37(f)
Foods 1600 21 CFR 110.37(a)
Foods 1639 21 CFR 113.100(b)
Foods 1689 21 CFR 110.80
Foods 1734 21 CFR 113.40(a)(2)(iii)
Foods 1812 21 CFR 129.80(c)
Foods 1963 21 CFR 129.80(h)
Foods 2273 21 CFR 129.80(g)(1)
Foods 2283 21 CFR 129.80(f)
Foods 2301 21 CFR 129.80(f)
Foods 2385 21 CFR 110.80(a)(1)
Foods 2848 21 CFR 113.40(g)(1)(i)(B)(3)

Foods 2888 21 CFR 113.40(j)
Foods 3074 21 CFR 114.80(a)(2)
Foods 3079 21 CFR 114.80(b)
Foods 3647 21 CFR 110.10(c)
Foods 3870 21 CFR 113.60(a)(2)
Foods 3885 21 CFR 113.87(c)
Foods 4514 21 CFR 108.35(c)(1)
Foods 4518 21 CFR 108.35(c)(2)(ii)
Foods 4523 21 CFR 108.35(f)
Foods 4529 21 CFR 108.35(c)(2)(ii)
Foods 6011 21 CFR 123.8(a)(3)(ii)
Foods 6012 21 CFR 123.8(a)(3)(iii)
Foods 6014 21 CFR 123.6(c)(2)
Foods 9946 21 CFR 120.11(b)
Foods 9953 21 CFR 120.11(a)(1)(iv)(A)
Foods 12720 21 CFR 1.225

Foods 15381 21 CFR 111.8
Foods 15391 21 CFR 111.10(b)(3)
Foods 15433 21 CFR 111.15(d)(1)
Foods 15443 21 CFR 111.15(b)(2)
Foods 15465 21 CFR 111.20(d)(2)
Foods 15466 21 CFR 111.20(c)
Foods 15467 21 CFR 111.20(c)(1)
Foods 15482 21 CFR 111.23(c)
Foods 15493 21 CFR 111.25(b)
Foods 15534 21 CFR 111.255(c)
Foods 15542 21 CFR 111.260(b)
Foods 15550 21 CFR 111.260(j)
Foods 15573 21 CFR 111.153
Foods 15599 21 CFR 111.160(d)(1)
Foods 15610 21 CFR 111.165(d)(1)
Foods 15613 21 CFR 111.165(e)
Foods 15623 21 CFR 111.180(b)(2)
Foods 15665 21 CFR 111.303
Foods 15671 21 CFR 111.315

Foods 15673 21 CFR 111.315(a)
Foods 15681 21 CFR 111.315(d)
Foods 15715 21 CFR 111.375(b)
Foods 15720 21 CFR 111.370
Foods 15736 21 CFR 111.353
Foods 15742 21 CFR 111.210(h)(3)
Foods 15743 21 CFR 111.210(h)(3)
Foods 15746 21 CFR 111.210(h)(1)
Foods 15749 21 CFR 111.210(e)
Foods 15751 21 CFR 111.210(d)
Foods 15754 21 CFR 111.210(a)
Foods 15760 21 CFR 111.205(b)(1)
Foods 15775 21 CFR 111.415(e)
Foods 15778 21 CFR 111.415(b)
Foods 15779 21 CFR 111.415(a)
Foods 15803 21 CFR 111.560(c)
Foods 15821 21 CFR 111.60(a)
Foods 15834 21 CFR 111.70(c)(2)

Foods 15841 21 CFR 111.70(f)
Foods 15860 21 CFR 111.75(a)(2)
Foods 15880 21 CFR 111.75(f)(2)
Foods 15938 21 CFR 111.105(f)
Foods 15939 21 CFR 111.105(g)
Foods 15952 21 CFR 111.113
Foods 15954 21 CFR 111.113(a)(2)
Foods 15963 21 CFR 111.113(b)(2)
Foods 15975 21 CFR 111.120(e)
Foods 15995 21 CFR 111.127(d)
Foods 16001 21 CFR 111.130(a)
Foods 16017 21 CFR 111.140(b)(3)
Foods 16065 21 CFR 111.35(b)(1)
Foods 16122 21 CFR 118.4(a)(2)(i)
Foods 16131 21 CFR 118.4(b)
Foods 16133 21 CFR 118.4(b)(2)
Foods 16144 21 CFR 118.4(d)
Foods 16150 21 CFR 118.4(e)
Foods 16156 21 CFR 118.5(b)
Foods 16172 21 CFR 118.7(a)
Foods 16206 21 CFR 118.10(b)(3)

Foods 16307 21 CFR 113.40(a)(8)
Foods 16501 21 CFR 129.35(a)(4)(i)
Foods 18156 21 CFR 117.80(b)(1)
Foods 18157 21 CFR 117.80(b)(2)
Foods 18256 21 CFR 1.502(b)(1)
Foods 18282 21 CFR 1.505(b)
Foods 18291 21 CFR 1.506(a)(1)
Foods 18296 21 CFR 1.506(d)(1)(i)
Foods 18299 21 CFR 1.506(d)(1)(ii)
Foods 18300 21 CFR 1.506(d)(2)
Foods 18303 21 CFR 1.506(e)(1)
Foods 18331 21 CFR 1.510(a)(2)
Foods 18563 21 CFR 1.512(b)(2)
Foods 19029 21 CFR 117.310
Foods 19083 21 CFR 117.180(d)
Foods 21026 21 CFR 112.11
Foods 21037 21 CFR 112.30(b)

Foods 21091 21 CFR 112.113
Foods 21107 21 CFR 112.126(a)(1)
Foods 21137 21 CFR 112.142(a)
Foods 21145 21 CFR 112.143(b)
Foods 21167 21 CFR 112.147(b)
Foods 21275 21 CFR 117.206(a)(5)
Foods 938 21 CFR 123.9(c)
Foods 939 21 CFR 123.9(f)
Foods 972 21 CFR 123.8(a)(1)
Foods 977 21 CFR 123.9(b)(3)
Foods 985 21 CFR 110.10(b)(1)
Foods 1005 21 CFR 110.10(b)(7)
Foods 1006 21 CFR 110.10(b)(8)
Foods 1060 21 CFR 123.11(a)
Foods 1126 21 CFR 110.40(a)
Foods 1184 21 CFR 110.35(e)
Foods 1255 21 CFR 129.20(a)
Foods 1286 21 CFR 129.35(a)(1)
Foods 1292 21 CFR 110.20(b)(1)
Foods 1303 21 CFR 113.81(f)
Foods 1359 21 CFR 129.35(a)(3)(i)

Foods 1415 21 CFR 129.37(c)
Foods 1417 21 CFR 129.37(c)
Foods 1424 21 CFR 110.20(b)(4)
Foods 1425 21 CFR 110.20(b)(4)
Foods 1472 21 CFR 113.83
Foods 1485 21 CFR 113.87(a)
Foods 1499 21 CFR 113.89
Foods 1500 21 CFR 113.89
Foods 1534 21 CFR 113.100(b)
Foods 1556 21 CFR 110.35(b)(2)
Foods 1565 21 CFR 110.35(d)(3)
Foods 1570 21 CFR 110.35(d)(5)
Foods 1577 21 CFR 110.37(f)
Foods 1581 21 CFR 110.37(e)
Foods 1598 21 CFR 110.37(b)(4)
Foods 1602 21 CFR 110.37(a)
Foods 1640 21 CFR 113.100(b)
Foods 1641 21 CFR 113.100(b)
Foods 1648 21 CFR 113.40(a)(1)
Foods 1651 21 CFR 113.40(a)(1)
Foods 1660 21 CFR 113.40(a)(1)(v)
Foods 1696 21 CFR 110.80(b)(3)

Foods 1697 21 CFR 110.80(b)(4)
Foods 1701 21 CFR 110.80(b)(7)
Foods 1702 21 CFR 110.80(b)(8)
Foods 1708 21 CFR 110.80(b)(12)
Foods 1711 21 CFR 110.80(b)(15)
Foods 1716 21 CFR 113.40(a)(11)
Foods 1732 21 CFR 113.40(a)(2)(i)
Foods 1806 21 CFR 129.80(b)(1)
Foods 1865 21 CFR 113.40(a)(12)
Foods 1944 21 CFR 129.80(d)
Foods 2101 21 CFR 113.40(a)(13)
Foods 2111 21 CFR 113.40(b)(4)
Foods 2142 21 CFR 113.40(b)(1)
Foods 2150 21 CFR 113.40(b)(2)
Foods 2154 21 CFR 113.40(b)(2)(iii)
Foods 2167 21 CFR 113.40(b)(10)
Foods 2169 21 CFR 113.40(b)(10)
Foods 2272 21 CFR 129.80(e)
Foods 2298 21 CFR 129.80(f)
Foods 2342 21 CFR 113.40(c)(6)
Foods 2367 21 CFR 129.80(a)

Foods 2384 21 CFR 110.80(a)(7)
Foods 2386 21 CFR 110.80(a)(1)
Foods 2389 21 CFR 110.80(a)(5)
Foods 2537 21 CFR 113.40(f)(2)(iii)
Foods 2838 21 CFR 113.40(g)(1)(i)(A)
Foods 2846 21 CFR 113.40(g)(1)(i)(B)(1)
Foods 2858 21 CFR 113.40(g)(1)(i)(F)
Foods 2862 21 CFR 113.40(g)(1)(i)(G)
Foods 2885 21 CFR 113.40(i)
Foods 2889 21 CFR 113.40(g)(2)(i)(A)
Foods 2898 21 CFR 113.40(g)(2)(ii)(C)
Foods 2899 21 CFR 113.40(g)(2)(ii)(C)
Foods 3068 21 CFR 114.80(a)(1)
Foods 3077 21 CFR 114.80(b)
Foods 3090 21 CFR 114.100(d)
Foods 3091 21 CFR 114.100(e)
Foods 3857 21 CFR 113.60(a)
Foods 3865 21 CFR 113.60(a)(1)
Foods 3874 21 CFR 113.60(b)
Foods 3881 21 CFR 113.60(d)
Foods 3886 21 CFR 113.87(e)

Foods 4068 21 CFR 113.40(a)(4)
Foods 4069 21 CFR 113.40(b)(14)
Foods 4295 21 CFR 110.40(a)
Foods 4476 21 CFR 108.25(c)(3)(ii)
Foods 4512 21 CFR 108.25(g)
Foods 4520 21 CFR 108.35(c)(3)(ii)
Foods 4528 21 CFR 108.35(c)(2)(ii)
Foods 6009 21 CFR 123.8(a)(3)(iii)
Foods 9917 21 CFR 120.10(c)
Foods 9926 21 CFR 120.14(a)
Foods 9933 21 CFR 120.6(b)
Foods 9938 21 CFR 120.7(d)
Foods 9963 21 CFR 120.24(c)
Foods 12704 21 CFR 129.80(a)
Foods 12717 21 CFR 129.80(h)
Foods 12725 21 CFR 129.80(b)(1)
Foods 12751 21 CFR 120.8(b)(7)
Foods 15304 21 CFR 120.12(g)
Foods 15380 21 CFR 111.8
Foods 15382 21 CFR 111.8

Foods 15398 21 CFR 111.10(b)(8)
Foods 15406 21 CFR 111.13(b)
Foods 15407 21 CFR 111.14(a)
Foods 15411 21 CFR 111.14(b)(2)
Foods 15427 21 CFR 111.15(h)
Foods 15432 21 CFR 111.15(e)(2)
Foods 15437 21 CFR 111.15(a)(1)
Foods 15444 21 CFR 111.15(c)(1)
Foods 15447 21 CFR 111.15(c)(3)
Foods 15448 21 CFR 111.15(f)(1)
Foods 15458 21 CFR 111.20(d)(1)(i)
Foods 15463 21 CFR 111.20(d)(1)(v)
Foods 15469 21 CFR 111.20(c)(3)
Foods 15473 21 CFR 111.20(c)(7)
Foods 15500 21 CFR 111.27(a)(2)
Foods 15504 21 CFR 111.27(a)(3)(iv)
Foods 15505 21 CFR 111.27(a)(3)(v)
Foods 15507 21 CFR 111.27(a)(5)(i)

Foods 15508 21 CFR 111.27(a)(5)(ii)
Foods 15510 21 CFR 111.27(a)(7)
Foods 15521 21 CFR 111.27(d)(6)
Foods 15528 21 CFR 111.30(d)
Foods 15529 21 CFR 111.30(e)
Foods 15544 21 CFR 111.260(d)
Foods 15549 21 CFR 111.260(i)
Foods 15556 21 CFR 111.260(j)(2)(iv)
Foods 15558 21 CFR 111.260(k)(1)
Foods 15559 21 CFR 111.260(k)(1)
Foods 15561 21 CFR 111.260(k)(3)
Foods 15566 21 CFR 111.260(l)(3)
Foods 15568 21 CFR 111.260(m)
Foods 15586 21 CFR 111.155(e)
Foods 15596 21 CFR 111.160(c)(3)
Foods 15597 21 CFR 111.160(c)(3)
Foods 15605 21 CFR 111.165(c)
Foods 15624 21 CFR 111.180(b)(3)
Foods 15625 21 CFR 111.180(b)(3)

Foods 15627 21 CFR 111.180(b)(3)
Foods 15630 21 CFR 111.180(b)(3)(i)
Foods 15633 21 CFR 111.180(b)(3)(ii)(C)
Foods 15648 21 CFR 111.465(a)(2)
Foods 15649 21 CFR 111.465(a)(1)
Foods 15651 21 CFR 111.465(a)(2)
Foods 15652 21 CFR 111.465(b)
Foods 15653 21 CFR 111.470
Foods 15689 21 CFR 111.315(b)(3)
Foods 15704 21 CFR 111.325(a)
Foods 15705 21 CFR 111.325(a)
Foods 15709 21 CFR 111.325(b)(2)
Foods 15710 21 CFR 111.325(b)(2)(i)
Foods 15712 21 CFR 111.325(b)(2)(ii)
Foods 15734 21 CFR 111.360
Foods 15745 21 CFR 111.210(h)(1)
Foods 15753 21 CFR 111.210(b)
Foods 15767 21 CFR 111.425
Foods 15783 21 CFR 111.410(d)

Foods 15784 21 CFR 111.410(c)
Foods 15802 21 CFR 111.560(c)
Foods 15805 21 CFR 111.570(a)
Foods 15810 21 CFR 111.570(b)(2)
Foods 15811 21 CFR 111.570(b)(2)(i)
Foods 15812 21 CFR 111.570(b)(2)(ii)(A)
Foods 15813 21 CFR 111.570(b)(2)(ii)(B)
Foods 15820 21 CFR 111.55
Foods 15823 21 CFR 111.60(b)
Foods 15833 21 CFR 111.70(c)(1)
Foods 15846 21 CFR 111.73
Foods 15848 21 CFR 111.73
Foods 15849 21 CFR 111.73
Foods 15854 21 CFR 111.73
Foods 15867 21 CFR 111.75(b)(1)
Foods 15883 21 CFR 111.75(i)
Foods 15886 21 CFR 111.77(b)
Foods 15890 21 CFR 111.80(a)

Foods 15893 21 CFR 111.80(c)
Foods 15894 21 CFR 111.80(d)
Foods 15901 21 CFR 111.83(b)(3)
Foods 15902 21 CFR 111.83(b)(4)
Foods 15908 21 CFR 111.90(b)(1)
Foods 15931 21 CFR 111.105
Foods 15934 21 CFR 111.105(c)
Foods 15940 21 CFR 111.105(h)
Foods 15941 21 CFR 111.105(i)
Foods 15943 21 CFR 111.105(i)
Foods 15945 21 CFR 111.105(i)
Foods 15948 21 CFR 111.110
Foods 15950 21 CFR 111.110(b)
Foods 15955 21 CFR 111.113(a)(3)
Foods 15960 21 CFR 111.113(b)(1)
Foods 15967 21 CFR 111.117(b)
Foods 15981 21 CFR 111.123(a)(5)
Foods 15984 21 CFR 111.123(a)(8)
Foods 15990 21 CFR 111.127(a)

Foods 15998 21 CFR 111.127(g)
Foods 15999 21 CFR 111.127(h)
Foods 16007 21 CFR 111.135
Foods 16010 21 CFR 111.140(a)
Foods 16020 21 CFR 111.140 (b)(3)(ii)
Foods 16023 21 CFR 111.140(b)(3)(v)
Foods 16037 21 CFR 111.605
Foods 16040 21 CFR 111.610(a)
Foods 16044 21 CFR 111.503
Foods 16045 21 CFR 111.503
Foods 16049 21 CFR 111.520
Foods 16066 21 CFR 111.35(b)(1)(i)
Foods 16067 21 CFR 111.35(b)(1)(ii)
Foods 16069 21 CFR 111.35(b)(1)(iii)
Foods 16072 21 CFR 111.35(b)(3)
Foods 16083 21 CFR 111.35(b)(6)
Foods 16105 FDCA 417(g)
Foods 16189 21 CFR 118.10(c)
Foods 16190 21 CFR 118.10(a)(1)

Foods 16194 21 CFR 118.10(a)(3)(iii)
Foods 16196 21 CFR 118.10(a)(3)(v)
Foods 16201 21 CFR 118.10(d)
Foods 16203 21 CFR 118.10(b)(1)
Foods 16288 21 CFR 113.100(b)
Foods 16306 21 CFR 113.100(h)
Foods 16308 21 CFR 113.40(a)(1)(iv)
Foods 16313 21 CFR 113.40(a)(1)
Foods 16317 21 CFR 113.40(a)(1)(iii)
Foods 16354 21 CFR 113.40(c)(5)
Foods 16459 21 CFR 113.40(g)(1)(i)(B)
Foods 16472 21 CFR 113.40(g)(1)(ii)(E)
Foods 16488 21 CFR 113.40(i)
Foods 16489 21 CFR 113.40(j)
Foods 16490 21 CFR 113.40(j)
Foods 16499 21 CFR 129.35(a)(3)(i)
Foods 16504 21 CFR 129.35(b)
Foods 16508 21 CFR 129.80(f)
Foods 16510 FDCA 402(a)(4)
Foods 16511 21 CFR 129.35(a)(3)(i)
Foods 17004 FDCA 402(a)

Foods 18170 21 CFR 117.110(b)
Foods 18271 21 CFR 1.504(d)
Foods 18286 21 CFR 1.505(c)(2)
Foods 18305 21 CFR 1.506(e)(1)(i)(B)
Foods 18306 21 CFR 1.506(e)(1)(i)(D)
Foods 18310 21 CFR 1.506(e)(1)(iv)(B)
Foods 18311 21 CFR 1.506(e)(1)(iv)(B)
Foods 18333 21 CFR 1.510(b)(1)
Foods 18400 21 CFR 117.315

Foods 18401 21 CFR 117.320
Foods 18541 21 CFR 1.507(a)(2)(i)
Foods 18561 21 CFR 1.512(b)(1)(ii)
Foods 18573 21 CFR 1.512(b)(3)(ii)
Foods 18586 21 CFR 1.512(b)(5)(iii)(B)
Foods 18588 21 CFR 1.512(c)(1)(i)
Foods 18701 21 CFR 106.30(e)(2)(ii)
Foods 18778 21 CFR 106.55(c)

Foods 18860 21 CFR 106.100(d)
Foods 18875 21 CFR 106.100(f)(2)
Foods 19053 21 CFR 117.150(a)(2)
Foods 19069 21 CFR 117.145(a)
Foods 19071 21 CFR 117.145(c)(1)
Foods 19073 21 CFR 117.150(a)(2)
Foods 19075 21 CFR 117.165(a)(4)
Foods 21029 21 CFR 112.21(a)
Foods 21059 21 CFR 112.43(a)(2)
Foods 21061 21 CFR 112.44(a)
Foods 21102 21 CFR 112.123(d)(2)
Foods 21103 21 CFR 112.123(e)
Foods 21104 21 CFR 112.124
Foods 21108 21 CFR 112.126(a)(2)
Foods 21129 21 CFR 112.132(a)
Foods 21131 21 CFR 112.133
Foods 21140 21 CFR 112.142(d)
Foods 21149 21 CFR 112.144(b)(2)
Foods 21166 21 CFR 112.147(a)

Foods 21168 21 CFR 112.147(b)
Foods 21178 21 CFR 112.150(b)(4)
Foods 21186 21 CFR 112.161(a)
Foods 21282 21 CFR 117.435(b)
Foods 21381 21 CFR 1.908(a)(6)
Foods 21384 21 CFR 1.908(a)(3)
Foods 21385 21 CFR 1.908(a)(6)
Foods 21388 21 CFR 1.908(b)
Foods 21391 21 CFR 1.908(a)(3)
Foods 21399 21 CFR 117.80(b)(3)

Short Description
Develop FSVP
Personnel
Pest Control
Sanitation monitoring
Sanitary Operations - Plant Maintenance
HACCP plan implementation
Plant Construction and Design
Manufacturing, Processing, Packing, Holding - Controls
Equipment and Utensils - Design and Maintenance
Hazard Analysis - Identification of Hazard
Sanitary Facilities and Control
Sanitary Operations - Plant Sanitation
Food safety hazards
Critical limits
Critical control points
Sanitation of food contact surfaces - frequency
Training of employees and records
Food Safety Plan
Corrective action plan
Specifications - identity, purity, strength, composition

No HACCP plan
Monitoring - adequacy
Sanitation Records
Storage and Transportation
Importer verification
Written procedures - quality control operations
Signed and dated
Plant Operations - precautions
Sanitation Controls Verif Procedures: Establish

Implement
Grounds
Preventive Controls - Identify
Sanitation Controls Monitoring Proced: Establish

Implement
Process Control - Foreign Objects
Batch record - complete
Sanitation of non-food contact surfaces - frequency
Process filing
Verification - record review - frequency
Written procedures - holding

Cleaning and sanitizing substances- safe and adequate
Supply-Chain Program Establish and Implement

Develop FSVP
Sanitation Controls Procedures
Component - qualify supplier
HACCP training or qualification
Process Controls Monitoring Procedures: Establish

Implement
Specifications - component identity
Written procedures - product complaint
Specifications-component purity, strength, composition
Component - verify identity, dietary ingredient
Toxic Chemicals - identified, held, stored
Verification procedures - adequacy
Master manufacturing record - each batch
Instruments and Controls
Calibration - adequacy
Allergen Controls Monitoring Proced: Establish

Implement
Specifications met - verify; finished batch
Process Controls Verif Procedures: Establish Implement
Scheduled process establishment
Appropriate quality control operations
Scheduled process
Corrective action per predetermined plan

Sanitation monitoring
Maintenance of processing and production records
Written procedures - returned dietary supplement
Hazard analysis
Code - required elements
Sanitation monitoring documentation
Raw Materials - Allergen Identification
Supplier approval - document

Process Controls Corrective Action Proced: Estab
Implement
Allergen Controls Procedures
Quality control - quality, dietary supplement
Master manufacturing record - unique formulation
Reserve sample - collect, hold
Procedures - establish, approve supplier
Registration
Specifications - contamination limits
Hazard analysis written
Hazard Analysis - Written

Verification procedures - none/frequency
Records - content
Lack of effective pest exclusion
Master manufacturing record theoretical and expected

yield
Specifications - labels, packaging
Evaluation - performance, risk
Sanitation Controls - Monitoring Frequency
HACCP plan location
Coding - required elements
HACCP plan not implemented
Management responsibilities - qualified individuals
Personnel
Batch record - every batch
Production, process controls - implement
Specifications - contamination limits
Supplier verification - establish written procedures
Preventive Controls - Written
Supply-Chain Appropriate Verification Activities
Floors, walls and ceilings

Approved school
Verification - CCP, CA record review
Processes, specifications, written procedures
Process Controls Validation Not Performed
Records values/observations
Use of testing procedures
Process adherence
HACCP plan - critical limits not listed or not adequate
Specifications - manufacturing process
Quality control - supplier qualification
Process Control Measures
Sanitation Controls - Monitoring Records

Screening
Buildings/sanitary
Recall procedures
Approved school
Records entries - timing
Corrective action per regulation

Ongoing verification - complaints, calibration records
Process controls - HACCP plan - 5 log reduction
Written procedures - holding; distributing
Records - packaging, labeling operations
Written SE plan not implemented/followed
Temperature Devices
Verification - recordkeeping
Quality control procedures
Process adherence
HACCP plan - corrective action plan not included
Records - returned dietary supplement: written

procedures
Testing when laying hens 40 to 45 weeks
Definition very small importer
Process Controls Corrective Action Procedures -

Content
Preventive controls records - general requirements
Written environmental monitoring plan
Written sampling plan for spent irrigation water or

sprouts
Initial temperature of container contents
Raw materials, packaging, finished product

Verification activities - minimum
HACCP plan - critical control points not listed
Equipment - automated - calibrate, inspect
Master manufacturing record - controls, procedures
Specifications met - test, examinations; compliance
Specifications not met - reject, quality control
Document-equipment date of use, maintain, clean,

sanitize
Process Controls Monitoring Frequency
Determination of compliance
Container testing
Monitoring record review adequacy
Sanitation SSOP - none or not implemented
All hazards not considered
Personnel - education, training, experience
Procedures - equipment - cleaning, sanitizing
Written procedures - labeling operations
Specifications - finished packaging, labeling
Written procedure quality control operations material

review
Written SE plan lacks required elements
Stray animals
Process Controls Procedures - Adequate
Allergen Controls Corrective Action Proced: Estab

Implement
Recall Plan - Written
Verification - reviewers qualifications
Corrective action documentation
HACCP plan - location and type of juice
HACCP plan - food hazards not listed
Personnel - quality control personnel - qualified
Personnel - records - training
Instruments - calibration
Batch record - date, time; maintenance
Hold - temperature, humidity, light
Conditions, controls -protect; microorganisms,

contamination
Written procedures - product complaint; review,

investigate
Documentation - qualify supplier
QC operations - master manufacturing record,

modifications
Reportable food report - submission
Removal of pest harborages
Hazard analysis biological, chemical, physical
Customer Disclosure
Process Controls Monitoring Records
Process Controls Record Review
Sanitation Controls Corrective Action Proced: Estab

Implemnt
Sanitation Controls Corrective Action Records
Sanitation Controls Record Review
Environmental testing requirements
Supply-Chain Supplier Approval

Supply-Chain Written Procedures for Receiving Raw
Materials
Raw materials and Rework Controls - Filth and
Contamination
Reassessment of HACCP plan
Hazard analysis - written - elements
HACCP plan - monitoring procedures not adequate
HACCP plan - verify procedures / frequency - none

listed
Records - not signed and dated by qualified individual
Physical plant - clean and sanitary
Written procedures - cleaning
Records - cleaning, pest control
Procedures - calibrating instruments
Batch record - component; identity, weight
Hold - mix-up, contamination, deterioration
Record - product complaint; findings

Specifications met identity,purity, strength, comp,; basis
Reserve sample -container-closure system
Ensure quality; package, labeled, master record
Quality control operations - finished batch,

specifications
Quality control - batch, product specifications
Records - ret'nd dietary supplement: material review,

dispos
Documentation - instruments, controls; calibrations
Monitoring for rodents
Monitoring for flies
Refrigeration requirements documentation
Raw Materials - Thawing
Very small importer assurances, supplier
Corrective Action for Unanticipated Food Safety

Problems
Process Controls Corrective Action Records
Allergen Controls - Monitoring Records
Training for supervisors
Testing spent irrigation water
Verification - corrective action
Not washed/sanitized when appropriate
Still retorts
Safety lighting and glass
Cleaning and sanitizing operations
Review not signed/dated
Chemical, physical, radiological tests - bottled water
Records of process establishment
Sanitation corrections
Lack of records
No hazard analysis
No HACCP plan
HACCP plan - not validated
Records required - not maintained
HACCP plan - valid procedures / frequency - none listed
No AE report made (dietary supplement)
Written procedures - pest control
Equipment - design - suitable
Batch record - yield
Examination, testing; appropriate

Packaging description, representative label
Master manufacturing record - specifications; quality
Product complaint - quality control review
Appropriate tests, examinations; certificate of analysis
Component - certificate of analysis
Documentation - supplier qualification
Quality control operations - batch production records
Satisfactory fly control methods
Biosecurity measures documentation
Date and time of activity
Document review entity's hazard analysis
Verification activity assurance
Training Records - general requirements
Food Safety Plan - Preparation
Process Controls Verification Records

Sanitation Controls Corrective Action Procedures -
Content
Other Controls Verification Procedures: Establish
Implement
Maintain, follow FSVP
Modified Requirement Temp Control - Monitor,

Corrective Action, Verification
Process controls
Supervisors
Harborage areas
Contamination with microorganisms, chemicals, filth,

etc.
Scheduled processes not established
As source of contamination
Records - equipment inspection
Thermal processing
pH testing
Process deviation
Processing and production - required information
Process filing
Records system
Records - general - include name, date, time
Records - signed/dated
Records - actual values
HACCP plan - monitoring procedures - none listed
Hand-washing facilities
Sanitation supervisors - assigned

Pest control measures
Equipment - maintain, clean, sanitize
Equipment - maintain - general
Batch record - initials; verifying weight
Written procedures - components
Components - quarantine
Metal, foreign material
Labels - issuance, use
Product complaint - quality control investigate
Quality control, review, approve; investigate, follow-up
In-process identity, purity, strength, composition
Specifications - product received for packaging, labeling
Specifications met - identity, purity, strength,

composition
Re-confirm certificate of analysis
Specifications met - verify; production, process control
Tests, examinations - scientifically valid
Quality control operations - tests, examinations; results
Records - quality control operations; responsibilities
QC ops; written procedures; material review,

disposition
Rodent and pest control documentation

Human Food By-Products
Allergen Controls - Monitoring Frequency
Allergen Controls Verif Procedures: Establish Implement
Other Controls Procedures
Reanalysis Frequency
Food contact surface sanitary inspection and
maintenance
Hazard Controlled by Entity other than Supplier
Qualified Facility Attestation - Hazards and Monitoring
Precautions against contamination--micro, foreign

substances
Q.C. instrument accuracy, maintenance
Fill
Process records - forms missing information
Sample frequency - product water
Suitability - equipment, utensils
Buildings/good repair
Shown to be effective
Storage/transportation of finished goods

(contamination)
Manufacturing conditions
Unauthorized adjustment
Bacteriological test - bottled water

Suitable locations
Hand cleaning and sanitizing preparations
Critical factors - no record
Process deviation identification
Corrective action - predetermined plan inadequate
SSOP records
Process controls - not exempt, single facility
Records - cleaning, sanitizing solutions
Corrective action - predetermined plan
Calibration, testing - no records
Personnel - hygienic practices
Hair restraints
Personnel - quality control operations
Personnel - records - written procedures
Physical plant - bulbs, fixtures, skylights
Physical plant - screening against pests
Equipment - bonded seams
Batch record - follow master
Batch record - 1 year, 2 years
Batch record - results; monitoring

Batch record - packaging, labeling
Batch record - label
Batch record - quality control review; production
Written procedures - labels
Components - contamination, deterioration, mix-ups
Components - identify lot received
Components - identify lot produced
Packaging - identify
Written procedures - product received
Records - product distribution
Written procedures - laboratory operations
Examination, testing; scientifically valid
Written procedures, laboratory operations
Manufacturing operations - prevent contamination
Corrective action plans
Master manufacturing record - sampling, tests,

examinations
Master manufacturing record - components; weight,
measure
Repackaged, relabeled - quality control: approve,
rejects
Batch-lot,control number packaged, labeled dietary
supplemen
Written procedures -packaging operations

Quality control - basis; tests, examinations
QC production, process control; material review,

disposition
Document - material review, disposition
Quality control operations - components, packaging,

labels
QC operations - material review, disposition decision
Quality control operations - packaging, labeling

Written procedures - returned dietary supplement;
destroyed
Returned dietary supplement - material review,
disposition
Records - equipment; calibrations, inspections, checks
No written SE prevention plan
Signatures or initials on operational records
Insanitary conditions; contaminated with filth
Insanitary conditions; injurious to health
Identification Of Rework
Adulterated Food Disposition
Human Food By-Product: Identifying as Animal food
Evaluation, reevaluation - another entity
Record - translate to English
Sanitation Controls - Verification Records

Other Controls Corrective Action Proced: Establish
Implement
Reanalysis Revise Food Safety Plan After Reanalysis
Hygienic practices
Equip & tools - cleanability
Buildings - prevent contamination
Records - equipment cleaning and sanitizing
Treat seed with a scientifically valid method
Record - treatment
Modified Requirement Temp Control - Establish

Implement
Supply-Chain Records
Process adequacy records
Operators
Seams on food contact surfaces
Non food-contact equipment in processing area
Materials and workmanship
Installation and maintenance of equipment (S)
Food-contact - corrosion resistant
Food-contact - withstand food & cleaning cmpds.
Process records - not done; not timely
Sample - total coliforms
Product water-contact surfaces - clean
Product water-contact surfaces - inspection
Unsecured jewelry
Failure to wear
Adequate lighting
Operating processes not posted
Vent not posted
Visual indicators not used
Process deviation log/file
Recording device records - dated; retort number
Odor, attractant for pests, harborage
General inadequacy
Entry not timely
Reasonable precautions
Adjusted to agree with TID
Sample, test - cleaning, sanitizing solutions
Records - availability
Representative samples - bottled water
Performance monitoring - filler, capper, sealer
Bacteriological swab, rinse count - containers, closures

(S)
Inspection, segregation, handling of raw materials

Critical factors - frequency measured, recorded
Using pH meter
Code - packing period
Training of handlers and supervisors
Glass containers; cold water vacuum check
Initial temperature: cans in water filled retorts
Registration
Process change - increase
Recall procedures
Process change reporting to CFSAN
Corrective action record review adequacy
Calibration record review adequacy
Monitoring - none
Validation - reviewer's qualifications
CCP record review adequacy
Not registered
Written procedures - hygienic practices
Hand washing
Animals and pests in facility
Physical plant - repair
Air blowing equipment
Physical plant - prevent mix-ups, contamination
Physical plant - receiving, holding, identifying
Records - water
Procedures - calibrating automated, mechanical equip
Batch record - each step
Batch record - date, time; maintenance
Batch record - manufacture
Written procedures - product received; packaging,

labeling
Labels - identify
Product received - identify
Product received - mix-ups

Records - receiving; components, packaging, labels,
products
Written procedures - tests, examinations; specifications
met
Laboratory control processes - requirements
Criteria for establishing specifications
Standard reference materials; criteria for selecting
Records - manufacturing operations; written

procedures
Rejected dietary supplements - identify, hold, control
Manufacturing operations - written procedures
Specific actions; packaged, labeled
Master manufacturing record - specific actions; quality
Instructions; specifications; quality
Master manufacturing record - intentional overage
Master manufacturing record - Supplemental Facts
Master manufacturing record - dietary ingredients
Master manufacturing record-specifications; packaged,

label
Dietary supplement containers - mix-ups
Dietary supplement - protect, contamination
Clean, sanitize - filling, packaging equipment
Product complaint -investigate, findings, follow-up
Production, in- process control system - design, quality
Specifications identity, purity strength, composition

Specifications - product received for packaging, labeling
Component - confirm identity; specifications met
Label - visual examination, review supplier's

documentation
Quality control - representative samples
Quality control - reserve samples
Quality control operations - material review, disposition
QC master manufacturing record; material review,

disposition
Quality control - reject; specification not met
Quality control operations - quarantine
QC operations - packaged, labeled; specifications
QC returned dietary supplement; material review,

disposition
Records - material review, disposition
Written procedures - equipment, utensils; make, keep
Pullet environment testing
Transfer or introduction of SE
Cross contamination from equipment
Before new laying hens added
Eggs to be processed as table eggs
Environmental testing after induced molting period
Plan appropriate to layout
Signature and date on SE plans

Still steam retorts: Bleeder not wide open during
process
Public water system test results, certificates
Raw Material Control - Cleaning - Water Quality
Raw Materials Control - Treatment for Microorganisms
LACF compliance
Supplier approval - evaluation
Procedures - establish unapproved supplier
Verification activity frequency
Verification activity - appropriate
Onsite audit
Verification activity before import, periodically
Record - sign, date
Assurance, small supplier
Food Safety Plan - Signing
PCQI Training Records
General requirement to prevent foreseeable food safety

hazards
Training records
Handling harvested produce
Building size, construction, and design
Prevent hazards on seed
Sanitary food contact surfaces
Aseptic samples - sprouts and spent irrigation water
Modified Requirement Temp Control - Records
Official review
Computerized records
Modification HACCP plan
Records stored at another location
Suitable outer garments
Storage of personal items
Personal food/drink/tobacco
SSOP(S)
Precluding contaminants
Storage of cleaned portable equipment (S)
Bottling room separation, plant operations
Approved source - product, operations water
Sufficient space
Critical Factors
Records - source water approval, sampling, analysis

Single service containers, caps, seals - sanitary closure
Single-service container, cap, seal-exam, sanitize,

handle
Drip and condensate
Spacing of equipment
Critical factors not stated
Scheduled processes not available
No corrective action taken
Evaluation by process authority
Entry not made
Storage requirements
Non-food-contact surfaces (S)
Safe and adequate for use
Contamination of food, contact surfaces, water

supplies, etc
Running water at suitable temperature
Drainage
Suitable temp. and pressure
Record form not signed
Review not timely
No TID
TID accuracy test frequency
TID not reference instrument
Holding foods - refrigerate/freeze/heat

Preventive control measures
Equipment, containers, utensils
Metal / extraneous materials
Batters, breading, gravies, sauces, etc.
Proper pH controls
Water valves, leakage
Range, chart graduations
Mechanical washers - records
Timing before vent, before temperature reached
Sanitizing operations inadequate
Measured, recorded
Steam controller
No accurate TID
Present each retort, accurate
Unauthorized adjustment
No indicator
Operator check, record, frequency
Records - product, volume, date, code, distribution
Inspection - containers, closures
Heat distribution data not on file
Effective treatment - product water

Receipt/storage - liquid and dry raw materials
Storage
Identify rework
No accurate TID
Recorder range, chart graduations
Located upstream from holding tube
Holding tube - heated, slope
Thermal processing crit factors-methods, controls

adequate
Instrumented - container closure sterilization
Operating conditions observed, recorded - frequency
Operating conditions - observed, recorded
pH control
Visible code
Product distribution
Retention
Record: visual closure examination, qualified person
Teardown examinations - record of corrective action
Cooling water - not chlorinated, sanitized
Postprocess handling: equipment design, closure

integrity
Thermal processing - clock time agreement with time

of day
Maintenance of steam activated controller
Heat distribution data, other retort installation
Food contact - non-toxic materials
Process information availability
Record retention
Process information availability
Process change recording
Verification - record review - calibration
Corrective action documentation
Importer - written procedures
GMP correction - timely
Hazard analysis - evaluation of effect on safety (S)
Process controls - exempt process, single facility
Product water samples - Analysis frequency
Certificates - retain at plant
Mechanical washers - inspection
HACCP plan - recordkeeping system
Records - computerized
Written procedures - sick or infected personnel
Written procedures - personnel qualifications

Food, gum, beverages, tobacco
Supervisor - education, training
Personnel - records - retention
Personnel - records - training date, type, persons
Bathrooms - adequate, accessible
Water supply - may be component - suitability
Grounds - equipment, litter, weeds
Cleaning compounds
Cleaning compounds and toxic materials - holding
Plumbing - sufficient water
Floors, walls, ceilings
Physical plant - aisles, working spaces
Physical plant - separate areas for products
Physical plant - separate areas - holding
Equipment - design - no contamination
Equipment - withstand environment
Equipment - protect from contamination
Refrigerator, freezer - temperature recording device

Refrigerator, freezer - alarm
Compressed air, gases
Cleaning compounds - adequate, safe
Equipment - automated - controls, process changes
Equipment - controls, intended use
Batch record - component; unique identifier
Batch record - specifications
Batch record - initials; verifying component
Batch record - identifier; packaging
Batch record - identifier; labels
Batch record - tests, examinations; results
Batch record - approved, released, rejected; batch
Batch record - performance
Components - contamination, deterioration, mix-ups
Packaging - quality control; approve, release
Labels - quality control; approve, release
Product received - quarantine
Documentation - components
Documentation - components
Documentation - product received; packaging, labeling
Document - required operation
Documentation - required operation; results
Hold - reserve sample; closure system
Hold - reserve samples; ordinary storage
Hold - reserve sample; closure system- packaged,

labeled
Retain reserve samples - 1 year, 2 years

Distribute dietary supplement; contamination,
deterioration
Sampling plans; finished batches
Laboratory operations: 1 year, 2 years
Laboratory operations: originals, copies, electronic
Laboratory methodology followed
Document; laboratory methodology followed
Records - document; results
Manufacturing operations - sanitation
Instructions; specifications; packaged, labeled
Master manufacturing record - list components
Quarantine - rejected packaged, labeled dietary

supplement
Manufacturing history
Packaging, labels - master manufacturing record
Product complaint - review, investigation
Records - product complaints: 1 year, 2 years
Record - product complaint; good manufacturing

practice
Record - person document; time of performance
Record - product complaint; name, description
Record - product complaint; batch, lot, control number
Production, process controls - packaged, labeled
Production, in-process control system review, approved
Specifications - in-process contamination limits
Specifications met - packaged, labeled, master record
Specifications met - component purity, strength,

composition
Specifications met - contamination limits
Specifications met - contamination limits
Specifications met, in-process - quality finished batch
Corrective action plan
Specifications not met - identity; component, reject
Components packaging, labels used

Specifications - representative samples; finished batch
Specifications - representative samples; unique lot
Reserve sample - retained
Reserve sample - twice the quantity
Reprocessed, dietary supplement - no material review
Quality control - packaged, labeled
Basis; in-process, component, specifications
Quality control - production, process control
QC required operations production and process control
QC required operations components packaging labels
QC - required operations packaging/labeling operations
Quality control operations - laboratory operations
Quality control operations - tests, examinations
Quality control - adulteration; material review,

disposition
Quality control - dietary supplement; adulteration
Quality control operations - calibration records
Quality control operations - reprocessing
Quality control - finished batch, distribution
Quality control operations - packaging, visual

examinations
Quality control operations - labeling; relabeling
QC operations - packaging, labeling; approving,

rejecting
Quality control operations - product complaints
Records - QC operations: originals, copies, electronic
Material review, disposition, follow-up; investigation
Material review, disposition, follow-up; explanation
Records - keep: 1 year, 2 years
Records - available; FDA
Written procedures - returned dietary supplement;

salvaged
Written procedures returned dietary supplement;
reprocessing
Returned dietary supplement - salvaged
Written procedures - instruments, controls; calibrating
Procedures - equipment; calibrating, inspecting,

checking
Procedures contact surfaces; maintaining, cleaning,

sanitize
Instruments, controls; calibrate date, reference std,

method
Documentation - equipment functions; intended use
Records maintenance
Records retention time
Written SE prevention plan

Depopulation cleaning and disinfection procedures
Sampling procedures documentation
24 hour retrieval of offsite records
Name and location
Review of processing and production records
Electronic records
Still steam retorts: TID not accurate to 1 ?F
RD accuracy test frequency
Still Retorts: TID defective, could not be adjusted
Continuous agitating retorts: bleeders wide open
Aseptic processing: recorder, permanent record
Aseptic processing:recorder, holding tube

temperatures, freq
Thermal processing:Instrument dependability - critical

facts
Other systems: Methods, controls - scheduled process
Other systems: Commercial sterility
Coliforms - follow up testing
Air - contact surface - oil, dust, rust, moisture
Container sample results
On farm processing of shell eggs
Sample frequency - operations water
Food Field Exam

Mixing of Adulterated Food
Review entity's hazard analysis
Reevaluate - 3 years
Audit - food safety regulation, plan
Audit - document
Verification activity - document
Verification activity document requirements
Record - available
Record Retention
Record Availability
Disclosure - customer subject cGMP
Written assurance, small supplier
Qualified facility assurance
Record - 2 years, procedures
Small foreign supplier compliance
Cold storage, in-process and final formula - 45 degrees

F
Production aggregate sample - final stage, distribution

Record - premix supplier, purity each nutrient
Certification of accuracy, history recertification
Allergen Controls Corrective Action Procedures -

Content
Other Controls Monitoring Procedures - Establish
Implement
Other Controls - Monitoring Records
Other Controls Corrective Action Procedures - Content
Other Controls Record Review
Personnel training
Ag water treatment delivery
Ag. water - E.coli standard
Non-food-contact surface maintenance and cleaning
Produce contact with equipment
Instrument accuracy, maintenance, and quantity
Buildings - drainage
Waste / trash disposal and storage
Plumbing size, design, installation, and maintenance
Requirement to inspect seed
Testing when no irrigation water generated
Representative samples
Release before negative test results
Analytical testing record
Record requirements
Supply-Chain Onsite Audit Coverage
Receiver Operations - Action After Material Failure of

Temperature Control
Shipper Operations - Transportation Operations
Shipper Operations - Action After Material Failure of

Temperature Control
Shipper Operations - Written Procedures
Carrier Operations - Transportation Operations
Raw materials Controls - Natural toxins

Long Description
You did not develop an FSVP. Specifically, ***
You did not take a reasonable measure and precaution related to personnel practices. Specifically, ***
You did not [exclude pests from your food plant] [use pesticides under precautions and restrictions] to
protect against contamination of food. Specifically, ***
You are not monitoring the sanitation conditions and practices with sufficient frequency to assure
conformance with Current Good Manufacturing Practices including [safety of water that comes into
contact with food or food contact surfaces, including water used to manufacture ice] [condition and
cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects]
[maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging
material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic
chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, ***
You did not [maintain your plant in a clean and sanitary condition] [keep your plant in repair].
Specifically, ***
You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP
plan. Specifically, ***
Your plant was not [constructed] [designed] to facilitate maintenance and sanitary operations.
Specifically, ***
You did not conduct operations under conditions and controls necessary to minimize the potential for
[growth of microorganisms] [allergen cross-contact] [contamination of food] [deterioration of food].
Specifically, ***
Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained
to protect against [allergen cross-contact] [contamination]. Specifically, ***
Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a
preventive control. Specifically, ***
Your plant did not have adequate sanitary facilities and accommodations. Specifically, ***
You did not clean and sanitize your utensils or equipment in a manner that protects against [allergen
cross-contact] [contamination]. Specifically, ***
Your HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, ***
Your HACCP plan [does not list a critical limit that ensures control of one or more hazards] [lists a critical
limit that does not ensure control of one or more hazards]. Specifically,
Your HACCP plan does not list one or more critical control points that are necessary for each of the
identified food safety hazards. Specifically, ***
You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against
[allergen cross-contact] [contamination of food]. Specifically, ***
You did not [train employees in the principles of food hygiene and food safety] [have records
documenting training of qualified individuals]. Specifically, ***
You did not have a written food safety plan. Specifically, ***
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to
ensure [affected product is not entered into commerce] [the cause of the deviation was corrected].
Specifically***
You did not establish product specifications for the [identity] [purity] [strength] [composition] of the
finished dietary supplement. Specifically, ***
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably
likely to occur. Specifically, ***
Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the
critical limit. Specifically***
You are not maintaining sanitation control records that document [monitoring] [corrections of sanitation
deficiencies] for [safety of water that comes into contact with food or food contact surfaces, including
water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-
contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet
facilities] [protection of food, food packaging material, and food contact surfaces from adulteration]
[proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion
of pests]. Specifically, ***
You did not store or transport food, including ingredients, under conditions that protect against [allergen
cross-contact] [contamination] [deterioration] [adulteration]. Specifically, ***
You do not have or have not implemented [written verification procedures] [product specifications] [an
affirmative step] for ensuring that [fish] [fishery products] you import are processed in compliance with
the Seafood HACCP regulation. Specifically, ***
You did not [establish] [follow] written procedures for quality control operations. Specifically, ***
Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least
annually]. Specifically, ***
You did not [conduct operations in accordance with adequate sanitation principles] [have plant
sanitation under the supervision of a competent individual] [take adequate precautions to ensure that
production procedures did not contribute to allergen cross-contact and to contamination]. Specifically,
***
You did not [establish] [implement] adequate written sanitation controls verification procedures for
[product testing] [environmental monitoring]. Specifically, ***
You did not keep the grounds around your plant in a condition that would protect against the
contamination of food. Specifically, ***
You did not identify a preventive control for a hazard when one was needed. Specifically, ***
You did not [establish] [implement] adequate written procedures for monitoring sanitation controls.
Specifically, ***
You did not take an adequate measure to protect against inclusion of metal or extraneous material in
food. Specifically, ***
Your batch production record did not include complete information relating to the production and
control of each batch. Specifically, ***
You did not clean your non-food contact surface in a manner and as frequently as necessary to protect
against [allergen cross-contact] [contamination]. Specifically, ***
You did not provide FDA with information on the scheduled process for a new acidified food before
packing the food. Specifically, ***
You did not review [some of] your [critical control point monitoring] [corrective action] [calibration] [in-
process testing] [end-product testing] records [within one week] [within a reasonable time] after the
records were made. Specifically, ***
You did not [establish] [follow written] procedures for holding and distributing operations. Specifically,
***
You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the
conditions of use. Specifically, ***
You did not [establish] [implement] a written supply-chain program. Specifically, ***
You did not develop an FSVP. Specifically, ***
Your sanitation controls procedures did not ensure [cleanliness of food-contact surfaces] [prevention of
allergen cross-contact] [prevention of cross-contamination]. Specifically, ***
You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of
analysis through confirmation of the results of their tests or examinations. Specifically, ***
No one associated with your firm has completed the required HACCP training or is HACCP qualified
through job experience. Specifically, ***
You did not [establish] [implement] adequate written procedures for monitoring process controls.
Specifically, ***
You did not establish an identity specification for each component. Specifically, ***
You did not [establish] [follow] written procedures for the requirements to review and investigate a
product complaint. Specifically, ***
You did not establish component specifications for [purity] [strength] [composition]. Specifically, ***
You did not conduct at least one appropriate test or examination to verify the identity of a dietary
ingredient, prior to its use. Specifically, ***
You did not [identify] [hold] [store] a toxic chemical in a manner that protects against contamination.
Specifically, ***
Your HACCP plan lists verification [procedures] [frequencies] that have not been developed in
accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety
hazards, and is being effectively implemented. Specifically, ***
You did not [prepare] [follow] a written master manufacturing record for each batch size of a dietary
supplement that you manufactured. Specifically, ***
Your instruments and controls were not [accurate] [precise] [adequately maintained] [adequate in
number]. Specifically, ***
Your process monitoring equipment is not calibrated to ensure that it reads accurately. Specifically, ***
You did not [establish] [implement] adequate written procedures for monitoring allergen controls.
Specifically, ***
You did not verify that your finished batch of dietary supplement meets product specifications for
[identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead
to adulteration of the dietary supplement]. Specifically, ***
You did not [establish] [implement] adequate written process controls verification procedures.
Specifically, ***
A scheduled process was not established by a qualified person who has expert knowledge acquired
through appropriate training and experience in acidification and processing of acidified foods.
Specifically, ***
You did not have appropriate quality control operations to ensure that [food is suitable for human
consumption] [food packaging materials are safe and suitable]. Specifically, ***
Acidified food is not manufactured in accordance with the scheduled process. Specifically, ***
You did not take corrective action that ensured [affected product was not entered into commerce] [the
cause of the deviation was corrected]. Specifically,***
You are not monitoring the sanitation conditions and practices with sufficient frequency to assure
conformance with current good manufacturing practice including [safety of water that comes into
contact with food or food contact surfaces, including water used to manufacture ice] [condition and
cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects]
[maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging
material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic
chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, ***
You did not maintain [processing] [production] records showing adherence to the scheduled process.
Specifically, ***
You did not [establish] [follow] written procedures for when a returned dietary supplement is received.
Specifically, ***
You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food
safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.
Specifically, ***
Each container is not marked with an identifying code specifying the [establishment where the product
was packed] [product contained therein] [year] [date] [packing period]. Specifically, ***
Your sanitation control records do not accurately document the conditions or practices observed at your
firm. Specifically***_x000D_
_x000D_
You did not [identify] [hold] raw materials and other ingredients that are food allergens, and rework that
contains food allergens, in a manner that protects against allergen cross-contact. Specifically, ***
You did not document your approval of your foreign supplier. Specifically, ***
You did not [establish] [implement] adequate written corrective action procedures for process controls.
Specifically, ***
Your allergen controls procedures did not include appropriate controls for [protection of food from
allergen cross-contact] [labeling]. Specifically, ***
You did not implement quality control operations to ensure the quality of the dietary supplement.
Specifically, ***
You did not [prepare] [follow] a written master manufacturing record for each unique formulation of a
dietary supplement that you manufactured. Specifically, ***
You did not collect and hold reserve samples of packaged and labeled dietary supplements that you
distributed. Specifically, ***
You did not establish written procedures to ensure that you import foods only from foreign suppliers you
have approved based on an evaluation of the foreign supplier's performance and the risk posed by the
You did not register and file Form FDA 2541 (food canning establishment registration) with FDA within 10
days after first engaging in the manufacture, processing and packaging of acidified foods. Specifically, ***
You did not establish limits for contamination that may adulterate or may lead to adulteration of the
finished dietary supplement. Specifically, ***
You did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable
hazards [to determine whether there are any hazards requiring a control]. Specifically, ***
Your hazard analysis was not written. Specifically, ***

Your HACCP plan does not list verification [procedures] [frequencies] that have been developed to
ensure that the HACCP plan is adequate to control food safety hazards, and is being effectively
implemented. Specifically, ***
Your records do not include the [name and location of the processor or importer] [date and time of the
activity the record reflects] [signature or initials of the person performing the operation] [identity of the
product and the production code, if any]. Specifically, ***
Effective measures are not being taken to [exclude pests from the processing areas] [protect against the
contamination of food on the premises by pests]. Specifically, ***
Your master manufacturing record did not include a statement of [the theoretical yield for each point,
step, or stage of the manufacturing process to ensure quality control] [the expected yield of the finished
dietary supplement] [the maximum and minimum percentages of theoretical yield beyond which a
deviation investigation of a batch is necessary and material review is conducted and disposition decision
is made]. Specifically, ***
You did not establish [label] [packaging] specifications. Specifically, ***_x000D_
You did not document the evaluation you conducted to determine [a foreign supplier's performance]
[the risk posed by a food]. Specifically, ***
Your sanitation controls monitoring frequency was not adequate. Specifically, ***
Your HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery
product processed]. Specifically, ***
The identification code for hermetically sealed containers did not identify in code the [establishment
where packed] [product in the container] [year packed] [day packed] [period during which packed].
Specifically, ***
You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures
listed in your HACCP plan. Specifically, ***
You did not ensure that all individuals are qualified to perform their duties. Specifically, ***
Operators of processing and packaging systems are not under the operating supervision of a person who
has attended and satisfactorily completed a school approved by the Commissioner. Specifically, ***
You did not prepare a batch production record every time you manufactured a batch of dietary
supplement. Specifically, ***
You did not implement a system of production and process controls that covers all stages of
manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the
dietary supplement. Specifically, ***
You did not establish product specifications for limits on contamination that may adulterate, or that may
lead to adulteration of, the finished dietary supplement. Specifically, ***
You did not establish [adequate] written procedures for ensuring that appropriate foreign supplier
verification activities are conducted with respect to a food you import. Specifically, ***
You did not have written preventive controls. Specifically, ***

You did not [determine] [conduct] [document] appropriate supplier verification activities. Specifically,
***
The plant is not constructed in such a manner as to allow [floors] [walls] [ceilings] to be [adequately
cleaned and kept clean] [kept in good repair]. Specifically, ***
Personnel involved in [acidification] [pH control] [heat treatment] [critical factors of the operation] were
not under the operating supervision of a person who attended and satisfactorily completed a school
approved by the FDA Commissioner. Specifically, ***
You did not review [all of] your [critical control point monitoring] [corrective action] records within one
week (7 days) of the day the records are made. Specifically, ***
Your quality control personnel did not approve or reject [processes] [specifications] [written procedures]
[controls] [tests] [examinations] [deviations or modifications] that may affect the identity, purity,
strength, or composition of a dietary supplement. Specifically, ***
You did not validate that your process controls are adequate to control the hazard. Specifically, ***
Your monitoring records do not contain the actual values and observations obtained during monitoring.
Specifically, ***
You did not use testing procedures to identify [sanitation failures] [possible allergen cross-contact] [food
contamination]. Specifically, ***
You did not process a food in conformity with at least the scheduled process filed with FDA. Specifically,
***
Your HACCP plan [does not list one or more of the critical limits that must be met at each critical control
point] [lists a critical limit that does not prevent, eliminate, or reduce to an acceptable level the
occurrence of an identified food hazard]. Specifically, ***
You did not establish a specification for a point, step, or stage in the manufacturing process where
control is necessary to ensure [the quality of the dietary supplement] [that the dietary supplement is
packaged and labeled as specified in the master manufacturing record]. Specifically, ***
Your quality control personnel did not review and approve the documentation setting forth the basis for
qualification of suppliers. Specifically, ***
You did not take an adequate measure to destroy or prevent the growth of undesirable microorganisms
in your food. Specifically, ***
You did not have sanitation controls monitoring records. Specifically, ***
Failure to provide adequate screening or other protection against pests. Specifically, ***
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, ***
You did not prepare and maintain files on current procedures for [recalling products that may be
injurious to health] [identifying, collecting, warehousing, and controlling products] [determining the
effectiveness of recalls] [notifying FDA of recalls] [implementing recall programs]. Specifically, ***
Operators of [retorts] [thermal processing systems] [aseptic processing and packaging systems]
[container closure inspections] were not under the operating supervision of a person who attended and
satisfactorily completed a school approved by the FDA Commissioner. Specifically, ***
Processing or other information was not [always] entered on your records at the time it was observed.
Specifically, ***
You did not take corrective action that ensured [the affected product was segregated] [a review of the
affected product was done to determine its acceptability] [affected product was not entered into
commerce] [the cause of the deviation was corrected] [the HACCP plan was reassessed in a timely
manner to determine if modifications were needed to reduce the risk of reoccurrence of the deviation
and modified as necessary]. Specifically, ***
Your verification procedures do not include, at a minimum, ongoing verification activities including
[review of consumer complaints] [calibration of process monitoring instruments] [review of monitoring,
corrective action, and calibration records]. Specifically, ***
Your HACCP plan does not include control measures that will consistently produce a 5 log reduction in
the most resistant microorganism of public health significance that is likely to occur in the juice, for a
period at least as long as the shelf life of the product. Specifically, ***
You did not make and keep written procedures for holding and distributing operations. Specifically, ***
You did not make and keep records of the written procedures for [packaging] [labeling] operations.
Specifically, ***
Your written SE prevention plan is not [fully] implemented and followed. Specifically,***
Your cold storage unit used to store and hold food did not have a temperature device [installed] [installed
to show temperature accurately]. Specifically, ***
You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or
in-process testing]. Specifically, ***
Appropriate quality control procedures are not employed to ensure that finished foods do not present a
health hazard. Specifically, "***
You did not process each low-acid canned food in conformity with at least the filed scheduled processes
and modifications. Specifically, ***
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 120.10(a) to
ensure [affected product is not entered into commerce] [the cause of the deviation was corrected].
Specifically,***
You did not make and keep records of written procedures for fulfilling requirements for returned dietary
supplements. Specifically, ***
Environmental testing for SE, using approved methods, was not done in a poultry house when any group
of laying hens constituting the flock was 40 to 45 weeks of age. Specifically,***
You chose to comply with the requirements for a very small importer, but you did not document that you
meet the definition of a very small importer [before initially] [annually each year after] importing food as
a very small importer. Specifically, ***
Your corrective action procedures for process controls were not adequate. Specifically, ***
Your preventive controls records did not meet general records requirements. Specifically, ***
You did not [establish] [implement] a written environmental monitoring plan designed to identify L.
monocytogenes if it is present in the growing, harvesting, packing or holding environment. Specifically,
***
You did not [establish] [implement] a written sampling plan for each production batch of sprouts.
Specifically, ***
The initial temperature of the contents of the containers to be processed was not [determined]
[recorded] with sufficient frequency to ensure the temperature of the product was no lower than the
minimum initial temperature specified in the scheduled process. Specifically, ***
Records are not maintained of the examination of [raw materials] [packaging materials] [finished
products] [supplier's guarantees or certificates] to verify compliance with FDA regulations and guidelines
or action levels. Specifically, ***
Your verification activities do not include, at a minimum, [review of consumer complaints to determine
whether they relate to the performance of the HACCP plan] [calibration of process monitoring
instruments] [end-product or in-product testing] [review of critical control point monitoring, corrective
action, and calibration records] to ensure that your HACCP system is being properly implemented.
Specifically, ***
Your HACCP plan does not list the critical control points for each of the identified food hazards.
Specifically, ***
You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to
ensure proper performance. Specifically, ***
Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch
met specifications. Specifically, ***
You did not conduct appropriate tests or examinations to determine compliance with the specifications
established for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate
or that may lead to adulteration of the dietary supplement]. Specifically, ***
Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] for
which a specification was not met. Specifically, ***
You did not make and keep documentation of [the date of the use] [maintenance] [cleaning] [sanitizing]
of the equipment. Specifically, ***
Your process controls monitoring frequency was not adequate. Specifically, ***
You have not provided evidence that the [fish] [fishery products] you import have been processed under
conditions that comply with the Seafood HACCP regulation. Specifically, ***
You did not [test] [examine] containers often enough to ensure that the containers suitably protected the
food from leakage and contamination. Specifically, ***
Your review of critical control point monitoring records does not [ensure that the records are complete]
[verify that they document values that are within critical limits]. Specifically, ***
You do not [always] have or have not implemented a sanitation standard operating procedure that
addresses sanitation conditions and practices before, during and after processing. Specifically, ***
In evaluating what food hazards are reasonably likely to occur, [you] [the person who performed the
evaluation for you] did not consider [microbiological contamination] [parasites] [chemical
contamination] [unlawful pesticide residues] [decomposition] [natural toxins] [use of unapproved color
or food additives] [presence of undeclared ingredients that may be allergens] [physical hazards].
Specifically, ***
Personnel engaged in [manufacturing] [packaging] [labeling] [holding] dietary supplements do not have
the education, training, or experience to perform the person's assigned functions. Specifically, ***
You did not [establish] [follow] written procedures for maintaining, cleaning, and sanitizing, equipment,
utensils, and any other contact surfaces that are used to manufacture, package, label, or hold
components or dietary supplements. Specifically, ***
You did not [establish] [follow] written procedures for labeling operations. Specifically, ***
You did not establish specifications [for the packaging and labeling of the finished dietary supplement]
[to ensure that you used the specified packaging] [to ensure that you applied the specified label].
Specifically, ***
You did not [establish] [follow] written procedures for quality control operations for conducting a
material review and making a disposition decision. Specifically, ***
Your written SE prevention plan lacks appropriate SE prevention measures. Specifically,***
Stray animals are not prevented from entering poultry houses. Specifically,***
Your process controls procedures did not include appropriate [parameters] [maximum/minimum values].
Specifically, ***
You did not [establish] [implement] adequate written corrective action procedures for allergen controls.
Specifically, ***
You did not have a written recall plan. Specifically, ***
The [reassessment of your HACCP plan] [monitoring, corrective action, or verification record review] was
not done by an individual who had successfully completed training in the application of HACCP principles
to fish and fishery product processing, or was otherwise qualified through job experience to perform
these functions. Specifically, ***
You do not have records that document corrective actions that were taken. Specifically, ***
Your HACCP plan is not specific to [each location where juice is processed] [each type of juice
processed]. Specifically, ***
Your HACCP plan does not list all food hazards that are reasonably likely to occur. Specifically, ***
The personnel you identified to perform quality control operations [are not qualified to do so] [do not
have the education, training or experience to perform the assigned functions]. Specifically, ***
You did not make and keep documentation of training. Specifically, ***
You did not calibrate instruments or controls used in manufacturing or testing a component or dietary
supplement [before the first use] [at the frequency specified in writing by the manufacturer or at routine
intervals or as necessary] to ensure the accuracy and precision of the instruments or controls.
Specifically, ***
Your batch production records did not include the date and time of the maintenance, cleaning, and
sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to
records, such as individual equipment logs, where this information is retained. Specifically, ***
You did not hold [components] [dietary supplements] under appropriate conditions of temperature,
humidity, or light so that their identity, purity, strength, and composition are not affected. Specifically,
***
You did not perform manufacturing operations under conditions and controls that protect against [the
potential for growth of microorganisms] [the potential for contamination]. Specifically, ***
You did not make and keep written procedures to fulfill the requirements that apply to the review and
investigation of a product complaint. Specifically, ***
You did not maintain documentation of how you qualified the supplier of a component. Specifically, ***
Your quality control operations did not include reviewing and approving [master manufacturing records]
[modifications to the master manufacturing records]. Specifically, ***
You did not submit a reportable food report to FDA within 24 hours after you determined that a food was
a reportable food. Specifically, ***
Potential harborages for pests in and outside your poultry house have not been eliminated by [removing
debris within a poultry house] [removing debris and vegetation outside the poultry house].
Specifically,***
Your hazard analysis did not include a known or reasonably foreseeable [biological] [chemical] [physical]
hazard that requires a control. Specifically, ***
You did not disclose to your customer that your food is not processed to control an identified hazard.
Specifically, ***
You did not have process controls monitoring records. Specifically, ***
Your process controls records [were not reviewed by a preventive controls qualified individual or such
review was not overseen by a preventive controls qualified individual] [were not reviewed within
specified timeframes]. Specifically, ***
You did not [establish] [implement] adequate written corrective action procedures for sanitation
controls. Specifically, ***
You did not have sanitation controls corrective action records. Specifically, ***
Your sanitation controls records [were not reviewed by a preventive controls qualified individual or such
review was not overseen by a preventive controls qualified individual] [were not reviewed within
specified timeframes]. Specifically, ***
You did not test for Listeria spp. or Listeria monocytogenes in your [growing] [harvesting] [packing]
[holding] environment. Specifically, ***
You did not [approve] [document your approval of] a supplier. Specifically, ***
You did not [establish] [implement] [document the use of] written procedures for receiving raw materials
and other ingredients. Specifically, ***
You did not ensure that raw materials and other ingredients were not contaminated with [pests]
[undesirable microorganisms] [extraneous materials]. Specifically, ***
Your verification procedures do not include, at a minimum, reassessment of the HACCP plan [at least
annually] [whenever modifications to the process are made]. Specifically, ***
Your written hazard analysis does not consist of [an identification of food hazards] [an evaluation of each
food hazard identified to determine if it must be addressed in the HACCP plan] [an identification of the
control measures that can be applied] [a review of your current process to determine whether
modifications are necessary] [an identification of critical control points]. Specifically, ***
Your HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not
ensure compliance with the critical limits. Specifically, ***
Your HACCP plan does not list the verification [procedures] [frequencies] that have been developed to
ensure that the HACCP plan is being implemented. Specifically, ***
Your review of [critical control point monitoring records] [corrective action records] [calibration records]
[periodic end-product or in-process testing records] are not [performed] [signed] [dated] by an individual
who is trained in the application of HACCP principles to juice processing or otherwise qualified through
job experience. Specifically, ***_x000D_
You did not maintain your physical plant in a clean and sanitary condition. Specifically, ***
You did not [establish] [follow] written procedures for cleaning the physical plant. Specifically, ***
You did not make and keep records of the written procedures for [cleaning the physical plant] [pest
control]. Specifically, ***
You did not [establish] [follow] written procedures for calibrating instruments and controls that you use
in manufacturing or testing a component or dietary supplement. Specifically, ***
Your batch production records did not include the [identity] [weight or measure] of each component
used. Specifically, ***
You held [components] [dietary supplements] [packaging] [labels] under conditions that lead to mix-up,
contamination, or deterioration. Specifically, ***
The written record of a product complaint did not include the [findings of the investigation] [follow-up
action taken]. Specifically, ***
You did not provide adequate documentation of your basis for determining that compliance with the
specification[s] you selected for identity, purity, strength, and composition will ensure that the finished
batch of dietary supplement meets the specification[s]. Specifically, ***
Your reserve sample of a dietary supplement was not held using the same container-closure system in
which the packaged and labeled dietary supplement was distributed. Specifically, ***
Your quality control personnel did not ensure that your [manufacturing] [packaging] [labeling] [holding]
operations ensure the quality of the dietary supplement. Specifically, ***
Your quality control operations did not include determining whether each finished batch conforms to
established product specifications. Specifically, ***
Your quality control personnel approved and released for distribution a batch of dietary supplement that
did not meet established product specifications. Specifically, ***
You did not make and keep records of a material review and disposition decision on a returned dietary
You did not make and keep documentation of calibrations for instruments or controls that you use in
manufacturing or testing a component or dietary supplement. Specifically, ***
The presence of rodents is not monitored by appropriate monitoring methods. Specifically,***
The presence of flies is not monitored by appropriate monitoring methods. Specifically,***
You do not maintain records documenting compliance with refrigeration requirements. Specifically***
You did not thaw your raw materials or other ingredients in a manner that prevented them from
becoming adulterated. Specifically, ***
As a very small importer, you did not obtain written assurance, [before importing a food] [every 2 years
after initially importing a food], that your foreign supplier produced the food in compliance with process
and procedures that provide the required level of public health protection. Specifically, ***
You did not take an appropriate corrective action in response to an unanticipated food safety problem.
Specifically, ***
You did not have process controls corrective action records. Specifically, ***
You did not have allergen controls monitoring records. Specifically, ***
You did not employ at least one supervisor or responsible party that has successfully completed
appropriate food safety training. Specifically, ***
You did not test spent irrigation water from each production batch of sprouts for [E. coli O157:H7]
[Salmonella][pathogens reasonably necessary to minimize risk of serious adverse health consequences].
Specifically, ***
You did not take immediate corrective action to ensure that [no affected product entered into
commerce] [the cause of the deviation was corrected] [the HACCP plan was reassessed] when your
verification procedure revealed the need to take a corrective action. Specifically, ***
Employees did not [wash] [sanitize] hands thoroughly in an adequate hand-washing facility [before
starting work] [after each absence from the work station] [at any time their hands may have become
soiled or contaminated]. Specifically, ***
For a still retort, records were not maintained for [the time that steam was turned on] [the time that the
retort reached processing temperature] [the time that steam was shut off] [the venting time] [the
venting temperature]. Specifically, ***
Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed
Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that
protects against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically,
***
A [processing] [production] record was not [signed or initialed] [dated] by the reviewer. Specifically, ***
You did not take and analyze samples of bottled drinking water for [chemical] [physical] [radiological]
testing at least annually [for each type of bottled drinking water produced during a day's production
run]. Specifically, ***
Complete records [covering all aspects of the establishment of the scheduled process] [for incubation
tests associated with establishing the scheduled process] were not [prepared] [permanently retained] by
the person or organization making the determination. Specifically, ***
You did not correct sanitation deficiencies in a timely manner. Specifically,***

You do not have records to document the performance and results of the affirmative steps taken to
demonstrate that [fish] [fishery products] imported into the United States were processed in accordance
with the seafood HACCP regulation. Specifically, ***
You did not develop, or have developed for you, a written hazard analysis to determine whether there
are food hazards that are reasonably likely to occur for [each type of] juice you produce. Specifically,
*** _x000D_
. Specifically, ***
You do not have a written HACCP plan that outlines controls for one or more food safety hazards that are
reasonably likely to occur. Specifically, ***
You did not validate that your HACCP plan is adequate to control food hazards [at least once within 12
months after implementation] [at least annually] [when a change in the process occurred that could have
affected the hazard analysis or altered the HACCP plan in any way]. Specifically, ***
You do not maintain [complete] records documenting [the implementation of your sanitation standard
operating procedure] [your written HACCP plan] [your written hazard analysis] [monitoring of critical
control points and their critical limits] [corrective actions taken in response to a deviation] [the
verification of your HACCP system] [the validation of your HACCP plan] [the validation of your hazard
analysis]. Specifically, ***
Your HACCP plan does not list the validation [procedures] [frequencies] that have been developed to
ensure that the HACCP plan is adequate to control food hazards that are reasonably likely to occur.
Specifically, ***
No report was made of a serious adverse event associated with a dietary supplement marketed in the
United States. Specifically, ***
You did not [establish] [follow] written procedures for pest control. Specifically, ***
You did not use equipment or utensils of appropriate design, construction, and workmanship to enable
them to be [suitable for its intended use] [adequately cleaned] [properly maintained]. Specifically, ***
Your batch production records did not include [a statement of the actual yield] [a statement of the
percentage of theoretical yield] at appropriate phases of processing. Specifically, ***
You did not verify that the laboratory examination and testing methodologies are appropriate for their
intended use. Specifically, ***
Your master manufacturing record did not include [a description of the packaging] [a representative
label, or a cross-reference to the physical location of the actual or representative label]. Specifically,
Your master manufacturing record did not identify specifications for the points, steps, or stages in the
manufacturing process where control is necessary to ensure the quality of the dietary supplement.
Specifically, ***
A qualified person did not review a product complaint to determine whether the product complaint
involved a possible failure of a dietary supplement to meet specifications or any other requirements.
Specifically, ***
You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine
whether components met established specifications. Specifically, ***
The certificate of analysis for a component does not include [a description of the test or examination
method(s) used] [limits of the test or examination] [actual results of the tests or examinations].
Specifically, ***
You did not make and keep documentation of your qualification of a supplier. Specifically, ***
Your quality control operations did not include reviewing and approving all batch production-related
records. Specifically, ***
When your monitoring indicated unacceptable fly activity within a poultry house, appropriate methods
were not used to achieve satisfactory fly control. Specifically,***
You did not maintain records documenting compliance with biosecurity measures. Specifically, ***
All your required records do not include the [date] [time] of the activity that the records reflect.
Specifically,***
You did not document [your review and assessment of a hazard analysis conducted by another entity]
[that a hazard analysis conducted by another entity was conducted by a qualified individual].
Specifically, ***
You did not [determine] [document] which verification activity or activities were needed to provide
adequate assurances that a food you obtain from a foreign supplier is produced in compliance with
processes and procedures that provide the required level of public health protection. Specifically, ***
Your training records did not meet general record requirements. Specifically, ***
Your food safety plan was not prepared or its preparation overseen by a preventive controls qualified
individual. Specifically, ***
You did not have process controls verification records. Specifically, ***
Your corrective action procedures for sanitation controls were not adequate. Specifically, ***
You did not [establish] [implement] adequate written verification procedures for an activity that required
a preventive control. Specifically, ***
You did not [maintain] [follow] an FSVP. Specifically, ***
You did not [monitor temperature control with adequate frequency] [take corrective action when there
was a loss of temperature control] [verify implementation of temperature controls]. Specifically,***
Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium
botulinum. Specifically, ***
Supervisors have not satisfactorily completed training in a school approved by the Commissioner for
areas under their responsibility. Specifically, ***
Failure to [properly store equipment] [remove litter and waste] [cut weeds or grass] that may constitute
an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant
buildings or structures. Specifically, ***
Proper precautions to protect [food] [food-contact surfaces] [food-packaging materials] from

contamination with [microorganisms] [chemicals] [filth] [extraneous material] cannot be taken because
of deficiencies in plant [size] [construction] [design]. Specifically, ***
Scheduled processes for low-acid foods have not been established by qualified persons having expert
knowledge of thermal processing. Specifically, ***
Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils].
Specifically, ***
You did not maintain records at the plant pertaining to physical inspection of equipment used for
treatment of product water, including the [type and date of physical inspections of equipment]
[conditions found] [performance and effectiveness of equipment]. Specifically, ***
Acidified foods are not thermally processed to an extent that is sufficient to destroy the vegetative cells
of microorganisms of public health significance and those of nonhealth significance capable of growing
in the food. Specifically, ***
You did not exercise sufficient control so that the finished equilibrium pH of an acidified food was not
higher than 4.6. Specifically, ***
When a process operation deviated from the scheduled process or the equilibrium pH of the finished
product was higher than 4.6, you did not fully reprocess the food by a process established by a
competent processing authority as adequate to ensure a safe product; or thermally process the food as
required for low-acid food; or set aside the food for further evaluation as to any potential public health
significance. Specifically, ***
The [processing] [production] records do not contain sufficient additional information such as [product
code] [date] [container size] [product] to permit a public health hazard evaluation of the processes
applied to each [lot] [batch] [portion] of production. Specifically, ***
You did not provide FDA with information on the scheduled process for a new low-acid canned food prior
to packing the food. Specifically, ***
Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the
critical control points. Specifically, ***
Your required records do not [always] include [the name of the processor] [the name of the importer]
[the location of the processor] [the location of the importer] [the date and time of the activity] [the
signature or initials of the person performing the operation or creating the record] [the identity of the
product] [the production code]. Specifically, ***
Your [written hazard analysis] [written HACCP plan], required by the juice HACCP regulation, [was] [were]
not signed and dated [upon initial acceptance] [upon modification] [upon verification] [upon validation]
[by the most responsible individual onsite at the processing facility or by a higher level official].
Specifically, ***
Your records do not [always] contain the actual values and observations obtained during monitoring.
Specifically, ***
Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical
control point to ensure compliance with the critical limits. Specifically, ***
Your hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a
suitable temperature]. Specifically, ***
You did not assign one or more employees to supervise overall sanitation. Specifically, ***
You did not take effective measures [to exclude pests from the physical plant] [to protect against
contamination of components, dietary supplements, and contact surfaces on the premises by pests].
Specifically, ***
You did not [maintain] [clean] [sanitize] equipment and utensils used to manufacture, package, label, or
hold components or dietary supplements. Specifically, ***
You did not [maintain] [clean] [sanitize] equipment, utensils, and contact surfaces used to manufacture,
package, label, or hold components or dietary supplements. Specifically, ***
Your batch production records did not include the initials of the person responsible for verifying the
weight or measure of each component used in the batch. Specifically, ***
You did not [establish] [follow] written procedures for the requirements for components of dietary
You did not quarantine components before you used them in the manufacture of a dietary supplement.
Specifically, ***
You did not use effective measures to protect against the inclusion of metal or other foreign material in
[components] [dietary supplements]. Specifically, ***
You did not control the [issuance] [use] of labels, Specifically, ***
A qualified person did not investigate a product complaint that involved a possible failure of a dietary
supplement to meet a specification, or other requirement. Specifically, ***
Your quality control personnel did not [review and approve decisions about whether to investigate a
product complaint] [review and approve the findings and follow-up action of an investigation].
Specifically, ***
You did not establish in-process specifications for a point, step, or stage in the master manufacturing
record where control is necessary to help ensure that specifications are met for [identity] [purity]
[strength] [composition]. Specifically, ***
You did not establish specifications to [sufficiently] assure that the product you received for packaging or
labeling as a dietary supplement is adequately identified and is consistent with your purchase order.
Specifically, ***
You did not determine whether you met established product specifications for [identity] [purity]
[strength] [composition of the finished batch of the dietary supplement]. Specifically, ***
You did not periodically re-confirm the supplier's certificate of analysis for a component. Specifically, ***
You did not select one or more established specifications for [identity] [purity] [strength] [composition]
[limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement]
that, if tested or examined on the finished batches of the dietary supplement, would verify that the
production and process control system is producing a dietary supplement that meets all product
specifications. Specifically, ***
You did not ensure that the tests or examinations that you used to determine whether the specifications
are met are appropriate, scientifically valid methods. Specifically, ***
Your quality control operations did not include reviewing and approving the results of required [tests]
[examinations]. Specifically, ***
You did not make and keep written procedures for the responsibilities of the quality control operations.
Specifically, ***
You did not make and keep [written procedures for the responsibilities of the quality control operations
for conducting a material review and making a disposition decision] [written procedures for approving or
rejecting any reprocessing]. Specifically, ***
You did not maintain records documenting compliance with rodent and other pest control measures.
Specifically,***
You did not hold a human food by-product intended for distribution as animal food under conditions that
will protect against contamination. Specifically, ***
Your allergen controls monitoring frequency was not adequate. Specifically, ***
You did not [establish] [implement] adequate written allergen controls verification procedures.
Specifically, ***
Your controls procedures did not ensure that hazards are significantly minimized or prevented.
Specifically, ***
You did not conduct a reanalysis of your food safety plan when required. Specifically, ***
You did not [inspect] [maintain] [clean] [sanitize] food contact surfaces as frequently as necessary to
protect against the contamination of produce. Specifically, ***
You did not [verify another entity's supply-chain-applied control] [obtain another entity's documentation
of appropriate verification activity] [review and assess another entity's applicable documentation]
[document your review and assessment of another entity's documentation]. Specifically, ***
You did not [identify the potential hazard associated with food being produced] [implement preventive
controls to address an identified hazard] [monitor the performance of a preventive control] to ensure
that your controls are effective per your attestation. Specifically, ***
Failure to take necessary precautions to protect against contamination of [food] [food contact surfaces]
[food packaging systems] with [microorganisms] [foreign substances]. Specifically, ***
Instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth
of undesirable microorganisms are not [accurate] [adequately maintained]. Specifically,***
The filling of containers is not controlled to ensure that the filling requirements specified in the
scheduled process are met. Specifically, ***
Processing and production information forms did not include [the product] [the code number] [the date]
[the retort or processing system number] [the size of container] [the approximate number of containers
per coding interval] [the initial temperature] [the actual processing time] [the temperature-indicating
device readings] [temperature-recording device readings] [appropriate processing data]. Specifically, ***
You did not take and analyze samples of product water [as often as necessary] [at least once every year
for chemical contamination] [at least once every four years for radiological contaminants]. Specifically,
***
Plant equipment or utensils were not suitable for their intended use. Specifically, ***
Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from
The [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not
been shown to provide adequate [cleaning] [sanitizing treatment]. Specifically, ***
Failure to [store] [transport] finished food under conditions that would protect against [physical]
[chemical] [microbial] contamination. Specifically, ***
Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize
[the potential for growth of microorganisms] [contamination]. Specifically, ***
A means of preventing unauthorized adjustment to the temperature-recording device was not provided.
Specifically, ***
You did not take and analyze samples of bottled drinking water for bacteriological testing at least once a
week [for each type of bottled drinking water produced during a day's production run]. Specifically, ***
Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed.
Specifically, ***
Lack of effective hand [cleaning] [sanitizing] preparations. Specifically, ***
A record was not was not made of [the closing machine vacuum in vacuum-packed products] [the
maximum fill-in weight] [the drained weight] [a critical factor specified in the scheduled process].
Specifically, ***
When a process was less than the scheduled process or when critical factors were out of control you did
not either fully reprocess the portion of the production involved, keeping full records of the reprocessing
conditions, or set aside the portion of the product involved for further evaluation as to any potential
public health significance. Specifically, ***
You did not take corrective action that ensured [affected product was not entered into commerce] [the
cause of the deviation was corrected]. Specifically, ***
You do not [always] maintain sanitation standard operating procedure records that document [the
monitoring of conditions and practices during processing] [corrections to conditions and practices that
were not met]. Specifically, ***
You do not conduct the 5-log reduction process and perform final packaging of your juice within a single
production facility operating under current good manufacturing practices. Specifically, ***
You did not maintain records of [sampling] [testing] of cleaning and sanitizing solutions. Specifically, ***
Your HACCP plan includes a corrective action plan. There was a deviation from a critical limit and you did
not take corrective action that ensured [product that was injurious to health or otherwise adulterated
did not enter commerce] [the cause of the deviation was corrected]. Specifically, ***
You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or

in-process testing]. Specifically, ***
Your personnel did not use hygienic practices to the extent necessary to protect against contamination of
components, dietary supplements, or contact surfaces. Specifically, ***
Your personnel did not wear [effective] hair restraints [in an effective manner]. Specifically, ***
You have not identified personnel to be responsible for your quality control operations. Specifically, ***
You did not make and keep written procedures for [preventing microbial contamination from sick or
infected personnel] [hygienic practices] [determining personnel qualification requirements]. Specifically,
***
You did not use safety-type [light bulbs] [fixtures] [skylights] [glass] over exposed components or dietary
Your physical plant did not use adequate screening or other protection against pests. Specifically, ***
You used equipment or utensils that do not have seams that are smoothly bonded or maintained to
minimize accumulation of extraneous materials or contaminants. Specifically, ***
Your batch production record did not accurately follow the appropriate master manufacturing record.
Specifically, ***
You did not keep batch production records for the required time period. Specifically, ***_x000D_
Your batch production records did not include the actual results obtained during a monitoring operation.
Specifically, ***
Your batch production records did not include documentation, at the time of performance, of
[packaging] [labeling] operations. Specifically, ***
Your batch production records did not include an actual or representative label, or a cross-reference to
the physical location of the actual or representative label specified in the master manufacturing record.
Specifically, ***
Your batch production records did not include documentation that quality control personnel reviewed
the batch production record. Specifically, ***
You did not [establish] [follow] written procedures for the requirements for labels received. Specifically,
***
You did not hold components under conditions that will [protect against contamination] [protect against
deterioration] [avoid mix-ups]. Specifically, ***
You did not identify each unique lot within each unique shipment of components that you received in a
manner that allows you to trace the lot to [the supplier] [the date received] [the name of the
component] [the status of the component] [the dietary supplement that you manufactured and
distributed]. Specifically, ***
You did not identify each lot of components that you produced in a manner that allows you to trace the
lot to [the supplier] [the date received] [the name of the component] [the status of the component] [the
dietary supplement that you manufactured and distributed]. Specifically, ***
You did not identify each unique lot within each unique shipment of packaging in a manner that allows
you to trace the lot to [the supplier] [the date received] [the name of the packaging] [the status of the
packaging] [the dietary supplement that you distributed]. Specifically, ***
You did not make and keep written procedures for fulfilling the requirements that apply to product
received for packaging or labeling as a dietary supplement and for distribution rather than for return to
the supplier. Specifically,
You did not make and keep records of product distribution. Specifically, ***
You did not [establish] [follow] written procedures for laboratory operations. Specifically, ***
You did not identify and use an appropriate scientifically valid method for each established specification
for which testing or examination is required to determine whether the specification was met.
Specifically, ***
You did not make and keep written procedures for laboratory operations. Specifically, ***
You did not take necessary precautions during the manufacture of a dietary supplement to prevent
contamination of [components] [dietary supplements]. Specifically, ***
The written instructions in your master manufacturing record did not include instructions for corrective
action plans to use when specifications are not met. Specifically, ***
The written instructions in your master manufacturing record did not include [procedures for sampling]
[a cross-reference to procedures for tests or examinations]. Specifically, ***
Your master manufacturing record did not include an accurate weight or measure of each component to
be used. Specifically, ***
Your quality control personnel did not approve or reject each batch of [repackaged] [relabeled] dietary
supplement prior to its release for distribution. Specifically, ***
You did not assign a batch, lot, or control number to each lot of packaged and labeled dietary
supplement from a finished batch of dietary supplement. Specifically, ***
You did not [establish] [follow] written procedures for packaging operations. Specifically, ***
why the results of appropriate tests or examinations for each product specification will ensure that the
finished batch of the dietary supplement meets product specifications. Specifically, ***
Your quality control personnel did not conduct a material review and make a disposition decision for a
specification established for the production and process control system that was not met. Specifically,
***
The person who conducted a material review and made the disposition decision did not document the
material review and the disposition decision [at the time of performance]. Specifically, ***
You do not have quality control operations for [components] [packaging] [labels] before use in the
manufacture of a dietary supplement. Specifically, ***
Your quality control operations did not include conducting a required material review and making a
required disposition decision for [components] [packaging] [labels] prior to [their] use. Specifically, ***
You do not have quality control operations for [packaging] [labeling]. Specifically, ***
You did not [establish] [follow] written procedures for when a returned dietary supplement must be
destroyed, or otherwise suitably disposed. Specifically, ***
You did not identify and quarantine returned dietary supplements until quality control personnel
conducted a material review and made a disposition decision. Specifically, ***
You did not make and keep written records of calibrations, inspections, or checks of automated,
mechanical, or electronic equipment. Specifically, ***
Your firm does not have a written SE prevention plan that is specific to [each farm] [the farm] where you
produce eggs. Specifically,***
All required records do not have the signature or initials of the person performing the operation or
creating the record. Specifically,***
Your cosmetic was prepared, packed, or held under insanitary conditions whereby it may have become
contaminated with filth. Specifically, ***
Your cosmetic was prepared, packed, or held under insanitary conditions whereby it may have been
rendered injurious to health. Specifically, ***
You did not identify materials scheduled for rework. Specifically, ***
You did not properly [dispose of] [recondition] adulterated food. Specifically, ***
You did not accurately identify a human food by-product held for use as animal food. Specifically, ***
You did not document your review and assessment of [an evaluation] [a reevaluation] of a foreign
supplier's performance and the risk posed by a food that was performed by another entity. Specifically,
***
You did not provide an English translation of an FSVP record that you maintained in a language other
than English. Specifically, ***
You did not have sanitation controls verification records. Specifically, ***
You did not [establish] [implement] adequate written corrective action procedures for your controls.
Specifically, ***
You [did not revise your written food safety plan as necessary] [did not document the basis for your
conclusion that no revisions to your food safety plan were necessary]. Specifically, ***
You did not ensure that personnel who may contact produce or food contact surfaces use hygienic
practices to protect against produce contamination. Specifically, ***
You did not use equipment and tools that are of adequate design, construction, and workmanship to
enable them to be adequately cleaned and maintained. Specifically, ***
You did not implement measures to prevent contamination of produce and food contact surfaces
through [floors] [walls] [ceilings] [fixtures] [ducts] [pipes] [drip] [condensate]. Specifically, ***
You did not establish and keep documentation of the date and method of cleaning and sanitizing of
equipment. Specifically, ***
You did not treat your [seeds] [beans] for sprouting with a scientifically valid method to reduce
microorganisms of public health significance. Specifically, ***
You did not establish documentation [of treatment of your seeds or beans] [from your seed supplier that
seeds or beans are treated and appropriately handled and packaged following treatment]. Specifically,
***
You did not [establish] [implement] temperature controls. Specifically, ***
You did not have the required [documentation] [components in the documentation] for the supply-chain
program. Specifically, ***
The records that relate to the general adequacy of your [processes] [equipment] were not maintained for
at least two years after their applicability to the product you produced. Specifically, ***
Operators of [processing systems] [retorts] [aseptic processing systems] [product formulating systems]
are not under the operating supervision of a person that has attended and satisfactorily completed, a
school approved by the Commissioner. Specifically, ***
Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize
accumulation of [food particles] [dirt] [organic matter] and the opportunity for growth of
microorganisms. Specifically, ***
Non food-contact equipment in [manufacturing] [food handling] areas is not constructed so that it can
be kept in a clean condition. Specifically, ***
The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning]
[maintenance]. Specifically, ***
Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent
spaces]. Specifically, ***
Lack of corrosion-resistant food contact surfaces. Specifically, ***
Food contact surfaces are not designed to [withstand the environment of their intended use] [withstand
the action of food] [withstand cleaning compounds and sanitizing agents]. Specifically, ***
Processing and production information was not recorded [at the time it was observed] [by the retort or
processing system operator or other designated person]. Specifically, ***
The [product] [operations] source water that [was] [were] obtained from other than a public water
system [was] [were] not sampled and analyzed for total coliforms at least once each week. Specifically,
***
You did not clean the product water-contact surfaces of all [multiservice containers] [utensils] [pipes]
[equipment] used in the [transportation] [processing] [handling] [storage] of product water.
Specifically,***
You did not inspect all product water-contact surfaces as often as necessary [to maintain the sanitary
condition of such surfaces] [to assure such surfaces are kept free of scale, evidence of oxidation, and
other residue]. Specifically, ***
Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment]
[containers]. Specifically, ***
Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate.
Specifically, ***
Failure to provide adequate lighting in [hand-washing areas] [dressing and locker rooms] [toilet rooms]
[areas where food is examined, stored, or processed] [areas where equipment and utensils are cleaned].
Specifically, ***
Operating processes for each product and container size were not [posted in a conspicuous place near
the processing equipment] [readily available to the retort or processing system operator] [readily
available to FDA investigators]. Specifically, ***
Retort venting procedures for each product and container size were not [posted in a conspicuous place
near the processing equipment] [readily available to the retort or processing system operator] [readily
available to FDA investigators]. Specifically, ***
Each retort [basket] [truck] [car] [crate] that contained retorted food product was not plainly and
conspicuously marked with a heat-sensitive indicator or by other effective means to visually indicate the
retorted units. Specifically, ***
Process deviations were not recorded in a separate file or log that details both the deviations and the
actions taken. Specifically, ***
Temperature-recording device records were not identified by [date] [retort number] [data necessary to
correlate the temperature-recording device with the record of lots processed]. Specifically, ***
The [conveyance] [storage] [disposal] of [rubbish] [offal] does not minimize the [development of odor]
[potential for waste becoming an attractant and harborage or breeding place for pests]. Specifically, ***
Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source].
Specifically, ***
An entry on a [processing record] [production record] was not made at the time the specific retort or
processing system condition or operation occurred. Specifically, ***
All reasonable precautions are not taken to ensure that production procedures do not contribute
contamination from any source. Specifically, ***
A temperature-recording device was not adjusted with sufficient frequency to ensure agreement as
nearly as possible with, but not higher than, the temperature-indicating device during processing.
Specifically, ***
You did not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate
performance. Specifically, ***
You did not make all required documents available for official review at reasonable times. Specifically,
***
Samples collected for [bacteriological] [chemical] [physical] [radiological] analysis were not primary
containers or unit packages from a batch or segment of a continuous production run for each type of
bottled drinking water. Specifically, ***
You did not monitor the performance of the [filler] [capper] [sealer] during processing. Specifically, ***
You did not take a bacteriological swab or rinse count at least every three months from at least four
containers and closures selected just prior to filling and sealing. Specifically, ***
Failure to [inspect] [segregate] [handle] raw materials to ascertain that they are clean and suitable for
processing into food. Specifically, ***
nearly as possible with, but to be in no event higher than, the temperature-indicating device during
processing. Specifically, ***
A critical factor specified in the scheduled process for processing a low-acid food in hermetically sealed
containers was not [measured] [recorded] at intervals of sufficient frequency to ensure that the critical
factor was within the limits specified in the scheduled process. Specifically, ***
When the finished equilibrium pH of the food was above 4.0, [you did not use a potentiometer to
measure the finished equilibrium pH] [you did not ensure that the in-process measurements by titration
or colorimetry were related to the finished equilibrium pH]. Specifically, ***
The packing period is not changed often enough to enable ready identification of lots during sale and
distribution Specifically, ***
Appropriate training in food handling techniques and food protection principles has not been provided
to [food handlers] [supervisors]. Specifically, ***
The capper efficiency for glass containers with vacuum closures was not checked by a measurement of
the cold water vacuum before filling operations. Specifically, ***
For an operation that uses water during the filling of the retort or during processing, provisions were not
made to ensure that the water will not, before the start of each thermal process, lower the initial
temperature of the product below that specified in the scheduled process. Specifically, ***
You did not register with FDA with required information on Form FDA 2541 (food canning establishment
registration) within 10 days after first engaging in the manufacture, processing, and packaging a low-acid
canned food. Specifically, ***
You did not file with FDA an intentional change in a previously filed scheduled process in which the
change consisted solely of a higher initial temperature, a higher retort temperature, or a longer
processing time, and the modification was thereafter regularly scheduled. Specifically, ***
You did not prepare and maintain files on current procedures for [recalling products which may be
injurious to health] [identifying, collecting, warehousing and controlling products] [determining
effectiveness of recalls] [notifying FDA of recalls] [implementing recall programs]. Specifically, ***
For an intentional change in a previously filed scheduled process, you did not submit to FDA, within 30
days after first use, [a complete description of the modifications made and utilized] [a copy of the file
record showing prior substantiation by a qualified scientific authority as to the safety of the changed
process]. Specifically, ***
Your review of corrective action records does not [ensure that the records are complete] [verify that the
appropriate corrective actions have been taken]. Specifically, ***
Your review of [calibration] [in-process testing] [end-product testing] records does not ensure [that the
records are complete] [that the activities occurred in accordance with your written procedures]
[occurred within a reasonable time after the records were made]. Specifically, ***
Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical
control point to ensure compliance with the critical limit. Specifically,
Your [validation of the HACCP plan] [validation of the hazard analysis] was not done by an individual who
had successfully completed training in the application of HACCP principles to juice processing or
otherwise qualified through job experience to perform these function. Specifically, ***
Your review of critical control point monitoring records does not [ensure that the records are complete]
[verify that they document values that are within critical limits]. Specifically, ***
Your food facility is not registered as required. Specifically, ***
You did not [establish] [follow] written procedures for hygienic practices. Specifically, ***
Your personnel did not thoroughly [wash] [wash and sanitize] their hands in an adequate hand-washing
facility [before starting work] [at any time when the hands may have become soiled or contaminated].
Specifically, ***
You allowed [animals] [pests] in your physical plant. Specifically, ***
You did not maintain your physical plant in repair sufficient to prevent components, dietary supplements,
or contact surfaces from becoming contaminated. Specifically, ***
Air-blowing equipment was not [located] [operated] to minimize the potential for microorganisms or
particulate matter to contaminate components, dietary supplements, or contact surfaces. Specifically,
***
Your physical plant did not permit the use of proper precautions to reduce the potential for mix-ups or
contamination of components, dietary supplements, or contact surfaces, with microorganisms,
chemicals, filth, or other extraneous material. Specifically, ***
You [did not have] [did not use] separate or defined areas of adequate size or other control systems to
prevent contamination or mix-ups of components and dietary supplements during receiving, identifying,
holding, and withholding from use components, dietary supplements, packaging, and labels. Specifically,
***
You did not make and keep records that show that the water you use [complies with applicable Federal,
State, and local requirements] [does not contaminate the dietary supplement]. Specifically, ***
You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated,
mechanical, and electronic equipment. Specifically, ***
You did not perform each step in the production of a batch, according to the master production record.
Specifically, ***_x000D_
Your batch production records did not include the identity of equipment and processing lines used in
producing the batch. Specifically, ***
Your batch production records did not include documentation, at the time of performance, of the
manufacture of the batch. Specifically, ***
You did not [establish] [follow] written procedures for the requirements for product received for
packaging or labeling as a dietary supplement. Specifically, ***
You did not identify each unique lot within each unique shipment of labels in a manner that allows you
to trace the lot to [the supplier] [the date received] [the name of the labels] [the status of the labels]
[the dietary supplement that you distributed]. Specifically, ***_x000D_
You did not identify each unique lot within each unique shipment of received product in a manner that
allows you to trace the lot to [the supplier] [the date received] [the name of the received product] [the
status of the received product] [the product that you packaged or labeled and distributed as a dietary
supplement]. Specifically, ***_x000D_
_x000D_
You did not hold received product under conditions that will avoid mix-ups. Specifically, ***
You did not make and keep receiving records for [components] [packaging] [labels] [products you
received for packaging or labeling as a dietary supplement]. Specifically, ***
You did not [establish] [follow] written procedures for the tests and examinations conducted to
determine whether specifications are met. Specifically, ***
You did not [establish] [follow] laboratory control processes. Specifically, ***
You did not [establish] [follow] laboratory control processes for use of criteria for establishing
appropriate specifications. Specifically, ***
You did not [establish] [follow] laboratory control processes for use of criteria for selecting standard
reference materials used in performing tests and examinations. Specifically, ***
You did not make and keep records of the written procedures for manufacturing operations. Specifically,
***
You did not clearly [identify] [hold] [control] under a quarantine system for appropriate disposition a
dietary supplement that was rejected and unsuitable for use in manufacturing, packaging, or labeling
operations. Specifically,
You did not [establish] [follow] written procedures for manufacturing operations. Specifically, ***
The written instructions in your master manufacturing record did not include specific actions to perform
and verify points, steps, or stages in the manufacturing process where control is necessary to ensure that
the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Specifically, ***
The written instructions in your master manufacturing record did not include specific actions necessary
to perform and verify points, steps, or stages in the manufacturing process where control is necessary to
ensure the quality of the dietary supplement. Specifically, ***
The written instructions in your master manufacturing record did not include specifications for each
point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the
dietary supplement. Specifically, ***
Your master manufacturing record did not include a statement of intentional overage amount of a
dietary ingredient. Specifically, ***
Your master manufacturing record did not include the [identity] [weight or measure] of each dietary
ingredient that will be declared on the Supplement Facts label. Specifically, ***
Your master manufacturing record did not include the [name] [strength] [concentration] [weight]
[measure] of each dietary ingredient for each batch size. Specifically, ***
Your master manufacturing record did not identify specifications for the points, steps, or stages in the
manufacturing process where control is necessary to ensure that the dietary supplement is packaged
and labeled as specified in the master manufacturing record. Specifically, ***
You did not [identify] [identify by effective means] filled dietary supplement containers that are set aside
and held in unlabeled condition for future label operations, to prevent mix-ups. Specifically, ***
You did not protect manufactured dietary supplements from contamination during [filling] [assembling]
[packaging] [labeling] operations. Specifically, ***
You did not clean and sanitize [filling and packaging equipment] [utensils] [dietary supplement
packaging], as appropriate. Specifically, ***
Your [review about whether to investigate a product complaint] [findings and follow-up action of an
investigation performed] did not extend to all relevant batches and records. Specifically, ***
Your production and in-process control system is not designed to ensure that the dietary supplement is
manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary
You did not provide adequate documentation of your basis for why meeting the in-process specifications,
in combination with meeting component specifications, will help ensure that the specifications are met
for [the identity] [purity] [strength] [composition]. Specifically, ***
You did not establish specifications to [sufficiently] assure that the product you received for packaging or
labeling as a dietary supplement is adequately identified and is consistent with your purchase order.
Specifically,
You did not confirm the identity of components. Specifically, ***
You did not [conduct a visual examination of the label] [review the supplier's invoice, guarantee, or
certification] to determine whether label specifications are met. Specifically, ***
Your quality control personnel did not ensure that required representative samples are collected.
Specifically, ***
Your quality control personnel did not ensure that required reserve samples were collected and held.
Specifically, ***
You do not have quality control operations for a material review and disposition decision. Specifically,
***
Your quality control personnel did not conduct a material review and make a disposition decision when a
batch deviated from the master manufacturing record. Specifically, ***
Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] when
an established specification was not met. Specifically, ***
Your quality control operations did not include approving, and releasing from quarantine, all
[components] [packaging] [labels] before they were used. Specifically, ***
Your quality control operations did not include determining whether the finished [packaged] [labeled]
dietary supplement conforms to established specifications. Specifically, ***
Your quality control operations for returned dietary supplements did not include conducting a required
material review and making a required disposition decision. Specifically, ***
You did not make and keep documentation of your material review and disposition decision. Specifically,
***
You did not make and keep written procedures for fulfilling the requirements for equipment and utensils.
Specifically, ***
Your pullet environment is not tested for SE when pullets are 14 to 16 weeks of age. Specifically,***
You have not taken [adequate] steps to assure that there is no introduction or transfer of SE into or
among poultry houses. Specifically,***
You do not maintain practices that will protect against cross contamination when equipment is moved
among poultry houses. Specifically,***
Your poultry house was not cleaned and disinfected by appropriate procedures before new laying hens
were added to the house, when there was [an environmental test] [an egg test] that was positive for SE
at any point during the life of a flock that was housed there prior to depopulation. Specifically,***
Eggs intended to be processed as table eggs [were not held and transported as required at or below 45
deg. F] [were held at room temperature for more than 36 hours just prior to processing]. Specifically,***
Environmental testing of SE in a poultry house was not performed at 4 to 6 weeks after the end of the
molting process which followed your inducing of a molt in a flock or a group in the flock. Specifically,***
The poultry house environmental sampling plan was not appropriate to the poultry house layout.
Specifically,***
Your written SE plan does not [bear a date] [carry the signature(s) and not the initials of the person(s)
who administer the plan]. Specifically,***
A bleeder was not wide open during the entire process [including the come-up time]. Specifically, ***
For the public water system used as your source water and for which you did not conduct required
testing, you did not provide the public water system testing results, or certificates showing full
compliance with all provisions of EPA National Primary and Secondary Drinking Water Regulations
pertaining to chemical contaminants, for the source water testing requirements. Specifically, ***
You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they
were clean and suitable for processing. Specifically, ***
You did not ensure that raw materials and other ingredients were not adulterated by pathogenic
microorganisms. Specifically, ***
For a low-acid canned food, with respect to microbiological hazards that your supplier must control
according to the low-acid food regulations, you did not verify and document that the food was produced
according to the low-acid canned foods regulations. Specifically, ***
You did not approve your foreign supplier on the basis of an evaluation that you conducted of the foreign
supplier's performance and the risk posed by a food or based on a review and assessment of another
entity's evaluation or reevaluation of a foreign supplier's performance the risk posed by a food.
Specifically, ***
You did not establish written procedures for using an unapproved foreign supplier on a temporary basis.
Specifically, ***
You did not [determine] [document] the frequency of the verification activities that were needed to
provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance
with processes and procedures that provide the required level of public health protection. Specifically,
***
You did not conduct an appropriate supplier verification activity. Specifically, ***
For a food that may contain a hazard that will be controlled by the foreign supplier and is one for which
there is a reasonable probability that exposure to the hazard will result in serious adverse health
consequences or death to humans or animals, you did not conduct and document or obtain
documentation of an onsite audit of the foreign supplier [before initially importing the food into the
United States] [at least annually after importing the food into the United States]. Specifically, ***
You did not conduct and document or obtain documentation of one or more supplier verification
activities [before importing the food into the United States] [periodically after importing the food into
the United States]. Specifically, ***
You did not [sign] [date] an FSVP record [upon initial completion] [upon modification]. Specifically, ***
Your FSVP did not provide [adequate] assurances that your foreign supplier is producing the food in
compliance with processes and procedures that provide the required level of public health protection.
Specifically, ***
Your food safety plan was not signed and dated [upon initial completion] [when modified]. Specifically,
***
You did not have [complete] training records for your preventive controls qualified individual.
Specifically, ***
You did not take appropriate measures to prevent the introduction of known or reasonably foreseeable
hazards into covered produce. Specifically, ***
You did not establish and keep records that document personnel training, including [the date of training]
[training topics] [persons trained]. Specifically, ***
You did not handle harvested produce in a manner that protects against contamination with known or
reasonably foreseeable hazards. Specifically, ***
Your buildings are not suitable in [size] [construction] [design] to maintain and clean to reduce the
potential for contamination. Specifically, ***
You did not take measures to prevent the introduction of hazards onto [seeds] [beans] used for
sprouting. Specifically, ***
Surfaces used to grow, harvest, pack, or hold sprouts were not cleaned and sanitized before they came in
contact with [sprouts] [seeds] [beans]. Specifically, ***
You did not aseptically collect samples of [spent irrigation water] [in-process sprouts]. Specifically, ***
You did not [establish] [maintain] records documenting temperature controls. Specifically, ***
You did not make available for official review and copying at reasonable times [all records] [all plans and
procedures] required by the regulations. Specifically, ***
Your computerized records do not provide that appropriate controls are implemented to ensure the
integrity of the electronic data and signatures. Specifically, ***
You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be
adequate. Specifically, ***
You did not immediately return your records for official review upon demand. Specifically, ***
Suitable outer garments are not worn that protect against contamination of [food] [food contact
surfaces] [food packaging materials]. Specifically, ***
Personal [clothing] [belongings] were stored in an area where [food is exposed] [equipment or utensils
are washed]. Specifically, ***
Employees were observed to be [eating food] [chewing gum] [drinking beverages] [using tobacco] in
areas where [food is exposed] [equipment or utensils are washed]. Specifically, ***
You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP).
Specifically, ***
The [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food
with [lubricants] [fuel] [metal fragments] [contaminated water] [contaminants]. Specifically, ***
Failure to store cleaned and sanitized portable equipment in a [location] [manner] which protects food-
contact surfaces from contamination. Specifically, ***
The bottling room was not separated from other plant operations by [tight walls] [ceilings] [self-closing
doors] to protect against contamination. Specifically, ***
The [product] [operations] water [supply was] [supplies were] not from an approved source. Specifically,
***
Failure to provide sufficient space for [placement of equipment] [storage of materials] as necessary for
the maintenance of sanitary operations and the production of safe food. Specifically, ***
The critical factors identified in the schedule process for the prevention of the growth of microorganisms
not destroyed by the thermal process are not controlled in a manner to ensure the limits established are
not exceeded. Specifically, ***
You did not maintain records on file at the plant pertaining to [approval of the source water by
government agencies] [sampling and analyses for which you are responsible] [corrective measures taken
in response to a finding of Escherichia coli]. Specifically, ***
Your single-service containers, caps, or seals were not [purchased] [stored] in sanitary closures.
Specifically, ***
Your single-service containers, caps, or seals were not [examined] [washed, rinsed, and sanitized when
necessary] [handled in a sanitary manner] prior to use. Specifically, ***
The plant is not constructed in such a manner as to prevent [drip] [condensate] from contaminating
[food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width].
Specifically, ***
A critical factor that may affect the scheduled process was not specified in the scheduled process.
Specifically, ***
Scheduled processes were not readily available to the [retort or processing system supervisor] [FDA
Investigator]. Specifically, ***
No corrective action was taken, e.g. fully reprocessing or setting the lot aside for evaluation, when a
deviation from the scheduled process was found. Specifically, ***
You did not have a deviation from the scheduled process evaluated for public health significance by a
competent processing authority. Specifically, ***
An entry on a [processing record] [production record] was not made by the retort or processing system
operator or other designated person. Specifically, ***
Failure to properly [identify] [hold] [store] toxic [cleaning compounds] [sanitizing agents] [pesticide
chemicals] in a manner that protects against contamination of [food] [food-contact surfaces] [food-
packaging materials]. Specifically, ***
Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against
contamination. Specifically, ***
Sanitizing agents are [inadequate] [unsafe] under conditions of use. Specifically, ***
The [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of
[food] [food-contact surfaces] [water supplies] [ground surfaces]. Specifically, ***
Hand-washing facilities lack running water of a suitable temperature. Specifically, ***

Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate
floor drainage. Specifically, ***
Failure to provide running water [at a suitable temperature] [under suitable pressure] for [processing of
food] [cleaning of equipment, utensils and food-packaging materials] [employee sanitary facilities].
Specifically, ***
A [processing] [production] record form was not signed or initialed by a processing system operator or
other designated person. Specifically, ***
A [processing] [production] record was not reviewed [within 1 working day after the actual process]
[before shipment or release for distribution] to determine completeness of the record and to ensure that
the product received the scheduled process. Specifically, ***
Each retort did not have at least one temperature-indicating device that accurately indicated the
temperature during processing. Specifically, ***
A temperature-indicating device was not tested for accuracy [upon installation] [at least once a year] [as
frequently as necessary to ensure accuracy during processing]. Specifically, ***
The reference instrument for indicating the processing temperature was not a temperature-indicating
device. Specifically, ***
Failure to hold foods which can support the rapid growth of undesirable microorganisms at a
temperature that prevents the food from becoming adulterated. Specifically, ***
Failure to use adequate [sterilization] [irradiation] [pasteurization] [freezing] [refrigeration] [pH control]
[water activity control] to destroy or prevent the growth of undesirable microorganisms in food.
Specifically, ***
Failure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold]
[store] food in a manner that protects against contamination. Specifically, ***
Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in
Failure to treat and maintain [batters] [breading] [sauces] [gravies] [dressings and similar preparations] in
a manner that protects against [contamination] [growth of microorganisms]. Specifically, ***
Failure to adequately [monitor pH] [maintain a pH of 4.6 or below] for foods that rely principally on the
control of pH to prevent the growth of undesirable microorganisms. Specifically, ***
A retort that used water for cooling was not equipped with a suitable valve to prevent leakage of water
into the retort during processing. Specifically, ***
Graduations on a temperature-recording device chart exceeded 2 ?F (1?C) within a range of 10 ?F (5 ?C)
of the process temperature. Specifically, ***
You did not keep records of [inspections and conditions found] [physical maintenance] [performance] for
mechanical washers. Specifically, ***
Timing of a process began [before the retort was properly vented] [before the processing temperature
was reached]. Specifically, ***
Sanitizing operations were not adequate to sanitize the intended [product water-contact surfaces]
[critical areas]. Specifically, ***
A critical factor specified in the scheduled process was not [measured] [recorded] on the processing
record [at intervals of sufficient frequency to ensure that the factor was within the limits specified in the
scheduled process]. Specifically, ***
A still retort was not equipped with an automatic steam controller to maintain the retort temperature.
Specifically, ***
Each retort did not have at least one temperature-indicating device that accurately indicated the
temperature during processing. Specifically, ***
Each retort did not have an accurate temperature-recording device. Specifically, ***
A means of preventing unauthorized adjustment to the temperature-recording device was not provided.
Specifically, ***
A retort did not have a means of determining the water level in the retort during operation. Specifically,
***
The operator did not [check] [record] the water level in the retort [at intervals sufficient to ensure its
adequacy]. Specifically, ***
You did not record and maintain information as to the [kind of product] [volume produced] [date
produced] [lot code used] [distribution of finished product to wholesale and retail outlets]. Specifically,
***
You did not [sample] [inspect] all containers and closures to ascertain they are free from contamination.
Specifically, ***
Heat distribution data or documentary proof from the retort manufacturer or from a competent
processing authority demonstrating that adequate venting is achieved in the retort was not on file.
Specifically, ***
Your treatment of product water was not done in a manner that was effective in accomplishing the
intended purpose. Specifically, ***
Failure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against
Failure to store raw materials in a manner that [protects against contamination] [minimizes
deterioration]. Specifically, ***
Failure to identify material scheduled for rework as such. Specifically, ***
nearly as possible with, but not higher than, the temperature-indicating device during processing.
Specifically, ***
Each product sterilizer did not have at least one temperature-indicating device that accurately indicated
the temperature during processing. Specifically, ***
Graduations on a temperature-recording device chart exceeded 2 ?F (1 ?C) within a range of 10 ?F (5 ?C)
of the process temperature. Specifically, ***
A flow control device was not located upstream from the holding tube. Specifically, ***
A product-sterilizing holding tube was not designed [so that no portion of the tube between the product
inlet and the product outlet could be heated] [so that it sloped upward at least 1/4-inch per foot (2.1
centimeters per meter]. Specifically, ***
The methods and controls used for the [manufacture] [processing] [packing] of a thermally processed
food were not operated or administered in a manner adequate to ensure that the product is safe.
Specifically, ***
The container and closure sterilization system was not instrumented to demonstrate that the required
sterilization is being [continuously] accomplished. Specifically, ***
Observation and measurement of an operating condition was not [made] [recorded] at intervals of
sufficient frequency to ensure that commercial sterility of the food product was being achieved.
Specifically, ***
The [media flow rates] [temperatures] [container and closure rates through the sterilizing system]
[sterilization conditions of a batch system used for container sterilization] [operating conditions] were not
[observed] [recorded]. Specifically, ***
Acidified foods are not manufactured, processed and packaged to [achieve within the time designated in
the scheduled process] [maintain] a pH value of 4.6 or lower in all finished foods. Specifically, ***
Each container is not marked with an identifying code permanently visible to the naked eye. Specifically,
***
Records identifying initial distribution of finished product are not maintained. Specifically, ***
Required records are not maintained at the processing plant or other reasonably accessible location for a
period of three years from the date of manufacture. Specifically, ***
A qualified container closure inspection person did not record visual observations of gross closure
defects. Specifically, ***
Corrective action taken for closure defects revealed during can seam teardown examinations was not
recorded. Specifically, ***
Container cooling water was not chlorinated or otherwise sanitized [for cooling canals] [for recirculated
water supplies]. Specifically, ***
Container handling equipment used in handling filled containers was not [designed] [constructed]
[operated] to preserve the can seam or other container closure integrity. Specifically, ***
Clock times on temperature-recording device records did not reasonably correspond to the time of day
on the processing records. Specifically, ***
A steam controller activated by the steam pressure of the retort was not carefully maintained
mechanically so that it operated satisfactorily. Specifically, ***
No evidence in the form of heat distribution data or other suitable information was on file to
demonstrate that heat distribution was adequate for the [retort installation] [operating procedures].
Specifically, ***
Food-contact surfaces are not made of non-toxic materials. Specifically, ***
You did not provide FDA, after written request, with the process and procedure information that FDA
deemed necessary to determine the adequacy of the process. Specifically, ***
You did not prepare, review, and retain required processing and production records [at the processing
plant or other reasonably accessible location] [for three years from the date of manufacture].
Specifically, ***
You did not provide FDA, when requested in writing, with information concerning processes and
procedures that FDA deemed necessary to determine the adequacy of the process. Specifically, ***
For an intentional change in a previously filed scheduled process, substantiation was not [promptly
recorded] [verified in writing by the authority] [placed in your files for review by FDA]. Specifically, ***
You did not review [some of] your calibration records within a reasonable time after the records were
made. Specifically, ***
You do not have records that [fully] document corrective actions that were taken. Specifically, ***
You do not have written procedures that describe [product specifications] [affirmative steps] to ensure
that juice you receive for import into the United States was processed in accordance with the juice
HACCP regulation. Specifically, ***
You do not [always] correct deficiencies from good manufacturing practice in a timely manner.
Specifically, ***
You did not evaluate [product ingredients] [processing procedures] [packaging] [storage] [intended use]
[facility and equipment function and design] [plant sanitation, including employee hygiene] to determine
the potential effect on the safety of the finished food for the intended consumer. Specifically, ***
You do not process and perform final product packaging in a single facility operating under current good
manufacturing practices. Specifically, ***
You did not analyze product water samples as often as necessary to assure uniformity and effectiveness
of the treatment processes performed by the plant. Specifically, ***
You did not retain at the plant current certificates or notifications of approval issued by the government
agency or agencies approving the source and supply of [product water] [operations water]. Specifically,
***
You did not inspect mechanical washers [as often as necessary] to assure adequate performance.
Specifically, ***
Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical
control points. Specifically, ***
Your computerized records do not provide that appropriate controls are implemented to ensure the
integrity of the electronic data and signatures. Specifically, ***
You did not [establish] [follow] written procedures for preventing microbial contamination from sick or
infected personnel. Specifically, ***
You did not [establish] [follow] written procedures for determining personnel qualification requirements.
Specifically, ***
Your personnel [ate food] [chewed gum] [drank beverages] [used tobacco products] in areas where
components, dietary supplements, or contact surfaces are exposed or where contact surfaces are
washed. Specifically, ***
Each supervisor you use is not qualified by education, training, or experience to supervise. Specifically,
***
You did not keep the records required for personnel for the required time period. Specifically, ***
Your training documentation did not include the [date of the training] [type of training] [persons
trained]. Specifically, ***
You did not provide your employees with [adequate] [readily accessible] bathrooms. Specifically, ***
Water that was used a manner such that the water may become a component of a dietary supplement
did not comply with applicable [Federal] [State] [local] requirements. Specifically, ***
You did not [properly store equipment] [remove litter and waste] [cut weeds or grass] within the
immediate vicinity of the physical plant. Specifically, ***
You did not use cleaning compounds that [are free from microorganisms of public health significance]
[are safe and adequate under the conditions of use]. Specifically, ***
You did not [identify] [hold] cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or
other toxic materials in a manner that protects against contamination of components, dietary
supplements, or contact surfaces. Specifically, ***
The plumbing in your physical plant was not adequate to carry sufficient amounts of water to required
locations throughout the physical plant. Specifically, ***
Your [floors] [walls] [ceilings] were not designed and constructed so they can be adequately cleaned and
kept clean and in good repair. Specifically, ***
Your physical plant did not have aisles or working spaces between equipment and walls that are
[adequately unobstructed] [of adequate width] to permit all persons to perform their duties and to
protect against contamination of components, dietary supplements, or contact surfaces with clothing or
personal contact. Specifically, ***
You [did not have] [did not use] separate or defined areas of adequate size or other control systems to
prevent contamination or mix-ups of components or dietary supplement by separating the
[manufacturing] [packaging] [labeling] [holding] of different product types. Specifically, ***
You [did not have] [did not use] separate or defined areas of adequate size or other control systems
prevent contamination or mix-ups of components or dietary supplements during holding operations.
Specifically, ***
You used equipment or utensils that were not of appropriate design and construction so that the use
resulted in contamination of components or dietary supplements. Specifically, ***
Your equipment or utensils are not designed or constructed to withstand [the environment in which they
are used] [the action of components or dietary supplements] [cleaning compounds and sanitizing
agents]. Specifically, ***
Your equipment or utensils are not maintained to protect components and dietary supplements from
being contaminated. Specifically, ***
Your freezer, refrigerator, or other cold storage compartment that you use to hold components or dietary
supplements does not have an indicating thermometer, temperature-measuring device, or temperature-
recording device that indicates and records, or allows for recording by hand, the accurate temperature
within the compartment. Specifically, ***
Your freezer, refrigerator, or other cold storage compartments that you use to hold components or
dietary supplements does not have either an automated device for regulating temperature or an
automated alarm system to indicate a significant temperature change. Specifically, ***
The compressed air or other gases you introduced mechanically into or onto a component, dietary
supplement, or contact surface or that you used to clean any contact surface was not treated in such a
way that the component, dietary supplement, or contact surface is not contaminated. Specifically, ***
Cleaning compounds or sanitizing agents were not [adequate for their intended use] [safe under their
conditions of use]. Specifically, ***
You did not [establish] [use] appropriate controls for automated, mechanical, or electronic equipment to
ensure that changes [are approved by quality control personnel] [are instituted only by authorized
personnel]. Specifically, ***
You did not [establish] [use] appropriate controls to ensure that your automated, mechanical, or
electronic equipment functions in accordance with its intended use. Specifically, ***
Your batch production records did not include the unique identifier that you assigned to [a component]
[a product that you received from a supplier for packaging or labeling as a dietary supplement] [the
packaging used] [the label used]. Specifically, ***
Your batch production records did not include documentation that the finished dietary supplement
meets established specifications. Specifically, ***
Your batch production records did not include initials of the person responsible for verifying the addition
of components to the batch. Specifically, ***
Your batch production records did not include [the unique identifier assigned to packaging used] [the
quantity of the packaging used]. Specifically, ***
Your batch production records did not include [the unique identifier assigned to labels used] [the
quantity of the labels used] [reconciliation of discrepancies between issuance and use of labels].
Specifically, ***
Your batch production records did not include the results of any tests or examinations conducted on
packaged and labeled dietary supplements or a cross-reference to the physical location of such results.
Specifically, ***
Your batch production records did not include documentation that quality control personnel approved
and released, or rejected, a batch for distribution. Specifically, ***
Your batch production records did not include documentation [at the time of performance] of a required
material review and disposition decision. Specifically, ***
You did not hold components under conditions that will [protect against contamination] [protect against
deterioration] [avoid mix-ups]. Specifically, ***
Your quality control personnel did not approve packaging for use in the manufacture of a dietary
supplement and release it from quarantine. Specifically, ***
Your quality control personnel did not approve labels for use in the manufacture of a dietary supplement
and release them from quarantine. Specifically, ***
You did not quarantine received product. Specifically, ***
You did not make and keep documentation that the requirements that apply to production and process
control for components of dietary supplements were met. Specifically, ***
control for components of dietary supplements were met. Specifically, ***
control for product received for packaging or labeling as a dietary supplement were met. Specifically,
***
The person who performed a required operation did not document, at the time of performance, that the
required operation was performed. Specifically, ***
Your documentation of a required operation did not include the results of [tests or examinations
conducted on components, packaging, or labels] [visual examination of product that you received for
packaging or labeling as a dietary supplement]. Specifically, ***
Your reserve sample of a dietary supplement was not held using the same container-closure system in
which the packaged and labeled dietary supplement was distributed. Specifically, ***
You did not hold reserve samples [under conditions consistent with product labels] [under ordinary
storage conditions]. Specifically, ***
Your reserve sample of a dietary supplement that was distributed to be packaged and labeled was not
held using a container-closure system that provides essentially the same characteristics to protect against
contamination or deterioration as the one in which it was distributed for packaging and labeling
elsewhere. Specifically, ***
You did not retain reserve samples for the required time. Specifically, ***
You did not distribute a dietary supplement under conditions that protect the dietary supplement against
contamination and deterioration. Specifically, ***
You did not [establish] [follow] sampling plans for obtaining representative samples of finished batches
of dietary supplements. Specifically, ***
You did not keep the records required for your laboratory operations for the required time period.
Specifically, ***
You did not keep the records required for your laboratory operations as original records, true copies, or
as electronic records. Specifically, ***
You did not make and keep documentation that established laboratory methodology was followed.
Specifically, ***
The person who conducted the testing and examination did not document [at the time of performance]
that established laboratory methodology was followed. Specifically, ***
The documentation for laboratory tests and examinations did not include the results of the testing and
examination. Specifically, ***
You did not conduct manufacturing operations in accordance with adequate sanitation principles.
Specifically, ***
The written instructions in your master manufacturing record did not include specifications for each
point, step, or stage in the manufacturing process where control is necessary to ensure that the dietary
supplement is packaged and labeled as specified in the master manufacturing record. Specifically, ***
Your master manufacturing record did not include a complete list of components to be used. Specifically,
***
You did not clearly [identify] [hold] [control] under a quarantine system for appropriate disposition
packaged and labeled dietary supplement rejected for distribution. Specifically, ***
You were not able to determine the complete manufacturing history and control of a packaged and
labeled dietary supplement through distribution. Specifically, ***
You did not examine, before [packaging] [labeling] operations, [packaging] [labels] for each batch of
dietary supplement to determine whether the [packaging] [labels] conformed to the master
manufacturing record. Specifically, ***
Your review and investigation of a product complaint did not extend to all relevant batches and records.
Specifically, ***
You did not keep the records required for product complaints for the required time period. Specifically,
***
You did not make and keep a written record of every product complaint that was related to good
manufacturing practice. Specifically, ***
The person who performed a requirement relating to product complaints did not document, at the time
of performance, that the requirement was performed. Specifically, ***
The written record of a product complaint did not include the name and description of the dietary
The written record of a product complaint did not include the batch, lot, or control number of the dietary
You did not implement a system of production and process controls that covers all stages of
manufacturing, packaging, labeling, and holding of dietary supplements to ensure that the dietary
supplement is [packaged] [labeled] as specified in the master manufacturing record. Specifically, ***
Your production and in-process control system was not reviewed and approved by quality control
personnel. Specifically, ***
You did not establish in-process specifications for a point, step, or stage in the master manufacturing
record where control is necessary for limits on contamination that may adulterate or may lead to
adulteration of the finished dietary supplement. Specifically, ***
You did not determine whether you met specifications established to ensure that the dietary supplement
is packaged and labeled as specified in the master manufacturing record. Specifically, ***
You did not determine whether you met established component specifications established to ensure the
[purity] [strength] [composition] of dietary supplements manufactured using the components.
Specifically, ***
You did not determine whether you met established limits on contamination that may adulterate or may
lead to adulteration of the finished batch of the dietary supplement. Specifically, ***
You did not determine whether you met established limits on contamination that may adulterate, or that
may lead to adulteration of, the finished batch of the dietary supplement. Specifically, ***
You did not monitor the in-process points, steps, or stages, where control is necessary to ensure that the
quality of the finished batch of dietary supplement, to determine whether the in-process specifications
are met. Specifically, ***
You did not establish a corrective action plan to use when an established specification is not met.
Specifically, ***
Your quality control personnel did not reject a component that did not meet an identity specification.
Specifically, ***
You did not collect representative samples of each unique lot of [components] [packaging] [labels] that
you used to determine whether the [components] [packaging] [labels] meet(s) established specifications.
Specifically, ***
You did not collect representative samples [of a subset] of finished batches of dietary supplements that
you manufacture [before releasing for distribution] to verify that the finished batch of dietary
supplement meets established product specifications. Specifically, ***
You did not collect representative samples of [each unique shipment] [each unique lot within each
unique shipment] product that you received for packaging or labeling as a dietary supplement to
determine whether the received product meets established specifications. Specifically, ***
You did not retain reserve samples for the required time. Specifically, ***
Your reserve sample did not consist of at least twice the quantity necessary for all tests or examinations
to determine whether or not the dietary supplement meets product specifications. Specifically, ***
You reprocessed a dietary supplement for which quality control personnel did not [conduct a material
review] [make a disposition decision to approve the reprocessing]. Specifically, ***
Your quality control personnel did not ensure that the dietary supplement is [packaged] [labeled] as
specified in the master manufacturing record. Specifically, ***
why meeting in-process specifications, in combination with meeting component specifications, will help
ensure that the identity, purity, strength, and composition of the dietary supplement are met.
Specifically, ***
Your quality control personnel did not determine that specifications established for the production and
process control system were met. Specifically, ***
Your quality control personnel did not perform required operations for the production and process
control system. Specifically, ***
Your quality control personnel did not perform required operations for [components] [packaging] [labels]
before use in the manufacture of a dietary supplement. Specifically, ***
Your quality control personnel did not perform required operations for [packaging] [labeling] operations.
Specifically, ***
You do not have quality control operations for laboratory operations associated with the production and
process control system. Specifically, ***
Your quality control operations did not include ensuring that [tests] [examinations] required for your
laboratory operations were conducted. Specifically, ***
Your quality control personnel did not conduct a material review and make a disposition decision for an
unanticipated occurrence during the manufacturing operations that adulterated or may lead to
adulteration of the [component] [dietary supplement] [packaging]. Specifically, ***
Your quality control personnel did not reject the dietary supplement when there was a deviation or
unanticipated occurrence during the production and in-process control system that [resulted in] [could
lead to] adulteration of the dietary supplement. Specifically, ***
Your quality control operations did not include periodically reviewing all records for calibration of
instruments and controls. Specifically, ***
Your quality control operations did not include approving or rejecting reprocessing. Specifically, ***
Your quality control operations did not include approving and releasing, or rejecting, each finished batch
for distribution. Specifically, ***
Your quality control operations for packaging did not include reviewing the results of [visual
examinations] [documentation] to ensure that established specifications were met for products that you
receive for packaging. Specifically, ***
Your quality control operations for labeling did not include approving or rejecting any relabeling of a
packaged and labeled dietary supplement. Specifically, ***
Your quality control operations for packaging and labeling did not include approving for release, or
rejecting, any packaged and labeled dietary supplement. Specifically, ***
You do not have quality control operations for product complaints. Specifically, ***
You did not keep the records required for your quality control operations as original records, true copies,
or as electronic records. Specifically, ***
Your documentation of your material review and disposition decision and follow-up did not include a
description of your investigation into the cause of the deviation from the specification or of the
unanticipated occurrence. Specifically, ***
Your documentation of your material review and disposition decision and follow-up did not include an
explanation of what you did with the component, dietary supplement, packaging, or label. Specifically,
***
You did not keep required written records for 1 year past the shelf life date or for 2 years beyond the
date of distribution of the last batch of dietary supplements associated with the records. Specifically, ***
You did not have required records, or copies of such records, readily available during the retention period
for inspection and copying by FDA when requested. Specifically, ***
You did not [establish] [follow] written procedures for when a returned dietary supplement may be
salvaged. Specifically, ***
You did not [establish] [follow] written procedures for quality control personnel to approve a returned
dietary supplement for reprocessing. Specifically, ***
You salvaged a returned dietary supplement for which quality control personnel did not conduct a
material review and make a disposition decision to allow the salvage. Specifically, ***
You did not make and keep written procedures for calibrating instruments or controls that you use in
[manufacturing] [testing] a component or dietary supplement. Specifically, ***
You did not make and keep written procedures for [calibrating] [inspecting] [checking] automated,
mechanical, or electronic equipment. Specifically, ***
You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] contact surfaces
that are used to manufacture, package, label, or hold components or dietary supplements. Specifically,
***
Your calibration documentation did not [identify the instrument or control calibrated] [provide the date
of calibration] [identify the reference standard used] [include the certification of accuracy of the known
reference standard] [include a history of recertification of accuracy of a known reference standard]
[identify the calibration method used] [include appropriate limits for accuracy and precision] [provide
the calibration reading or readings found] [identify the recalibration method used] [identify the reading
or readings of recalibration found if the accuracy or precision limits were not met] [include the initials of
the person who performed the calibration or recalibration]. Specifically, ***
You did not make and keep documentation of the controls you use to ensure that equipment functions
according to its intended use. Specifically, ***
You did not maintain records related to [each reportable food report received] [each notification made of
a reportable food] [each reportable food report submitted to FDA] as required. Specifically, ***
All records are not retained for 1 year after the flock to which they pertain has been taken permanently
out of production. Specifically,***
You do not have a written SE prevention plan. Specifically,***
You did not maintain records documenting compliance with cleaning and disinfection procedures
performed at depopulation. Specifically,***
You did not maintain records documenting compliance with environmental and egg sampling
procedures. Specifically,***
You are not able to retrieve and provide the records at your place of business within 24 hours of request
for official review. Specifically,***
All required records do not include [your name] [the location of your farm]. Specifically,***
A [processing] [production] record was not reviewed by a representative of plant management [qualified
by suitable training or experience] to determine [completeness of the record] [whether the product
received the scheduled process]. Specifically, ***
Electronic records did not comply with the requirements for maintaining electronic records. Specifically,
***
A temperature-indicating device was not accurate to 1 ?F (0.5 ?C). Specifically, ***
A reference device was not tested for accuracy once a year or more frequently when necessary to ensure
accuracy. Specifically, ***
A temperature-indicating device was defective or could not be adjusted to an accurate calibrated
reference device. Specifically, ***
A bleeder was not wide open during the entire process [including the come-up time]. Specifically, ***
A temperature-recording device did not have a mechanism for recording temperatures to a permanent
record. Specifically, ***
The temperature recorded by the temperature-recording device in the holding tube outlet was not
[observed] [recorded] at intervals of sufficient frequency to ensure that these values were as specified in
the scheduled process. Specifically, ***
A critical factor was not measured with an instrument having the accuracy and dependability adequate
to ensure that the requirements of the scheduled process were met. Specifically, ***
The methods and controls used for the [manufacture] [processing] [packing] of a low-acid food [was not]
[were not] as established in the scheduled process. Specifically, ***
A system for processing a low-acid food in hermetically sealed containers was not operated and
administered in a manner adequate to ensure that commercial sterility was achieved. Specifically, ***
After you detected coliform organisms in your [product] [operations] source water, you did not conduct
follow-up testing to determine whether any of the coliform organisms were Escherichia coli. Specifically,
***
Air under pressure that was directed at a product water-contact surface was not free of [oil] [dust] [rust]
[excessive moisture] [extraneous materials]. Specifically, ***
Your container sample results indicated [that more than one sample exceeded more than one bacteria
per milliliter of capacity or one colony per square_x000D_
centimeter of surface area] [the presence of coliform organisms]. Specifically, ***
You have prepared, packed or held shell eggs under insanitary conditions whereby [they may have
become contaminated with filth] [they may have been rendered injurious to health]. Specifically, ***
You did not take and analyze samples of operations water [as often as necessary] [at least once every
year for chemical contamination] [at least once every four years for radiological contaminants].
Specifically, ***
During a field examination of food products at your facility the following [was] [were] observed:
You mixed adulterated food with another lot of food. Specifically, ***
You did not [review] [assess] the hazard analysis conducted by another entity. Specifically, ***
You did not [reevaluate] [document your reevaluation of] the risk posed by a food and the foreign
supplier's performance during or at the end of a 3-year period. Specifically, ***
An onsite audit of a foreign supplier did not [consider an applicable food safety regulation] [include a
review of the supplier's written food safety plan and its implementation]. Specifically, ***
For an onsite audit, you did not retain documentation [of the audit procedures] [of the dates the audit
was conducted] [of any corrective actions taken in response to significant deficiencies identified during
the audit] [that the audit was conducted by a qualified auditor]. Specifically, ***
You did not retain documentation that you conducted a foreign supplier verification activity. Specifically,
***
Your documentation of a foreign supplier verification activity did not include [a description of the
activity] [the date on which it was conducted] [the findings or results of the activity] [corrective actions
taken in response to significant identified deficiencies] [documentation that the activity was conducted
by a qualified individual]. Specifically, ***
You did not make a required FSVP record available [promptly] to an authorized FDA representative upon
request. Specifically, ***
You did not retain records as required. Specifically, ***
You did not [promptly] provide records for [review] [copying]. Specifically, ***
For a food for which you relied on your customer to significantly minimize or prevent an identified
hazard, you did not disclose in documents accompanying the food that the food is "not processed to
control {identified hazard}". Specifically, ***
For a food you imported from a small foreign supplier, you did not obtain written assurance that the
foreign supplier met the criteria of a small foreign supplier [before first approving the supplier for an
applicable calendar year] [on an annual basis by December 31 of each calendar year]. Specifically, ***
You did not obtain from your foreign supplier, who is a qualified facility, written assurances that the food
from the supplier was produced in compliance with the applicable FDA food safety regulations [before
importing the food] [at least every 2 years after initially importing the food]. Specifically, ***
You did not retain an FSVP record relating to your processes and procedures for 2 years after its use was
discontinued. Specifically, ***
In approving your small foreign supplier, you did not [evaluate] [document your evaluation of] the
applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with
those regulations. Specifically, ***
You did not maintain a cold storage area for [an in-process infant formula] [a final infant formula] at a
temperature not to exceed 45 ?F (7.2 ?C) for a defined period of time. Specifically, ***
You did not test a representative sample of a production aggregate of a powdered infant formula [at the
final product stage] [before distribution] to ensure that the production aggregate meets the required
microbiological quality standards. Specifically, ***
A premix supplier's records did not include [the results of tests to determine the purity of each nutrient
listed in the premix certificate or guarantee] [the weight of each added nutrient] [the results of any
quantitative tests conducted to determine the amount of each nutrient certified or guaranteed] [the
results of any quantitative tests conducted to identify the nutrient levels present when the nutrient
premix exceeds its expiration date or shelf life (retest date)]. Specifically, ***
You did not maintain [a certification of accuracy of a known reference standard that was used] [a history
of recertification]. Specifically, ***
Your corrective action procedures for allergen controls were not adequate. Specifically, ***
You did not [establish] [implement] adequate written procedures for monitoring your controls.
Specifically, ***
You did not have controls monitoring records. Specifically, ***
Your corrective action procedures for your controls were not adequate. Specifically, ***
Your controls records [were not reviewed by a preventive controls qualified individual or such review was
not overseen by a preventive controls qualified individual] [were not reviewed within specified
timeframes]. Specifically, ***
You did not provide adequate training at sufficient frequency to [all personnel who handle covered
produce or food contact surfaces] [personnel who supervise personnel who handle covered produce or
food contact surfaces]. Specifically, ***
You did not deliver your agricultural water treatment in a manner to ensure that the water is of sufficient
quality for its intended use. Specifically, ***
You did not ensure that agricultural water met the standard of no detectable Escherichia coli when used
[for sprout irrigation] [for direct contact during or after harvest activities] [on food contact surfaces] [for
washing hands during or after harvest activities]. Specifically, ***
You did not [maintain] [clean] non-food-contact surfaces of equipment and tools that you use during
harvesting, packing, and holding as frequently as necessary to protect against the contamination of
produce. Specifically, ***
You did not ensure that equipment that is likely to come into contact with produce does so in a manner
that minimizes the potential for the contamination of produce or food contact surfaces with known or
reasonably foreseeable hazards. Specifically, ***
You did not ensure that instruments you use are [accurate and precise] [adequately maintained]
[adequate in number]. Specifically, ***
You did not provide adequate drainage in all areas where normal operations release or discharge water
or other liquid waste to the ground or floor of buildings. Specifically, ***
You did not convey, store, and dispose of trash, litter and waste to [minimize the potential to attract or
harbor pests] [protect against contamination]. Specifically, ***
Your plumbing [is not of adequate size and design] [is not adequately installed and maintained].
Specifically, ***
You did not visually examine [seeds] [beans] [packaging used to ship seeds] [packaging used to ship
beans] for signs of potential contamination with known or foreseeable hazards. Specifically, ***
You did not test sprouts from each production batch of sprouts at the in-process stage for [E. coli
O157:H7] [Salmonella][pathogens reasonably necessary to minimize risk of serious adverse health
consequences]. Specifically, ***
Your written sampling plan did not ensure that the collected samples are representative of the
production batch. Specifically, ***
You allowed sprouts to enter commerce [prior to receipt of negative pathogen test results] [after receipt
of positive pathogen test results]. Specifically, ***
You did not document the results of all analytical tests conducted. Specifically, ***
Your required records [did not include all necessary information] [were not created at the time the
activity was performed or observed] [were not accurate] [were not legible] [were not indelible] [were
not dated and signed by the person who performed the activity]. Specifically, ***
The onsite audit of your supplier did not include [a review of the supplier's written plan]
[implementation of the supplier's written plan] for control of the hazard. Specifically, ***
You did not take appropriate action after you became aware of a possible material failure of temperature
control or other conditions that may render the food unsafe during transportation. Specifically, ***
You did not conduct a transportation operation under conditions and controls necessary to prevent the
food from becoming unsafe during transportation operations. Specifically, ***
You did not take appropriate action after you became aware of a possible material failure of temperature
control or other conditions that may render the food unsafe during transportation. Specifically, ***
You did not [develop] [implement] written procedures to ensure the safety of food during transportation.
Specifically, ***
You did not conduct a transportation operation under conditions and controls necessary to prevent the
food from becoming unsafe during transportation operations. Specifically, ***
You did not ensure that raw materials and other ingredients were not adulterated by natural toxins prior
to use. Specifically, ***
Frequency
298
226
222
195
193
182
178
174
166
164
130
126
120
105
92
91
90
80
77
77
76
76
75
73
71
66
60
59
55
54
54
51
49
47
46
44
44
44
44
43
42
42
41
39
39
38
37
37
36
36
35
35
34
33
33
31
31
29
28
27
26
26
25
25
24
24
24
24
24
23
23
22
21
20
20
19
19
19
19
18
18
17
17
17
17
17
16
16
16
16
15
15
15
15
15
15
15
14
14
14
14
14
13
13
12
12
12
12
12
12
11
11
11
11
11
11
11
11
11
11
11
11
10
10
10
10
10
10
10
10
10
10
10
9
9
8
8
7
7
6
6
6
6
5
5
5
5
4
4
4
4
4
4
3
3
3
3
3
3
3
3
3
3
2
2
2
2
2
2
2
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Human Tissue for 12277 21 CFR 1271.75(a)(1)

Transplantation
Human Tissue for 12213 21 CFR 1271.47(a)
Transplantation

Transplantation

Transplantation

Transplantation

Transplantation
Human Tissue for 12416 21 CFR 1271.260(e)
Transplantation

Transplantation

Transplantation
Human Tissue for 12493 21 CFR 1271.90(c)

Transplantation
Transplantation
Transplantation
Human Tissue for 12286 21 CFR 1271.80(b)
Transplantation
Human Tissue for 12231 21 CFR 1271.50(b)(1)

Transplantation

Transplantation
Human Tissue for 12282 21 CFR 1271.75(d)

Transplantation

Transplantation
Transplantation

Transplantation

Transplantation

Transplantation
Human Tissue for 12433 21 CFR 1271.265(f)

Transplantation

Transplantation
Human Tissue for
Transplantation 12247 21 CFR 1271.55(d)(2)

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation
Human Tissue for 12246 21 CFR 1271.55(d)(1)(iii)

Transplantation
Transplantation

Transplantation

Transplantation
Transplantation

Transplantation
Human Tissue for 12384 21 CFR 1271.215

Transplantation

Transplantation

Transplantation
Transplantation
Human Tissue for 12426 21 CFR 1271.265(c)(2)

Transplantation

Transplantation

Transplantation
Transplantation

Transplantation

Transplantation
Transplantation
Transplantation

Transplantation
Human Tissue for 12245 21 CFR 1271.55(d)(1)(ii)

Transplantation
Human Tissue for 12250 21 CFR 1271.55(d)(4)

Transplantation

Transplantation

Transplantation
Human Tissue for 12301 21 CFR 1271.150(c)(1)(iii)

Transplantation

Transplantation

Transplantation

Transplantation
Transplantation

Transplantation

Transplantation

Transplantation
Transplantation
Transplantation

Transplantation
Transplantation
Transplantation
Transplantation
Transplantation
Transplantation
Transplantation
Transplantation

Transplantation

Transplantation

Transplantation
Transplantation

Transplantation

Transplantation

Transplantation

Transplantation
Transplantation

Transplantation

Transplantation

Transplantation
Transplantation

Transplantation

Transplantation

Transplantation

Transplantation
Transplantation
Human Tissue for
Transplantation 15025 21 CFR 1271.85(b)(2)
Short Description
Risk factors, clinical evidence
Testing, screening, donor eligibility procedures
Procedures for all other requirements
Determination based on screening and testing
Procedures to meet core CTGP
Infection with communicable disease agents
Storage temperatures recorded, maintained
Records incomplete
Procedures re complaints
Eligibility not required--warning labels
Cleaned, sanitized per established schedules
Responsible person to determine, document
Specimen collections not timely
Donor screening standards
Listing and interpretation of CD tests performed
Donors with risks not determined ineligible
Name and personal info on accompanying records

All core requirements covered in program
Calibration procedures and schedules (general)
Corrective actions
Procedures and release criteria
Return to inventory--procedures
Design of procedures to ensure compliance
Accurate, indelible, legible
Labeled re: biohazard, risks, test results
Manufacturer instructions not followed
Procedures inadequate
Validation & approval--established procedures
SOP for release; reactive for CMV
Summary--records used to make determination
Statement re: certified testing lab
Name and address on summary
Reasons for ineligibility on summary
Documentation--determination, by whom, date

Kits not FDA approved, specifically labeled
Ensuring appropriate core requirements followed
Deviations--Investigation, documenting, trending
State of repair
Control system
Potential problems with recovery
Reduced risk representation
Storage temperatures appropriate
Periodic review of temperatures
Improperly released for distribution
Documentation elements for activities
Records maintained concurrently
Accurate, indelible, legible
Retention time (10 year rules)
Review and approval of procedures
Identification code affixed to container

Personal information included in I.D. code
Eligibility statement--basis of determination
Results, interpretation of CD screening
Ten year retention
Statement of restrictions
Risks associated with xenotransplantation
Ensurane of compliance
Program is appropriate for the HCT/Ps
Deviations--evaluation, cause, corrective action
Documentation/approval prior to implementation
Sufficient number
Adopted from another organization
Size, construction, location--prevent mix-ups etc.
Clean, sanitary, orderly manner
Procedures for cleaning, sanitation
Documentation of activities
Adequate control, proper conditions

Temperature and humidity controls
Monitoring-microorganisms where appropriate
Documentation not maintained
Calibrated per established schedules
Inspected routinely
Verification elements
Lot documentation maintained
Causing contamination, increasing risks
Process validation procedures
Changes to validated process
Controlling the labeling of HCT/Ps
Contamination, mix ups, improper release
Release criteria verified, documented
Management system re: core CGTPs
Prompt retrieval from multiple locations
HCT/Ps not tracked
Establishing a system
Documenting disposition of each HCT/P
Designated complaint file

Sufficient information to draw conclusions
Adverse reaction reporting to FDA
15 day reporting timeframe
Deviations not reported to FDA
Documentation of maintenance and cleaning
Documentation of use
Cytomegalovirus (CMV)
Long Description
Donors were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of
communicable disease agents and diseases. Specifically, ***
You did not establish and maintain procedures for [testing] [screening] [determining the eligibility] of
HCT/P donors. Specifically, ***
You did not establish and maintain procedures that address [the accompanying records after the donor
eligibility determination is complete] [the retention of records related to testing, screening, and
determining of donor eligibility] [storage of product from ineligible donors] [cases of use due to urgent
medical need] [limited use of product from ineligible donors] [cases of nonclinical use] [cases of use
when the donor eligibility determination is not required or there is an exception for reproductive use] of
HCT/Ps. Specifically, ***
HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Specifically, ***
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the
manufacture of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented]
[followed] [reviewed] [revised]. Specifically, ***
Donors were not tested for evidence of infection with relevant communicable disease agents.
Specifically, ***
Storage temperatures of HCT/Ps were not [recorded] [maintained]. Specifically, ***
Records [did not identify the person performing the work] [did not show the dates of entries] [were not
detailed as necessary to provide a complete history of work performed] [did not relate to the HCT/P
involved]. Specifically, ***
Procedures for the [review] [evaluation] [documentation] [investigation] of complaints relating to core
CGTP requirements were not [established] [maintained] [defined] [documented] [implemented]
HCT/Ps for which the donor eligibility determination was not performed were not prominently labeled
with the appropriate warning statements. Specifically, ***
Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained] according to
established schedules. Specifically, ***
The eligibility of an HCT/P donor was not [determined] [documented] by a responsible person, based on
results of donor screening and donor testing. Specifically, ***
Donor specimens used for testing of communicable disease agents were not collected at the appropriate
time. Specifically, ***
Donor screening of HCT/P donors considered eligible indicated that the donor was not free of [risk
factors for infection due to communicable disease agents] [clinical evidence of infection due to
communicable disease agents] [risk factors associated with xenotransplantation]. Specifically, ***
The summary of records for HCT/Ps did not contain [a listing] [an interpretation of results] of all
communicable disease tests performed. Specifically, ***
Donors were not determined to be ineligible that had [risk factors or clinical evidence of communicable
disease agents] [communicable disease risks associated with xenotransplantation]. Specifically, ***
The accompanying records for HCT/Ps included [the donor's name] [personal information that might
identify the donor]. Specifically, ***
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps
manufactured and the manufacturing steps performed, has not been [established] [maintained]
[defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
The [procedures] [schedules] for the calibration of equipment used for [inspection] [measuring] [testing]
were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed]
[revised]. Specifically, ***
Corrective actions were not [performed] [documented] when proper storage conditions were not met.
Specifically, ***
Procedures including release criteria for activities relating to the [receipt] [shipment] [distribution] of
HCT/Ps were not [established] [maintained] [documented] [implemented] [followed] [reviewed]
Procedures for determining if HCT/Ps that were returned to the establishment are suitable to be
returned to inventory were not [established] [maintained] [defined] [documented] [implemented]
Procedures were not designed to ensure compliance with the donor eligibility requirements. Specifically,
***
Donor eligibility records are not [accurate] [indelible] [legible]. Specifically, ***
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled
with [the Biohazard legend] [a statement warning of communicable disease risks] [a statement warning
of the reactive test results]. Specifically, ***
Testing for communicable disease agents was not performed in accordance with the manufacturer's
instructions. Specifically, ***
Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established]
[maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, ***
Processes with results which could not be fully verified by inspection and tests, were not validated and
approved according to established procedures. Specifically, ***
A standard operating procedure for the release of HCT/Ps from donors that test reactive for
cytomegalovirus (CMV) was not [established] [maintained] [defined] [documented] [implemented]
After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the
summary of the records used to make the donor-eligibility determination. Specifically, ***
The summary of records for HCT/Ps did not contain a statement that the communicable disease testing
was performed by a laboratory certified to perform such testing on human specimens under the Clinical
Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for
Medicare and Medicaid Services. Specifically, ***
The summary of records for HCT/Ps did not contain the [name] [address] of the establishment that made
the donor-eligibility determination. Specifically, ***
The summary of records for HCT/Ps from donors determined to be ineligible based on screening and
released for limited use did not contain a statement noting the reasons(s) for the ineligibility.
Specifically, ***
Documentation of [the donor-eligibility determination] [the responsible person who made the donor-
eligibility determination] [the date of the donor-eligibility determination] was not maintained.
Specifically, ***
Communicable disease agent tests [were not FDA-licensed, approved or cleared donor screening tests]
[were not specifically labeled for cadaveric specimens when such a test was available and cadaveric
specimens were used] [were not FDA-licensed, approved or cleared Chlamydia trachomatis or Neisseria
gonorrhea tests labeled for detection of these organisms in an asymptomatic, low-prevalence
population]. Specifically, ***
The quality program has not ensured that appropriate procedures related to core CGTP requirements
were [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed]
[approved] [revised]. Specifically, ***
The quality program does not include [the investigation] [the documentation] [the trending] [the
reporting] of HCT/P deviations relating to core CTGP requirements. Specifically, ***
Facilities were not maintained in a good state of repair. Specifically, ***
Operations were not controlled with a system [established] [maintained] [defined] [documented]
[implemented] [followed] [reviewed] [revised] to prevent [improper labeling] [mix-ups] [contamination]
[cross contamination] [accidental exposure of HCT/Ps to communicable disease agents]. Specifically, ***
HCT/Ps were not recovered in a way [that does not cause contamination or cross contamination during
recovery] [that does not increase the risk of introduction, transmission or spread of communicable
disease]. Specifically, ***
Written representation that processing methods reduce the risk of transmission of communicable
disease by HCT/Ps was not based on a fully validated or verified process. Specifically, ***
HCT/Ps were not stored at appropriate temperatures. Specifically, ***
Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been
within acceptable limits. Specifically, ***
HCT/Ps that were [in quarantine] [contaminated] [recovered from a donor determined to be ineligible]
[recovered from a donor for whom a donor eligibility determination has not been completed]
[determined to not meet release criteria designed to prevent communicable disease transmission] were
made available for distribution. Specifically, ***
Documentation for activities related to the [receipt] [shipment] [distribution] of HCT/Ps did not include
[identification of the HCT/P and the establishment that supplied the HCT/P] [activities performed and the
results of each activity] [date(s) of activity] [quantity of HCT/P subject to the activity] [disposition of the
HCT/P (identity of consignee)]. Specifically, ***
Records were not maintained concurrently with the performance of each step. Specifically, ***
Records were not [accurate] [indelible] [legible]. Specifically, ***
Records were not retained for the appropriate length of time, [10 years after their creation] [at least 10
years after the date of administration of a particular HCT/P] [at least 10 years after the date of a
particular HCT/Ps distribution, disposition, or expiration, whichever is latest, when the date of
administration is not known] [10 years after the appropriate disposition of archived specimens of dura
mater]. Specifically, ***
Donor eligibility procedures were not [reviewed] [approved] by a responsible person before
implementation. Specifically, ***
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a distinct
identification code affixed to the HCT/P container. Specifically, ***
The distinct identification code affixed to the HCT/P container included an individual's [name] [social
security number] [medical record number]. Specifically, ***
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a
statement whether the donor has been determined to be eligible or ineligible, based on the results of
screening and testing. Specifically, ***
Documentation of [the results] [the interpretation] of all donor screening for communicable diseases
was not maintained. Specifically, *
Records pertaining to HCT/Ps were not retained [at least 10 years after the date of administration] [at
least 10 years after the date of distribution, disposition, or expiration, whichever was latest when the
date of administration of the HCT/P was unknown]. Specifically, ***
HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not
accompanied by records that stated the product must not be implanted, transplanted, infused or
transferred until completion of the donor-eligibility determination. Specifically, ***
Donors were not screened by a review of relevant medical records for disease risks associated with
xenotransplantation. Specifically, ***
You did not ensure that establishment(s) that by contract, agreement or arrangement, perform
manufacturing steps for you were in compliance with [applicable CGTP requirements prior to the
initiation of the contract, agreement of arrangement] [applicable CGTP requirements after information
became available that suggested the establishment was no longer in compliance]. Specifically, ***
A quality program appropriate for the HCT/Ps manufactured and manufacturing steps performed has
not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed]
Investigation of deviations related to core CGTP requirements did not include [a review and evaluation
of the deviation] [efforts to determine the cause of the deviation] [corrective action(s) to address the
deviation and prevent recurrence]. Specifically, ***
Computer software [validation] [verification] activities and results have not been [documented]
[approved] prior to implementation. Specifically, ***
Personnel are not sufficient to ensure compliance with the requirements. Specifically, ***
Current standard procedures adopted from another organization were [not verified to be consistent with
the requirements of the CGTP regulations] [not appropriate for your operations]. Specifically, ***
Facilities were not of suitable [size] [construction] [location] to [prevent contamination of HCT/Ps with
communicable disease agents] [ensure the orderly handling of HCT/Ps without mix-ups]. Specifically, ***
Facilities were not maintained in a [clean] [sanitary] [orderly] manner to prevent the introduction,
transmission, or spread of communicable disease. Specifically, ***
Procedures for facility cleaning and sanitation were not [established] [maintained] [defined]
[documented] [implemented] [followed] [revised]. Specifically, ***
Documentation of facility cleaning and sanitation activities was not maintained. Specifically, ***
Environmental conditions existed in which [contamination or cross contamination of HCT/Ps or

equipment] [the accidental exposure of HCT/Ps to communicable disease agents] could occur, and
[environmental conditions were not adequately controlled] [proper conditions for operations were not
provided]. Specifically, ***
Environmental controls do not provide for adequate control of [temperature] [humidity]. Specifically,
***
Environmental conditions were not monitored for microorganisms. Specifically, ***
Documentation of environmental control and monitoring activities was not maintained. Specifically, ***
Equipment used for [inspection] [measuring] [testing] was not calibrated according to established
schedules. Specifically, ***
Equipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to
maintenance schedules]. Specifically, ***
Documentation of the verification of [supplies] [reagents] did not include [test results] [a certificate of
analysis from the vendor]. Specifically, ***
Documentation of the lot of [supplies] [reagents] used in the manufacture of each HCT/P was not
maintained. Specifically, ***
HCT/Ps were not processed in a way [that does not cause contamination or cross contamination during
processing] [that does not increase the risk of introduction, transmission, or spread of communicable
disease]. Specifically, ***
Procedures to validate and approve processes that cannot be fully verified by inspection and tests were
not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].
Specifically, ***
A validated process that was changed was not [reviewed] [evaluated] [revalidated]. Specifically, **
Procedures to control the labeling of HCT/Ps were not [established] [maintained] [defined]
[documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
Storage areas and stock rooms were not controlled [to prevent mix-ups, contamination and cross
contamination of HCT/Ps, supplies and reagents] [to prevent HCT/Ps from improperly being made
available for distribution]. Specifically, ***
Release criteria were not [verified] [documented] to have been met through a review of manufacturing
and tracking records before HCT/Ps were made available for distribution. Specifically, ***_x000D_
_x000D_
A records management system relating to core CGTP requirements was not [established] [maintained]
[defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
The records management system was not designed to ensure that records stored in more than one
location can be promptly identified and retrieved. Specifically, ***
HCT/Ps are not tracked [to facilitate the investigation of transmission of communicable disease] [to take
corrective actions]. Specifically, ***
A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or
final disposition was not [established] [maintained] [defined] [documented] [implemented] [followed]
[reviewed] [revised]. Specifically, ****
A method has not been [established] [maintained] [defined] [documented] [implemented] [followed]
[reviewed] [revised] in the tracking system [to document the disposition of each HCT/P] [to permit the
prompt identification of the consignee of the HCT/P, if any]. Specifically, ***
Complaints received were not maintained in a file designated for complaints. Specifically, ***
The complaint file [did not contain sufficient information about each complaint for proper review and
evaluation] [did not include the distinct identification code of the HCT/P involved] [did not contain
sufficient information for determining whether the complaint is an isolated event or represents a trend].
Specifically, ***
Adverse reactions which involved a communicable disease related to an HCT/P made available for
distribution and were fatal or life threatening, resulted in permanent impairment or damage to the body,
or necessitated medical or surgical intervention, were not reported to FDA. Specifically, ***
Adverse reactions were not reported to FDA using form FDA 3500A within 15 calendar days of initial
receipt of information. Specifically, ***
HCT/P deviations relating to core CGTP requirements that occurred [in your establishment] [at an
establishment under contract, agreement, or arrangement with your establishment] were not reported
to FDA. Specifically, ***
Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained.
Specifically, ***
Records of the use of each piece of equipment, and the HCT/Ps manufactured with the equipment, were
not maintained. Specifically, ***
Donors of viable, leukocyte-rich cells or tissue were not tested for evidence of infection due to
cytomegalovirus (CMV). Specifically, ***
Frequency
35
20
15
13
12
10
4
4
2
2
1
1
1
1
1
1
1
Parts 1240 and 1250 7036 21 CFR 1250.67
Parts 1240 and 1250 6558 21 CFR 1250.30(d)
Parts 1240 and 1250 6564 21 CFR 1250.33(a)
Parts 1240 and 1250 6552 21 CFR 1250.28
Parts 1240 and 1250 6591 21 CFR 1250.42(a)
Parts 1240 and 1250 6570 21 CFR 1250.33(c)
Parts 1240 and 1250 6572 21 CFR 1250.34
Parts 1240 and 1250 7041 21 CFR 1250.70(a)
Parts 1240 and 1250 7053 21 CFR 1250.75(b)
Parts 1240 and 1250 7089 21 CFR 1250.82(d)
Parts 1240 and 1250 6593 21 CFR 1250.42(b)
Parts 1240 and 1250 7032 21 CFR 1250.63
Parts 1240 and 1250 7051 21 CFR 1250.75(a)
Parts 1240 and 1250 7090 21 CFR 1250.82(e)
Parts 1240 and 1250 6565 21 CFR 1250.33(a)
Parts 1240 and 1250 6580 21 CFR 1250.38(b)
Parts 1240 and 1250 6581 21 CFR 1250.38(b)
Parts 1240 and 1250 6555 21 CFR 1250.30(a)
Parts 1240 and 1250 6557 21 CFR 1250.30(c)
Parts 1240 and 1250 6579 21 CFR 1250.38(a)
Parts 1240 and 1250 6525 21 CFR 1240.86

Parts 1240 and 1250 6560 21 CFR 1250.32(a)
Parts 1240 and 1250 6563 21 CFR 1250.33(a)
Parts 1240 and 1250 6567 21 CFR 1250.33(b)
Parts 1240 and 1250 6568 21 CFR 1250.33(b)
Parts 1240 and 1250 6569 21 CFR 1250.33(b)
Parts 1240 and 1250 7042 21 CFR 1250.70(a)
Parts 1240 and 1250 7058 21 CFR 1250.79(a)
Parts 1240 and 1250 7060 21 CFR 1250.79(c)

Short Description
Prevention of contamination
Plumbing design, installation, maintenance
Maintained in good repair
Handling to avoid contamination
Backflow protection
Storage and handling after bactericidal treatment
Thermometers
Adequate and readily accessible
Sanitary sewers or alternative methods
Identification marks on tanks and piping
Connections easily cleanable, located and protected
Prevention of the spread of communicable diseases
Contamination of passenger stations
Backflow prevention - general
Adequate facilities for cleaning, bactericidal treatment
Signs
Soap, sanitary towels, water
Clean and free from flies, rodents, and other vermin
Water supply
Suitable design and construction
Lack of backflow prevention

Contamination
Easily cleaned, self-draining
Cleaning of multiuse eating and drinking utensils
Cleaning of all other utensils
Equipment kept clean
Clean and sanitary
Container construction
Daily emptying and cleaning

Long Description
Failure to [design] [construct] [maintain] [operate] servicing area [piping systems] [hydrants] [taps]
[faucets] [hoses] [buckets] [equipment] in such a manner as to prevent contamination of [drinking]
[culinary] water. Specifically, ***
Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply]
[food] [food utensils]. Specifically, ***
Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food]
[beverages] are maintained in good repair. Specifically, ***
Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid
A water system not protected against backflow. Specifically, ***
Failure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent
contamination before reuse. Specifically, ***
Failure to equip each refrigerator with a thermometer located in the warmest region thereof.
Specifically, ***
Adequate [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees are not readily
accessible adjacent to [places] [areas] where [land] [air] conveyances are [serviced] [maintained]
[cleaned]. Specifically, ***
Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal].
Specifically, ***
Not all [tanks] [piping] bear clear marks of identification. Specifically, ***
Filling connections not [easily cleanable] [located and protected] so as to minimize the hazard of
contamination of the water supply. Specifically, ***
Servicing area are not [provided with all necessary sanitary facilities] [operated] [maintained] as to
prevent the spread of communicable diseases. Specifically, ***
Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas]
[stations]. Specifically, ***
Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures]
[apparatus] [equipment]. Specifically, ***
Adequate facilities are not provided for the [cleaning] [bactericidal treatment] of [multiuse eating and
drinking utensils] [equipment used in the preparation of food and beverages]. Specifically, ***
Signs directing food-handling employees to wash their hands after each use of toilet facilities are not
[posted] [readily observable by such employees]. Specifically, ***
Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold
running water]. Specifically, ***
Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free
from flies, rodents, and other vermin]. Specifically, ***
Water [of satisfactory sanitary quality] [under head of pressure] [adequate in amount and temperature]
is not easily accessible to all rooms in which [food is prepared] [utensils are cleaned]. Specifically, ***
Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling
employees. Specifically, ***
A connection exists between a nonpotable water system on [a vessel] [your vessel] and a potable water
system on [a] [your] pier; there are no provisions to prevent backflow from the vessel to the pier.
Not all food-handling operations are accomplished so as to minimize the possibility of contaminating
[food] [drink] [utensils]. Specifically, ***
Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food]
[beverages] are constructed so as to be [easily cleaned] [self-draining]. Specifically, ***
Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] multiuse
eating and drinking utensils after each use. Specifically, ***
Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] utensils
(other than multiuse utensils) following the day's operation. Specifically, ***
Failure to keep all equipment clean. Specifically, ***
Failure to maintain [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees in a
clean and sanitary condition. Specifically, ***
Containers used to [receive] [store] garbage are not [water-tight] [readily cleanable] [nonabsorbent]
[equipped with close-fitting covers]. Specifically, ***
Garbage cans are not [emptied daily] [thoroughly washed before being returned for use]. Specifically,
***
Frequency
19
10
1
1
1
Radiological Health 5007 21 CFR 1002.13
Radiological Health 5043 21 CFR 1010.3(a)(1)
Radiological Health 5031 21 CFR 1010.2(a)
Radiological Health 5032 21 CFR 1010.2(b)
Radiological Health 5199 21 CFR 1040.10(h)(1)(iii)
Radiological Health 5203 21 CFR 1040.10(h)(2)(i)
Radiological Health 5034 21 CFR 1010.2(c)
Radiological Health 5150 21 CFR 1040.10(f)(3)

Radiological Health 5153 21 CFR 1040.10(f)(5)(ii)
Radiological Health 5165 21 CFR 1040.10(f)(10)
Radiological Health 5171 21 CFR 1040.10(g)(3)
Radiological Health 5180 21 CFR 1040.10(g)(6)(iv)
Radiological Health 5197 21 CFR 1040.10(h)(1)(i)
Radiological Health 5200 21 CFR 1040.10(h)(1)(iv)
Radiological Health 5206 21 CFR 1040.10(i)
Radiological Health 5213 21 CFR 1040.11(c)

Radiological Health 5222 21 CFR 1040.20(d)(1)(i)
Radiological Health 5236 21 CFR 1040.20(e)(1)(i)
Radiological Health 5468 21 CFR 1020.30(j)
Radiological Health 5472 21 CFR 1020.30(k)
Radiological Health 5479 21 CFR 1020.30(n)

Short Description
Failure to submit
ID label lacks name and address
Failure to submit, distinct marking
Quality control procedures
Lack of certification of conformance
Certification label or tag
Legible reproductions
Reproduction of affixed information
Aperture label
Failure to submit
Failure to report
FDA not notified of defect or noncompliance
Certification not based on adequate test/testing

program
ID label lacks place, month & year of manufacture
Remote interlock connector

Emission indicator - Class IIIb & IV
Manual reset not provided
Class IV "Danger" label
NIPH label wording - Class IIIb
User information, adequate instructions
User info - list controls, etc.
Certified product modification
Med. laser compliance, measurement
Demonstration laser products

Label - Warning statement
Reproduction of labels
Mandatory warning on control panel
Compliance measurements--diagnostic source

assembly
Compliance measurement
Results of tests
Methods, devices, procedures for testing
Basis for selecting methods, devices, procedures

Long Description
You did not submit an annual report [by the September 1 deadline] for products requiring one.
Specifically, ***
An identification label failed to provide the name and address of the [manufacturer] [individual or
company under whose name the product was sold]. Specifically, ***
You did not submit a required product report [distinctly marked "Radiation Safety Product Report of
(your name)"] prior to the introduction of the product into commerce. Specifically, ***
You have not [established] [maintained] records containing a description of quality control procedures
with respect to electronic product radiation safety. Specifically, ***
Failure to furnish to the [dealer] [distributor], at the time of delivery of a product, a certification that the
product conforms to all applicable standards. Specifically, ***
A certification label or tag is not [in the English language] [permanently affixed or inscribed] [legible]
[readily accessible to view when the product is fully assembled for use]. Specifically, ***
Legible reproductions of all labels and hazard warnings required by the regulations [were not affixed to
the laser product] [were not provided with the laser product] [did not include the information required
for positions 1, 2, and 3 of the logotype specified in the CFR]. Specifically, ***
The manufacturer did not provide or cause to be provided in all [catalogs] [specification sheets]
[descriptive brochures] pertaining to each laser product, a legible reproduction of [the class designation]
[the warning] [the information required for positions 1, 2, and 3 of the applicable logotype] required b to
be affixed to the product. Specifically, ***
A label bearing the wording: "Laser aperture". is not affixed to the medical laser product, in close
proximity to the aperture through which was emitted accessible laser radiation in excess of the
accessible emission limits of Class I. Specifically, ***
You did not submit a required supplemental report, prior to the introduction of the product into
commerce, for a new or modified model within a model or chassis family. Specifically, ***
You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported
to or otherwise known to you. involving a product introduced or intended to be introduced into
commerce by you. Specifically, ***
You did not notify the Secretary, in accordance with 21 CFR 1003.20, of an electronic product which [was
defective] [failed to comply with an applicable Federal standard] which you [produced] [assembled]
[imported] [distributed]. Specifically, ***
Certification was not based upon [a test, in accordance with the standard] [a testing program in
accordance with good manufacturing practices]. Specifically, ***
An identification label fails to provide the [place] [month] [year] of manufacture. Specifically, ***
Each laser system classified as a Class IIIb or Class IV laser product [was not incorporated with a readily
available remote interlock connector having an electrical potential difference of no greater than 130
root-mean-square volts between terminals.] [had no means to prevent, when the terminals of the
connector are not electrically joined, human access to all laser and collateral radiation from the laser
product in excess of the accessible emission limits of Class I and table VI.] Specifically, ***
An emission indicator [was not incorporated in each laser system classified as a Class IIIb or Class IV laser
product, which provides a visible or audible signal during emission of accessible laser radiation in excess
of the accessible emission limits of Class I] [which signals sufficiently prior to emission of such radiation,
to allow appropriate action to avoid exposure to the laser radiation]. Specifically, ***
Each laser system, manufactured after August 20, 1986 and classified as a Class IV laser product, was not
provided with a manual reset to enable resumption of laser radiation emission after interruption of
emission, caused by the use of a remote interlock or after an interruption of emission in excess of 5
seconds duration due to the unexpected loss of main electrical power. Specifically, ***
Each Class IV laser product does not have affixed a label [bearing the DANGER logotype specified in the
regulation] [bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR
SCATTERED RADIATION" in the position specified in the regulation] [bearing the wording "CLASS IV LASER
PRODUCT" in the position specified in the regulation]. Specifically, ***
Labels regarding Class IIIb accessible laser radiation which [are visible on the protective housing prior to
displacement or removal of such portions of the protective housing] [are visible on the product in close
proximity to the opening created by removal or displacement of such portions of the protective housing]
[include the wording: "DANGER --- Laser radiation when open. AVOID DIRECT EXPOSURE TO BEAM."]
were not provided for noninterlocked protective housings. Specifically, ***
Adequate instructions for each laser product were not provided or caused to be provided for [assembly]
[operation] [maintenance] [clear warnings concerning precautions to avoid possible exposure to laser
and collateral radiation in excess of the accessible emission limits specified in the regulations] [a
maintenance schedule necessary to keep the product in compliance with the standard]. Specifically,
***
The manufacturer did not provide or cause to be provided a listing of [all controls] [all adjustments] [all
procedures for operation and maintenance] [the warning: "Caution --- use of controls or adjustments or
performance of procedures other than those specified herein may result in hazardous radiation
exposure."]. Specifically, ***
A previously certified laser product which has been modified, which modification affects any aspects of
the product's performance or intended function(s), has not been [recertified] [reidentifyied] Specifically,
***
The medical laser product [fails to comply with all of the applicable requirements of Sec. 1040.10 for
laser products of its class.] [does not incorporate in each Class III or IV medical laser product a means for
the measurement of the level of that laser radiation intended for irradiation of the human body, having
an error in measurement of no more than 20% when calibrated in accordance with the CFR
requirements]. Specifically, ***
Each demonstration laser product [does not comply with all of the applicable requirements for a Class I,
IIa, II, or IIIa laser product] [does not prevent human access to laser radiation in excess of the accessible
emission limits of Class I, IIa, II or IIIa]. Specifically, ***
Each sunlamp product does not have a label containing the warning statement: "DANGER --- Ultraviolet
radiation. Follow instructions. Avoid overexposure. As with natural sunlight, overexposure can cause eye
and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and
skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM
INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation.
Consult physician before using sunlamp if you are using medications, or have a history of skin problems
or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan
from the use of this product." Specifically, ***
The users' instructions for the sunlamp product did not contain a reproduction of the required label(s)
prominently displayed at the beginning of the instructions. Specifically, ***
The required warning statement "Warning: This x-ray unit may be dangerous to patient and operator
unless safe exposure factors and operating instructions are observed" [is not present on the control
panel containing the main power switch] [is not legible and accessible to view]. Specifically, ***
Compliance for radiation leakage from the diagnostic source assembly was not determined by
measurements averaged over an area of 100 square centimeters with no linear dimension greater than
20 centimeters. Specifically, ***
Compliance with the aluminum equivalence limits was not determined by x-ray measurements made [at
a potential of 100 kilovolts peak] [with an x-ray beam that has a half-value layer of 2.7 millimeters of
aluminum]. Specifically, ***
You have not [established] [maintained] records of the results of tests for electronic product radiation
safety, including the control of unnecessary, secondary or leakage electronic product radiation.
Specifically, ***
You have not [established] [maintained] records of the [methods] [devices] [procedures] used in tests for
electronic product radiation safety. Specifically, ***
You have not [established] [maintained] records of the basis for selecting the [methods] [devices]
[procedures] used in tests for electronic product radiation safety. Specifically, ***
Frequency
1
1
1
1
1
Veterinary Medicine 4185 FDCA 402(a)(4)
Veterinary Medicine 4093 21 CFR 530.11(d)
Veterinary Medicine 4097 21 CFR 530.20(a)(2)(iv)
Veterinary Medicine 4298 21 CFR 530.11(a)
Veterinary Medicine 21301 21 CFR 507.34(a)(1)
Veterinary Medicine 18206 21 CFR 507.19(e)
Veterinary Medicine 18219 21 CFR 507.25(b)(1)

Veterinary Medicine 4564 21 CFR 225.180
Veterinary Medicine 4541 21 CFR 225.42(b)

Veterinary Medicine 18223 21 CFR 507.25(c)(2)

Veterinary Medicine 4099 21 CFR 530.20(a)(2)(ii)


Veterinary Medicine 4098 21 CFR 530.20(a)(2)(i)
Veterinary Medicine 4100 21 CFR 530.20(a)(2)(iii)
Veterinary Medicine 4111 21 CFR 530.12(c)
Veterinary Medicine 18204 21 CFR 507.19(d)(2)


Veterinary Medicine 21537 21 CFR 514.80(b)(2)(i)
Veterinary Medicine 21551 21 CFR 514.80(b)(4)(iv)(B)

Short Description
Record keeping
Tissue residue
Tissue residue
Rx not followed
Drug inventory
Expired drugs
Drugs prohibited for extralabel use in food producing

animal
Preventive Controls
Identity of animals
Hazard Analysis
System for administration of drugs
Withdrawal period
Records review prior to slaughter
Extra label use w/o veterinary client-patient

relationship
Medication status of animals
Pest Control
Raw Material Controls

Conditions of use
Bagged or bulk deliveries
Plant Operations
Species or class
Three assays per year
Adequate procedures established
Holding and Distribution
Food Safety Plan
Dosage level
Hospital pen
Maintained in clean and orderly condition
Pest access minimized
Elements of production record(s)
Adequate procedures for Type A and Type B articles
Establishment and use of adequate procedures
Grounds
Plant Maintenance
Manufacturing, Processing, Packing, Holding -

Measures
Distribution of feed not in conformance with lawful
VFD
Food Safety Plan
Establishment and Implementation of Corrective Action

Procedures
Validation of Process or Other Preventive Control
Reanalysis of FSP
Capability to produce a medicated feed
Maintenance reasonably clean & orderly
Daily inventory record kept
Reasonable and effective procedures followed
Preparation of MRF
Extended withdrawal period
Withdrawal, withholding, or discard time
Frequency of administration
Scales and metering devices
Investigation and corrective action
Elements of records
Use of veterinary prescription drugs without a

prescription
Record Requirements
Personnel
Sanitation
Water Supply and Plumbing
Identification of Rework
Contamination with Mycotoxins/Natural Toxins
Extralabel use, Incorrect use or labeling
Acknowledgement letter
Process Controls
Recall Plan
Documentation of Verification Activities
Calibration
Environmental Monitoring
Evaluation and supervision of employees
Route of administration
Feeding areas
Feeding colostrum
Space and lighting for operations
Suitable for intended purpose
Calibration of scales and metering devices
Designed for inspection and use of cleanout
Elements of receipt record
Discrepancies
Assay results out of specification

Distribution discontinued
Sequential production
Maintaining proofread label
Elements of the MRF
Daily review of production records
Discrepancies investigated, reported
Diagnosis and evaluation of conditions
Identity of treated animals
Directions for use
Properly installed
Vermin and pest infestation
Cleanliness, inspection, cleanout
Individual/Employee Qualifications
Plant Construction and Design
Toxic Substances
Equipment and Utensils - avoid adulteration
Animal Food Contact Surfaces
Work-in-Process and Rework
No VFD
After expiration
Filling incomplete VFD
Establishment and Implementation of Monitoring

Preventive Controls
Monitoring Records for Preventive Controls
Documentation of Corrective Actions
Validation Requirements for Preventive Controls
Record Review
Qualifications For Preventive Controls Qualified

Individual
Supply-Chain Written Procedures for Receiving Raw
Materials
Applicant did not establish/maintain/keep complete

safety/effectiveness records
Did not submit or late submission of 15-Day Initial alert

report
Timely submission of Periodic drug experience report
Periodic report did not note adverse drug experiences

in literature
Long Description
Treatment records were not [maintained] [complete]. Specifically,***

Causing a residue of an approved human or animal drug above an established safe level, safe
concentration, or tolerance, through use of the drug contrary to its labeling. Specifically, ***
Causing an illegal residue in a food-producing animal of an approved human or animal drug through
[prescribing the use of] [using] the drug contrary to its labeling, and failing to take appropriate measures
to assure that [assigned timeframes for withdrawal were met] [no illegal residue would occur].
Specifically, ***
Failure to follow your veterinarian's prescription for [dosage] [frequency and duration of treatment]
[route of administration] [species or class of animal] [pre-slaughter withdrawal time] [special cautionary
directions]. Specifically, ***
You lack an adequate inventory system for determining the quantities of drugs used to medicate your
[cows] [calves] [livestock]. Specifically, ***
Expired drug(s) were observed in the drug storage area. Specifically, ***
A prohibited [drug] [substance] was administered in an extralabel manner to [a] food-producing

animal(s). Specifically, ***_x000D_
_x000D_
_x000D_
You did not identify and implement preventive controls to ensure that any hazards requiring a preventive
control are significantly minimized or prevented. Specifically, ***
Failure to [identify] [maintain records regarding the identity of] [record the existing identification of] the
animal(s) that you [purchased] [transported] and delivered for [sale] [consignment] at [an auction yard]
[a slaughter plant]. Specifically, ***
You did not [have a written hazard analysis] [evaluate each known or reasonably foreseeable hazard]
[include an evaluation of environmental pathogens] for each type of animal food you manufacture,
process, pack or hold in your facility. Specifically, ***
Failure to have a system to control administration of drug treatments to your animals. Specifically, ***
Administration of an approved animal drug contrary to the labeling, without benefit of a valid
veterinarian-client-patient relationship, in that pre-slaughter withdrawal time was not observed.
Specifically, ***
Failure to systematically review treatment records prior to offering an animal for slaughter for human
food, to assure that drugs have been used only as directed and that appropriate withdrawal times have
been observed. Specifically, ***
Use of [a human] [an animal] drug in a manner contrary to label directions without benefit of a valid
veterinary client-patient relationship. Specifically, ***
Failure to inquire about the medication status of the animal(s) that you [transported] [purchased] and
delivered for [sale] [consignment] at [an auction yard] [a slaughter plant]. Specifically, ***
You did not take effective measures to [exclude pests from your plant] [protect against contamination of
animal food by pests]. Specifically, ***
You did not inspect, segregate, or otherwise handle [shipping containers] [raw materials] [ingredients]
used in manufacturing [to ensure they were clean and suitable for processing] [under conditions that will
protect the animal food against contamination and minimize deterioration]. Specifically, ***
Administration of a drug for conditions not [specified in its labeling] [prescribed]. Specifically, ***
All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that
the feed can be properly used. Specifically, ***
You did not [conduct operations in accordance with current good manufacturing practices] [ensure the
safety and suitability of the food-packaging materials] [assign supervision of overall plant cleanliness]
[take adequate precautions to prevent contamination of animal food] [use testing procedures to identify
sanitation failures] [reject, treat or process to eliminate contaminated food] [conduct all animal food
manufacturing under such conditions and controls to protect against contamination of animal food].
Specifically, ***
Administration of an approved human or animal drug to a [species of animal] [class of animal] for which
the drug was not labeled, without benefit of a valid veterinarian-client-patient relationship. Specifically,
***
Periodic assays are not performed during the calendar year on at least three representative samples of
medicated feeds requiring a medicated feed mill license, for each drug or drug combination used.
Specifically, ***
Adequate procedures are not established for the [receipt] [storage] [inventory control] of all drugs to aid
in assuring their identity, strength, quality and purity when incorporated into products. Specifically, ***
You did not hold animal food for distribution under conditions that protect against contamination and
minimize deterioration. Specifically, ***
You did not have a written food safety plan. Specifically, ***
Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid
veterinarian-client-patient relationship. Specifically, ***
Failure to [identify] [segregate] [quarantine] treated animals. Specifically, ***
Buildings are not maintained in a reasonably clean and orderly manner. Specifically, ***
The building is not constructed to minimize access by [rodents] [birds] [insects] [pests]. Specifically, ***
Production record(s) fail to include [the product identification] [the date of production] [a written
endorsement in the form of a signature or initials by a responsible individual] [the quantity and name of
drug components used] [the theoretical quantity of medicated feed to be produced] [the actual quantity
of the medicated feed produced] [an estimate of the quantity to be produced and stored in bulk, based
on the basis for the estimate in the Master Record File (MFR)]. Specifically, ***
Adequate procedures are not [established] [maintained] for the [identification] [storage] [inventory
control (receipt and use)] of all Type A medicated articles and Type B medicated feeds intended for use in
the manufacture of medicated feeds. Specifically, ***
Adequate procedures are not [established] [used] for all equipment used in the production and
distribution of medicated feeds to avoid unsafe contamination of medicated [and nonmedicated] feeds.
Specifically, ***
You did not keep the grounds around your animal food plant in a condition that would protect against
the contamination of animal food. Specifically, ***
You did not maintain your plant [in a clean manner] [in good repair] to prevent animal food from
You did not take adequate measures to significantly minimize or prevent the growth of undesirable
microorganisms in your animal food. Specifically, ***
You distributed an animal feed containing a VFD drug or combination VFD drug [without a complete VFD]
[that did not conform with the VFD]. Specifically, ***
A preventive controls qualified individual did not prepare or oversee the preparation of your food safety
plan. Specifically, ***
You did not [establish] [implement] appropriate written corrective action procedures for preventive
controls. Specifically, ***
You did not validate your identified [process preventive control] [other preventive control] to adequately
control the hazard as appropriate to the nature of the preventive control and its role in your food safety
system. Specifically, ***
You did not conduct a reanalysis of your food safety plan as appropriate. Specifically, ***
Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety]
[purity]. Specifically, ***
Equipment is not maintained in a reasonably clean and orderly manner. Specifically, ***
Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds.
Specifically, ***
All equipment that comes in contact with [active drug components] [feeds in process] [finished
medicated feed] is not subject to all reasonable and effective procedures to prevent unsafe
contamination of manufactured feed. Specifically, ***
A Master Record File providing the complete procedure for manufacturing a specific product is not
[prepared] [checked] [dated] [signed or initialed] by a qualified person. Specifically, ***_x000D_
A substantially extended withdrawal period, supported by appropriate scientific information, was not
established for the use of an approved drug in a food-producing animal, in an extralabel manner.
Specifically, ***
Failure to provide labeling containing [withdrawal] [withholding] [discard] time as specified by the
veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.
Specifically, ***
Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling]
[prescribed]. Specifically, ***
The [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision]
[accuracy] for their intended purpose. Specifically, ***
Results of laboratory assays of drug components indicated that medicated feed was not in accord with
the permissible limits, and no [investigation] [corrective action] was implemented immediately.
Specifically, ***
Formula, production and distribution records are not maintained identifying the [formulation] [date of
mixing] [date of shipment (if not for own use)]. Specifically, ***
Administration of veterinary prescription drugs was performed without the lawful written or oral order
of a licensed veterinarian. Specifically, ***
You did not establish records documenting the training of principles of animal food hygiene and animal
food safety for individuals engaged in the manufacturing, processing, packing or holding of animal food.
Specifically, ***
You did not take reasonable measures and precautions related to hygienic practices to protect against
the contamination of animal food. Specifically, ***
You did not [clean] [maintain] [store] utensils and equipment in a manner that protects against
Your plant does not have adequate [water] [plumbing] [sewerage system ] [toilet facilities] [hand-
washing facilities] to protect against a potential source of contamination to animal food. Specifically, ***
You did not accurately identify [raw materials] [other ingredients] [rework]. Specifically, ***
You did not [evaluate] [use] the [raw materials] [ingredients] susceptible to contamination with
mycotoxins or other natural toxins in a manner that does not result in animal food that can cause injury
or illness to animals or humans. Specifically, ***
You did not [manufacture] [label] [use] the VFD [drug] [combination drug] [feed] in accordance with the
approved, conditionally approved, or indexed conditions of use and/or labeling. Specifically, ***
You distributed VFD feed to another distributor without first obtaining a written (nonverbal)
acknowledgement letter from the receiving distributor (consignee) before the feed was shipped.
Specifically, ***
Your process controls did not include procedures, practices, and/or processes that ensure the control of
parameters during operations to significantly minimize or prevent hazards. Specifically, ***
Your written recall plan did not include [the steps to be taken] [assigned responsibilities] for conducting
recalls. Specifically, ***
You did not document verification activities. Specifically, ***
You did not verify that your preventive control(s) are consistently implemented and effective by
performing calibration of process monitoring and verification instruments. Specifically, ***
You did not verify that your preventive control(s) are consistently implemented and effective through
environmental monitoring. Specifically, ***
Failure to provide an on-going program of evaluation and supervision of employees in the manufacture
of medicated feeds. Specifically, ***
Administration of an approved animal drug via a route, [oral] [intramuscular] [intravenous]
[subcutaneous] [topical] [intramammary] [intrauterine], which was not indicated in the labeling, without
benefit of a valid veterinarian-client-patient relationship. Specifically, ***
Failure to adequately clean feed and water containers to prevent cross-contamination of medicated and
non-medicated feeds and liquids. Specifically, ***
Feeding colostrum or milk from treated cows to calves intended for slaughter. Specifically, ***
Buildings do not provide adequate [space] [lighting] for [receipt, control, and storage of components]
[component processing] [medicated feed manufacturing] [packaging and labeling] [storage of containers
and packaging materials] [storage of labeling] [storage of finished products] [routine maintenance of
equipment]. Specifically, ***
Equipment is not of suitable [size] [design] [construction] [precision] [accuracy] for its intended purpose.
Specifically, ***
Failure to calibrate scales and metering devices [upon installation] [at least once a year after installation]
[as frequently as necessary] to insure their accuracy. Specifically, ***
Equipment is not [designed] [constructed] [installed] [maintained] so as to facilitate inspection and use
of cleanout procedures. Specifically, ***
Drug receipt records do not accurately indicate the [identity] [quantity] [name of the supplier] [supplier's
lot number or other identifying number] [date of receipt] [condition of the drug when received] [return
of any damaged drugs] for each lot of drug received. Specifically, ***
Failure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage
and theoretical drug usage. Specifically, ***
Failure to [investigate] [implement corrective action] [maintain a record on the premises of corrective
action] when assay results show medicated feeds [not in accord with label specifications] [not within
permissible assay limits]. Specifically,***
Distribution of a medicated feed which failed to meet its labeled drug potency was not discontinued.
Specifically, ***
Sequential production of medicated feeds is not done on a predetermined basis designed to prevent
unsafe contamination of feeds with residual drugs. Specifically, ***
Proofread labels are not [initialed and dated by a responsible individual] [kept for one year after all the
labels from that batch have been used]. Specifically, ***
The Master Record File does not contain [the name of the medicated feed] [the name and weight
percentage or measure of each drug or drug combination and each nondrug ingredient to be used in
manufacturing a stated weight of medicated feed] [a copy or description of the label that will accompany
the medicated feed] [manufacturing instructions or reference thereto that have been determined to
yield a properly mixed medicated feed of the specified formula for each medicated feed produced]
[appropriate control directions including the collection of samples for specified laboratory assays] [the
basis for estimating quantity produced, where actual yield cannot be accurately determined when
finished feed is stored in bulk]. Specifically, ***
The batch production records are not checked by a responsible individual at the end of the working day
to determine whether all required production steps have been performed. Specifically, ***_x000D_
When significant discrepancies were noted on the batch production records, there was a failure to
[institute an investigation immediately] [describe the corrective action taken on the production record].
Specifically, *** _x000D_
_x000D_
Failure to make a careful diagnosis and evaluation of the conditions for which an approved human or
animal drug was to be used in a food-producing animal, contrary to the drug's labeling. Specifically, ***
Failure to assure that the identity of a food-producing animal was maintained, where you had prescribed
or dispensed an approved human or animal drug contrary to the drug's labeling. Specifically, ***
Failure to provide labeling containing directions for use as specified by the veterinarian for a human or
animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
Equipment is not properly installed so as to [permit production of feeds of uniform quality] [facilitate
cleaning] [minimize spillage of drug components and finished product]. Specifically, ***
Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest
infestation. Specifically, ***
Equipment for producing medicated feeds of intended potency and purity is not [maintained in a
reasonably clean and orderly manner] [designed, constructed, installed and maintained so as to facilitate
inspection and use of cleanout procedures]. Specifically, ***
You did not ensure that all individuals who manufacture, process, pack, or hold animal food are qualified
to perform their assigned duties. Specifically, ***
Your plant is not constructed or designed to facilitate cleaning, maintenance and pest control to reduce
the potential for contamination. Specifically, ***
You did not [identify] [use] [store] toxic chemicals in a manner that protects against contamination.
Specifically, ***
Your equipment and utensils are not [designed] [constructed] [used] appropriately to avoid the
adulteration of animal food with contaminants. Specifically, ***
Animal food contact surfaces are not [made of appropriate materials] [maintained] to protect animal
food from being contaminated. Specifically, ***
You did not handle work-in-process and rework in a manner that protects against contamination.
Specifically, ***
You fed an animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or
combination VFD feed) without a lawful VFD issued by a licensed veterinarian. Specifically, ***
You fed a VFD feed or combination VFD feed to animals after the expiration date on the VFD. Specifically,
***
You filled a VFD that does not contain all the information required in this regulation. Specifically, ***
You did not [establish written procedures for] [implement] monitoring, including adequate frequency for
your preventive controls. Specifically, ***
Preventive control monitoring records are not [maintained] [complete]. Specifically, ***
You did not document corrective action. Specifically, ***
Your preventive control validation was not [performed (or overseen) by a preventive controls qualified
individual] [performed when necessary] [based on scientific evidence]. Specifically, ***
Your records were not reviewed [within specified timeframes] by (or under the oversight of) a preventive
controls qualified individual. Specifically, ***
Your preventive controls qualified individual was not qualified through training or experience.
Specifically, ***
You did not [establish] [implement] [document the use of] written procedures for receiving raw materials
and other ingredients. Specifically, ***
Applicant did not establish or maintain an indexed and complete file of records with all pertinent
domestic and foreign information related to safety and effectiveness of a new animal drug received or
otherwise obtained by Applicant. Specifically, ***
Applicant did not submit a 15-Day NADA/ANADA alert report(s) of adverse drug events that are both
serious and unexpected [within 15 working days of receipt of information] to FDA. Specifically, ***
Periodic drug experience report was not submitted by the Applicant [within 30 days following the end of
the 6 month reporting period for the first 2 years after approval of NADA/ANADA] [within 90 days of the
anniversary date of the approval of the NADA or ANADA starting 2 years after approval of
NADA/ANADA]. Specifically, ***
Applicant did not [note adverse events found in literature] [include a bibliography of pertinent
references] in the periodic drug experience report. Specifically, ***
Frequency
113
89
29
18
18
17
15
15
11
11
10
7
5
3
3
3
3
2
2
1
1
1
1
1
1

Inspection Observations FY19 0

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Number of 483 issued from the Sy

Inspections ending between 10/1/2018 an

*This table does not represent the complete

** This is the Actual Total number of 483's issu

Inspections ending between 10/1/2018 and 9/30/2019

Cite Program Area Name 483s Issued

Bioresearch Monitoring 190

Human Tissue for Transplantation 109

Parts 1240 and 1250 47

Veterinary Medicine 229

Sum Product Area 483s from System* 4849

Actual Total in System 483s** 4770

Biologics 76 21 CFR 606.100(b)

Biologics 9225 21 CFR 606.171

Biologics 154 21 CFR 606.160(a)(1)

Biologics 155 21 CFR 606.160(b)

Biologics 18093 21 CFR 630.10(g)(1)

Biologics 98 21 CFR 606.100(c)

Biologics 57 21 CFR 606.60(a)

Biologics 4425 21 CFR 606.60(a)

Biologics 150 21 CFR 606.151(e)

Biologics 160 21 CFR 606.160(a)(1)

Biologics 12203 21 CFR 606.170(a)

Biologics 15030 21 CFR 606.60(b)

Biologics 18038 21 CFR 606.100(b)

Biologics 31 21 CFR 606.20(b)

Biologics 41 21 CFR 606.40(a)(1)

Biologics 78 21 CFR 606.100(c)

Biologics 18074 21 CFR 630.10(c)

Biologics 18082 21 CFR 630.10(e)(2)

Biologics 35 21 CFR 606.40

Biologics 158 21 CFR 606.160(e)(1)

Biologics 9086 21 CFR 600.14(a)(1)

Biologics 9089 21 CFR 600.14(c)

Biologics 9241 21 CFR 630.40(a)

Biologics 9262 21 CFR 610.40(b)

Biologics 9449 21 CFR 610.18(b)

Biologics 18089 21 CFR 630.10(f)(4)

Biologics 18092 21 CFR 630.10(f)(6)(ii)

Biologics 18118 21 CFR 630.30(b)(1)

Biologics 67 21 CFR 606.65(e)

Biologics 80 21 CFR 606.100(b)(1)

Biologics 93 21 CFR 606.100(b)(14)

Biologics 94 21 CFR 606.100(b)(15)

Biologics 161 21 CFR 606.160(a)(2)

Biologics 181 21 CFR 610.53(b)

Biologics 224 21 CFR 640.4(f)

Biologics 227 21 CFR 640.4(h)

Biologics 238 21 CFR 640.11(a)

Biologics 251 21 CFR 640.25(b)

Biologics 274 21 CFR 640.34(c)

Biologics 333 21 CFR 640.64(e)

Biologics 334 21 CFR 640.64(e)

Biologics 355 21 CFR 640.69(b)

Biologics 9044 21 CFR 600.10(b)

Biologics 9052 21 CFR 600.11(b)

Biologics 9076 21 CFR 600.12(a)

Biologics 9078 21 CFR 600.12(a)

Biologics 9097 21 CFR 600.15