Inspections, Compliance, Enforcement, and Criminal Investigations

FY 2017 Inspectional Observation Summaries

Number of 483s Issued from the System*

Inspections ending between 10/1/2016 and 9/30/2017

 
Center Name 483s Issued
Biologics 115
Bioresearch Monitoring 243
Devices 1030
Drugs 694
Foods 2662
Human Tissue for Transplantation 61
Parts 1240 and 1250 75
Radiological Health 31
Veterinary Medicine 244
Sum Product Area 483s from System* 5155
Actual Total in System 483s** 5045
 
 

*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.

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Cite Id Reference Number Short Description Long Description Frequency
76 21 CFR 606.100(b) Establish, maintain and follow manufacturing SOPs 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, *** 49
98 21 CFR 606.100(c) Thorough investigations 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,***



20
155 21 CFR 606.160(b) Required records Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records.  Specifically, *** 20
154 21 CFR 606.160(a)(1) Concurrent documentation 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, *** 17
4425 21 CFR 606.60(a) Equipment observed, standardized, calibrated 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, *** 8
15030 21 CFR 606.60(b) Equipment calibration frequency 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, *** 7
67 21 CFR 606.65(e) Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.  Specifically, *** 6
78 21 CFR 606.100(c) Record review prior to release 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, *** 6
160 21 CFR 606.160(a)(1) Person performing, test results, interpretation 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, *** 6
9225 21 CFR 606.171 Biological product deviation report Failure to submit a biological product deviation report [within 45 days from the date you acquired information suggesting that a reportable event occurred].  Specifically, *** 6
18038 21 CFR 606.100(b) SOPs for investigations, records 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, *** 6
18093 21 CFR 630.10(g)(1) Proof Of Identity 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, *** 6
150 21 CFR 606.151(e) Procedures to maintain records of emergency transfusions Records [including signature by the physician requesting the procedure] are not maintained of all emergency transfusions [including complete documentation justifying the emergency action].  Specifically, *** 5
18082 21 CFR 630.10(e)(2) Additional Medical Assessment Factors 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, *** 5
94 21 CFR 606.100(b)(15) Schedules and procedures for equipment & calibration The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration.  Specifically, *** 4
41 21 CFR 606.40(a)(1) Provide space for examination Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their eligibility as blood donors.  Specifically, ***

3
57 21 CFR 606.60(a) Maintain and clean equipment 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, *** 3
9089 21 CFR 600.14(c) When to report Biological product deviations [were] [are] not reported within the 45 calendar day timeframe.  Specifically, ***  3
18077 21 CFR 630.10(d)(2) Donation interval Failure to determine the eligibility of a donor by assuring the interval since the donor's last donation was appropriate before collection.  Specifically, *** 3
18096 21 CFR 630.10(g)(2)(ii) Donor's Acknowledgment - Exculpatory language 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, *** 3
31 21 CFR 606.20(b) Qualifications of responsible personnel 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, *** 2
35 21 CFR 606.40 Clean & orderly Failure to maintain facilities in a clean and orderly manner.  Specifically, *** 2
36 21 CFR 606.40 Suitable size, construction, etc. Failure to provide facilities of  suitable [size] [construction] [location] so as to facilitate adequate cleaning, maintenance and proper operations.  Specifically, *** 2
50 21 CFR 606.40(c) Provide adequate handwashing Failure to provide [adequate] [clean] [convenient] handwashing facilities for personnel.  Specifically, *** 2
61 21 CFR 606.60(a) Provide proper equipment to meet requirements Failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in 21 CFR 606.  Specifically, *** 2
89 21 CFR 606.100(b)(10) Controlling storage temperatures The standard operating procedure fails to include a written description of the storage temperatures and methods of controlling storage temperatures for all blood products and reagents  Specifically, *** 2
113 21 CFR 606.121(b) Collection/initial processing facility labels Container label(s) provided by the [collection facility] [initial processing facility] were [removed] [altered] [obscured] and the modifications to the label did not reflect the proper name of the product, with any appropriate modifiers and attributes, and other information required to accurately identify the contents. Specifically, *** 2
12202 21 CFR 606.170(a) Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made.  Specifically, 2
12203 21 CFR 606.170(a) Adverse Reaction- Reports of Investigations Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained.  Specifically,  2
15041 21 CFR 610.47(b) Lookback System [Consignee] Failure to [establish] [maintain] [follow] an appropriate system for HCV lookback.  Specifically, *** 2
15046 21 CFR 610.47(b)(3) Timeframe for Notification of Transfusion Recips [Consignee] Failure to make reasonable attempts to perform notification within 12 weeks after receiving the further testing results for evidence of HCV infection from the collecting establishment or after receiving the donor's reactive screening test result for HCV.  Specifically, *** 2
18068 21 CFR 630.5(d) CPR certification 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, *** 2
18097 21 CFR 630.10(h) Ineligible Donor 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, *** 2
18119 21 CFR 630.30(b)(2) Unsuitable donation - defer testing 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, *** 2
18134 21 CFR 640.21(g) Informed consent 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, *** 2
38 21 CFR 606.40(b) Adequate lighting, ventilation, and screening Failure to provide adequate [lighting] [ventilation] [screening of open windows and doors].   Specifically, *** 1
53 21 CFR 606.40(d)(1) Provide adequate disposal of trash & discarded items Failure to provide for safe and sanitary disposal for trash and items used during the [collection] [processing] [compatibility testing] of blood and blood components.  Specifically, *** 1
63 21 CFR 606.65 Safe, sanitary, orderly storage Failure to store all supplies and reagents used in the [collection]  [processing] [compatibility testing] [storage] [distribution] of blood and blood components in a safe, sanitary and orderly manner.  Specifically, *** 1
77 21 CFR 606.100(b) Written SOPs available for use by personnel Failure to make available written procedures for use by personnel in the areas where the procedures are performed.  Specifically, *** 1
87 21 CFR 606.100(b)(8) Methods for pre-transfusion testing The standard operating procedure fails to include a written description of pretransfusion testing, where pretransfusion testing is applicable, including precautions to be taken to identify accurately the recipient blood samples and crossmatched donor units.  Specifically, *** 1
88 21 CFR 606.100(b)(9) Written methods for investigating adverse reactions The standard operating procedure fails to include a written description of the procedures for investigating adverse donor and recipient reactions.  Specifically, *** 1
137 21 CFR 606.121(c)(13) Unapproved encoded/machine readable information The container label of blood and blood components intended for transfusion bears encoded information in the form of machine-readable symbols which have not been approved for use by the Director, Center for Biologics Evaluation and Research.  Specifically, *** 1
143 21 CFR 606.140(b) Provisions to monitor lab test procedures & instruments Failure to establish  adequate provisions for monitoring the [reliability] [accuracy] [precision] [performance] of laboratory test procedures and instruments.  Specifically, *** 1
159 21 CFR 606.160(a)(1) Legibility and indelibility Records are [illegible] [not indelible].  Specifically, *** 1
161 21 CFR 606.160(a)(2) Determination of lot numbers and supplies Appropriate records are not available to determine the lot numbers of [supplies] [reagents] used for specific [lots] [units] of the final product.  Specifically, *** 1
224 21 CFR 640.4(f) Arm preparation The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.  Specifically, *** 1
246 21 CFR 640.25(a) Storage temps./agitation Failure to store platelets immediately after resuspension [at 20 to 24 degrees Celsius with continuous gentle agitation] [at 1 to 6 degrees Celsius].  Specifically, *** 1
255 21 CFR 640.31 Donor eligibility Failure to ensure that [whole blood] [plasmapheresis] donors met eligibility criteria.  Specifically, *** 1
272 21 CFR 640.34(b) Fresh Frozen Plasma - storage requirements Failure to place plasma, separated from red blood cells and intended to be labeled Fresh Frozen Plasma, in a freezer within eight hours after phlebotomy at a temperature of -18 degrees Celsius or colder.  Specifically, *** 1
337 21 CFR 640.65(b)(1)(iii) Greater than six months since four month sample Failure to process as a new donor, a repeat donor from whom a four month sample had not been obtained in a period exceeding six months.  Specifically, *** 1
9004 21 CFR 606.100(b)(19) Quarantine of blood etc. The written procedures for [HIV] [HCV] "lookback" fail to describe [procedures to notify consignees regarding the need to quarantine] [quarantine of in-date] blood and blood components intended for use in another person or for further manufacture into injectable products, from a donor of blood who has subsequently tested reactive for evidence of [HIV] [HCV] infection, or when you are made aware of other reliable test results or information indicating evidence of infection.  Specifically, *** 1
9006 21 CFR 606.100(b)(19) Notification of attending physicians The written procedures for [HIV] [HCV] "lookback" fail to include procedures to notify [the transfusion recipient] [the transfusion recipient's physician of record] [the transfusion recipient's legal representative] that the transfusion recipient may have received blood and blood components at increased risk for transmitting [HIV] [HCV].  Specifically, *** 1
9044 21 CFR 600.10(b) Personnel capabilities 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, *** 1
9079 21 CFR 600.12(b)(1) Retention - General Records are not retained as required.  Specifically, *** 1
9093 21 CFR 600.80(b) Review of Adverse Experiences - SOPs There are no written procedures for the [surveillance] [receipt] [evaluation] [reporting] of post-marketing adverse experiences to FDA.  Specifically, *** 1
9095 21 CFR 600.80(c)(1)(i) Reporting Requirements - 15-day alert All [serious] [unexpected] adverse experiences were not reported within 15 calendar day of initial receipt of the information.  Specifically, *** 1
9097 21 CFR 600.15 Blood & Blood Components 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, *** 1
9243 21 CFR 630.40(a) Notification 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, *** 1
15045 21 CFR 610.47(b)(3) Notify MD, Legal Rep, Relative of Trans Recipient[Consignee] Failure to notify [physician of record] [legal representative] [relative] of a recipient, 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, *** 1
15077 21 CFR 610.46(b)(3) Timeframe for Notification of Transfusion Recips [Consignee] Failure to make reasonable attempts to perform notification within 12 weeks after receiving the results of further testing for evidence of HIV infection from the collecting establishment or after receiving the donor's reactive screening test result for HIV.  Specifically, *** 1
18041 21 CFR 606.160(e)(2) Cumulative deferral record HTLV, Chagas Failure to maintain at all locations operating under the same license or under common management a cumulative record of donors deferred from donation under the regulations based on reactive testing for evidence of infection due to HTLV or Chagas disease.  Specifically, *** 1
18044 21 CFR 610.40(a)(2) Test for HTLV, syphilis, West Nile, Chagas Failure to test each donation of blood and blood components intended for transfusion or for use in manufacturing a product for evidence of infection with [HTLV] [syphilis]  [West Nile virus] [Chagas disease].  Specifically, *** 1
18092 21 CFR 630.10(f)(6)(ii) Physical Assessment Determination - Skin Examination 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, *** 1
18116 21 CFR 630.30(a)(3) Donor medical history 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, *** 1
18118 21 CFR 630.30(b)(1) Unsuitable donation - release Failure to prevent the release of unsuitable blood and blood components for [transfusion] [further manufacturing].  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
7560 21 CFR 312.60 FD-1572, protocol compliance An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan].  Specifically, *** 140
7530 21 CFR 312.62(b) Case history records- inadequate or inadequate Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent].   Specifically, ***

76
7526 21 CFR 312.62(a) Accountability records Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects].  Specifically, ***

18
7227 21 CFR 50.27(a) Consent form not approved/signed/dated 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, *** 16
7552 21 CFR 312.66 Changes in research Not all changes in research activity were approved by an Institutional Review Board prior to implementation.  Specifically, *** 12
7482 21 CFR 312.50 General responsibilities of sponsors 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, *** 11
7562 21 CFR 312.60 Informed consent 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, *** 10
7318 21 CFR 56.115(a)(2) Minutes of IRB meetings 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, *** 9
7334 21 CFR 56.115(a)(5) List of members 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, *** 9
7388 21 CFR 50.25(a)(2) Reasonably foreseeable risks or discomforts  The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject.  Specifically, *** 9
7281 21 CFR 56.108(a)(1) Initial and continuing reviews The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, *** 8
7290 21 CFR 56.108(c) Members present for review 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, *** 8
7517 21 CFR 312.66 Initial and continuing review 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, *** 7
7520 21 CFR 312.64(b) Safety reports 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, *** 7
7498 21 CFR 312.66 Unanticipated problems Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.  Specifically, ***



6
7531 21 CFR 312.62(c) Record retention 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, ***

6
4007 21 CFR 58.130(a) Conduct: in accordance with protocol Not all nonclinical laboratory studies were conducted in

accordance with the protocol.  Specifically, ***

5
7278 21 CFR 56.107(e) Conflict of interest The IRB allowed a member to participate in the IRB's [initial] [continuing review] of a project in which the member had a conflicting interest.  Specifically, *** 5
7342 21 CFR 56.108(b)(2) Prompt reporting of noncompliance 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, *** 4
7390 21 CFR 50.25(a)(4) Alternate procedures, courses of treatment There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject.  Specifically, *** 4
7456 21 CFR 312.57(d) Bioequivalence samples 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, *** 4
7480 21 CFR 312.50 Ensuring compliance with plan and protocol Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.  Specifically, *** 4
3931 21 CFR 58.35(b)(5) QAU: authorize deviations from protocols or SOPs 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, *** 3
4026 21 CFR 58.185(a)(10) Final report: names of those involved 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, *** 3
7231 21 CFR 50.20 Consent not obtained, exceptions do not apply 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, *** 3
7276 21 CFR 56.107(c) One scientific and one non-scientific member 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, *** 3
7316 21 CFR 56.115(a)(4) Copies of IRB/CI correspondence Copies have not been maintained of all correspondence between the IRB and the investigators.  Specifically, *** 3
7389 21 CFR 50.25(a)(3) Benefits to the subject A description of any benefits [to the subject] [to others] which might reasonably be expected from the research was not included in the informed consent document.  Specifically, *** 3
3902 21 CFR 58.29(a) Personnel: education, training, experience 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, *** 2
3912 21 CFR 58.31(d) Management: testing of test and control articles Testing facility management failed to assure that all test and control articles or mixtures had been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.  Specifically, *** 2
3919 21 CFR 58.33(b) Study director: all data recorded and verified 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, *** 2
3920 21 CFR 58.33(c) Study director: unforeseen circumstances 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, *** 2
3923 21 CFR 58.33(f) Study director: transfer of data to archives 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, *** 2
3932 21 CFR 58.35(b)(6) QAU: review final study report 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, *** 2
4006 21 CFR 58.120(b) Protocol: approval of changes 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, *** 2
7209 21 CFR 50.25(a)(1) Procedures, identification of those which were experimental The informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were experimental].  Specifically, *** 2
7297 21 CFR 56.109(b) Information given to subjects The IRB does not require that information given to subjects as part of informed consent contain all necessary elements of informed consent.  Specifically, ***: 2
7320 21 CFR 56.109(e) IRB approvals/disapprovals - general 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, *** 2
7333 21 CFR 56.104(c) Emergency use and IRB approval A clinical investigator did not report to the IRB [, within five days of use,] the emergency use of a test article for which the IRB had not reviewed the research proposal.  Specifically, *** 2
7335 21 CFR 56.115(a)(6) Written procedures per 56.108(a) and (b) Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).  Specifically, *** 2
7370 21 CFR 56.111(c) Children as subjects The IRB approved the conduct of research involving children as subjects, but did not determine that the research was in compliance with 21 CFR 50 Subpart D.  Specifically, *** 2
7371 21 CFR 56.108(a)(1) Reporting findings and actions to investigator/institution The IRB [has no] [did not follow its] written procedure for reporting its [findings] [actions] to the [investigator] [institution].  Specifically, *** 2
7387 21 CFR 50.25(a)(1) Statement of research, purpose, duration of participation 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, ***



2
7391 21 CFR 50.25(a)(5) Confidentiality, FDA inspection of records 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, *** 2
7411 21 CFR 312.53(c)(1) Investigator statement (FDA 1572) Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation.  Specifically, *** 2
7518 21 CFR 312.64(d) Financial info Information necessary for submission of required financial [certification] [disclosure] statements to FDA was not provided to the sponsor.  Specifically, ***

2
7527 21 CFR 312.62(a) Unused drug disposition (investigator) Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions].  Specifically, *** 

2
7654 21 CFR 56.110(b) Research not eligible for expedited review 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, ***   2
7695 21 CFR 50.25(c) ClincialTrials.gov statement The informed consent document does not include the [complete] required statement:  "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this Web site at any time."  Specifically, *** 2
3903 21 CFR 58.29(b) Personnel: summary of training, job description 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, *** 1
3910 21 CFR 58.31(b) Management: replacing the study director Testing facility management failed to promptly replace the study director as necessary during the conduct of a study.  Specifically, *** 1
3914 21 CFR 58.31(f) Management: personnel understand their functions Testing facility management failed to assure that all personnel clearly understood the functions they were to perform.  Specifically, *** 1
3918 21 CFR 58.33(a) Study director: follow study protocol The study director failed to assure that the protocol, including any change, was approved and was followed.  Specifically, *** 1
3921 21 CFR 58.33(d) Study director: test system specified in protocol The study director failed to assure that test systems were as specified in the protocol.   Specifically, *** 1
3924 21 CFR 58.35(a) QAU: monitor facilities, etc. 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, *** 1
3925 21 CFR 58.35(a) QAU: separate and independent The quality assurance unit, for any given study, was not entirely separate from and independent of the personnel engaged in the direction and conduct of that study.  Specifically, *** 1
3926 21 CFR 58.35(b)(1) QAU: maintain a master schedule 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, *** 1
3928 21 CFR 58.35(b)(3) QAU: inspect study at adequate intervals 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, *** 1
3933 21 CFR 58.35(b)(7) QAU: signed statement in final report The quality assurance unit failed to prepare and sign a statement to be included with the final study report which specified the dates inspections were made and findings reported to management and to the study director.  Specifically, *** 1
3951 21 CFR 58.51 Facility: archives Space is not provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies.  Specifically, *** 1
3956 21 CFR 58.63(c) Equipment: maintenance records Adequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations.  Specifically, *** 1
3958 21 CFR 58.81(a) SOPs: authorization and documentation of deviations Not all deviations from standard operating procedures in a study were authorized by the study director and  documented in the raw data.  Specifically, *** 1
3960 21 CFR 58.81(b) SOPs: required 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, *** 1
3991 21 CFR 58.113(a)(2) Mixtures: stability Not all test or control articles mixed with a carrier were tested by appropriate analytical methods to determine the stability of the test or control article in the mixture as required by the conditions of the study.  Specifically, *** 1
3993 21 CFR 58.120(a) Protocol: approved Not all studies had an approved written protocol that clearly indicated the objectives and all methods for the conduct of the study.  Specifically, *** 1
4013 21 CFR 58.130(e) Conduct: changes not obscuring original entries Not all changes in entries were made so as not to obscure the original entry, indicated the reason for such change, and were dated and signed or identified at the time of the change.  Specifically, *** 1
4016 21 CFR 58.185(a) Final report: non-existent A final report was not prepared for each nonclinical laboratory study.  Specifically, *** 1
4021 21 CFR 58.185(a)(5) Final report: stability of test and control articles The final study report did not include the stability of the test and control articles under the conditions of administration.  Specifically, *** 1
4035 21 CFR 58.190(a) Archives: data, documentation, specimens 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, *** 1
4042 21 CFR 58.195(b) Archives: retention for appropriate time Not all required documentation records, raw data, and specimens pertaining to a nonclinical laboratory study were retained in the archives for the appropriate time.  Specifically, *** 1
7230 21 CFR 50.27(b)(2) Short form: Oral presentation/signing A short form informed consent document [did not state that the required elements of informed consent had been presented orally to the subject or the subject's legally authorized representative] [was not signed by the subject or the subject's legally authorized representative] [was not signed by the witness].  Specifically, *** 1
7270 21 CFR 56.103(a) IRB review requirement A clinical investigation requiring prior submission to the FDA was initiated without [IRB review] [IRB approval] [being subject to continuing IRB review].  Specifically, *** 1
7277 21 CFR 56.107(d) One non-affiliate member The IRB does not include at least one member who is not otherwise affiliated with the institution, and who is not part of the immediate family of a person who is affiliated with the institution.  Specifically, *** 1
7305 21 CFR 56.110(b)(2) Minor changes The IRB used an expedited review procedure to review supposedly minor changes to previously-approved research, but the changes were not minor in nature.  Specifically, *** 1
7319 21 CFR 56.115(a)(3) Records of continuing review Records have not been [prepared] [maintained] of all continuing review activities.  Specifically, *** 1
7322 21 CFR 56.111 (a)(2) Risks to subjects reasonable The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result.  Specifically, *** 1
7323 21 CFR 56.111(a)(3) Selection of subjects equitable The IRB approved the conduct of research, but did not determine that the selection of subjects was equitable.  Specifically, *** 1
7352 21 CFR 50.51 Provisions for soliciting assent and permission For a clinical investigation in which no greater than minimal risk to children as subjects was presented, the IRB did not [find] [document] that adequate provisions had been made for [soliciting the assent of the children] [soliciting the permission of the parents or guardians of the children] as set forth at 21 CFR 50.55.  Specifically, *** 1
7363 21 CFR 50.55(f)  Documentation of permission by parents or guardian Permission by parents or guardians for the participation of children as subjects in a clinical investigation was not documented in accordance with and to the extent required by 21 CFR 50.27.  Specifically, *** 1
7364 21 CFR 50.55(g) Documentation of assent of children The IRB did not determine [whether] [how] assent must be documented when it made a determination that assent of children participating as subjects in a clinical investigation was required.  Specifically, *** 1
7378 21 CFR 50.27(a) Copy of consent form not provided 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, *** 1
7393 21 CFR 50.25(a)(8) Participation; refusal and discontinuance 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, *** 1
7452 21 CFR 312.56(c) IND safety report Failure to provide [FDA] [all participating investigators] with [a] [an adequate] written IND safety report.  Specifically, *** 1
7453 21 CFR 312.56(b) Investigator non-compliance 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, *** 1
7459 21 CFR 312.57(a) Records of receipt, shipment, disposition Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug.  Specifically, *** 1
7479 21 CFR 312.56(a) Monitoring investigations Failure to monitor the progress of an investigation conducted under your IND.  Specifically, *** 1
7488 21 CFR 312.59 Records of unused drug disposition Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance with 21 CFR Part 312.57.  Specifically, *** 1
7507 21 CFR 312.52(a) Transfer of obligations Transfer of obligations to a contract research organization [was not described in writing] [did not describe each of the obligations assumed by the contract research organization, where not all obligations were assumed]. Specifically, *** 1
7519 21 CFR 312.64(c) Final study report An adequate final report was not provided to the sponsor shortly after completion of the investigator's participation in the investigation.   Specifically, *** 1
7533 21 CFR 312.69 Controlled substances (investigator) Inadequate precautions to prevent theft or diversion with respect to [storage of] [access to] an investigational drug which is a controlled substance. Specifically, *** 1
7534 21 CFR 312.68 FDA access to clinical investigator records Failure to permit an authorized officer or employee of FDA to [have access to] [copy] [verify] records or reports.  Specifically, ***

1
7545 21 CFR 312.120(c) Foreign clinical trials Failure to assure that foreign clinical research was conducted in accordance with [the ethical principles stated in the ``Declaration of Helsinki''] [the laws and regulations of the country in which the research was conducted].  Specifically, ***



1
7555 21 CFR 312.53(d) Selecting monitors Monitors not qualified by experience and training were selected to monitor the progress of a clinical investigation.   Specifically, *** 1
7557 21 CFR 312.56(b) Notification of FDA of termination of investigator Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.  Specifically, *** 1
7558 21 CFR 312.57(c) Record retention requirement Records and reports were not retained for two years after [marketing application approval] [discontinuance of the investigation and notification of FDA]. Specifically*** 1
7629 21 CFR 312.56(c) Annual report Failure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation.  Specifically, *** 1
7632 21 CFR 312.6(a) Required label statement 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 1
7652 21 CFR 56.113 Reporting 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, *** 1
7658 21 CFR 50.25(b)(2) Termination by investigator The informed consent document did not include a statement of anticipated circumstances under which the subject's participation might be terminated by the investigator, without regard to the subject's consent.  Specifically, *** 1
7659 21 CFR 50.25(a)(6) Compensation, medical treatment in event of injury For research involving more than minimal risk, the informed consent document lacked an explanation as to whether any [compensation] [medical treatments] were available if injury occurred, and, if so, [of what they consisted] [where further information might be obtained].  Specifically, *** 1
7664 21 CFR 50.20 Circumstances of obtaining consent 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, *** 1
7679 21 CFR 56.106(a) IRB for CI's in support of research/marketing permits An individual authorized to act on behalf of an IRB which reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products has not submitted registration information.  Specifically, *** 1
7692 21 CFR 56.106(e) Changes in contact or chairperson information 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, ***

1

Cite Id Reference Number Short Description Long Description Frequency
3130 21 CFR 820.100(a) Lack of or inadequate procedures Procedures for corrective and preventive action have not been [adequately] established. Specifically, *** 400
14713 21 CFR 820.198(a) Lack of or inadequate complaint procedures  Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,***  269
479 21 CFR 820.50 Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.  Specifically, *** 138
546 21 CFR 820.75(a) Lack of or inadequate process validation  A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures.  Specifically, *** 137
630 21 CFR 803.17 Lack of Written MDR Procedures Written MDR procedures have not been [developed] [maintained] [implemented].  Specifically, *** 127
3282 21 CFR 820.90(a) Nonconforming product,  Lack of or inadequate procedures  Procedures have not been [adequately] established to control product that does not conform to specified requirements.  Specifically, ***  127
3696 21 CFR 820.100(b) Documentation Corrective and preventive action activities and/or results have not been [adequately] documented.  Specifically, ***   115
3103 21 CFR 820.30(i) Design changes - Lack of or Inadequate Procedures Procedures for design change have not been [adequately] established.  Specifically,*** 80
2327 21 CFR 820.22 Quality audits - Lack of or inadequate procedures  Procedures for quality audits have not been [adequately] established. Specifically, ***  78
3125 21 CFR 820.80(d) Lack of or inadequate final acceptance procedures  Procedures for finished device acceptance have not been [adequately] established. Specifically, ***  67
3331 21 CFR 820.181 DMR - not or inadequately maintained  A device master record has not been [adequately] maintained.  Specifically, *** 64
14722 21 CFR 820.40 Procedures not adequately established or maintained Document control procedures have not been adequately [established] [maintained].  Specifically,***  61
3680 21 CFR 820.70(a) Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been [adequately] established.   Specifically, ***  59
3168 21 CFR 820.198(a) Complaints  Complaint files are not [adequately] maintained.  Specifically, ***  54
3678 21 CFR 820.30(g) Design Validation - Risk analysis not performed/inadequate  Risk analysis [was not performed] [is inadequate] [is incomplete].  Specifically, ***  54
3172 21 CFR 820.198(c) Investigation of device failures  Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, ***  52
3233 21 CFR 820.72(a) Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established.  Specifically, *** 52
14712 21 CFR 820.184 DHR - not or inadequately maintained  A device history record has not been [adequately] maintained.  Specifically, *** 52
3159 21 CFR 820.184 DHR content  The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820].



49
2350 21 CFR 820.25(b) Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***  46
2371 21 CFR 820.30(a) Design control - no procedures  Procedures for design control have not been established.  Specifically,***  46
3121 21 CFR 820.80(b) Lack of or inadequate receiving acceptance procedures  Procedures for acceptance of incoming product have not been [adequately] established. Specifically, *** 46
3160 21 CFR 820.184 Lack of or inadequate DHR procedures  Procedures for device history records have not been [adequately] established.  Specifically,***  45
3120 21 CFR 820.80(a) Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been [adequately] established.  Specifically,*** 44
541 21 CFR 820.70(c) Environmental control  Lack of or inadequate procedures  Procedures to control environmental conditions have not been [adequately] established.  Specifically, *** 40
3666 21 CFR 820.20(c) Management review - Lack of or inadequate procedures  Procedures for management review have not been [adequately] established.  Specifically,***  40
3101 21 CFR 820.30(g) Design validation- Lack of or inadequate procedures  Procedures for design validation have not been [adequately] established.  Specifically,***  38
732 21 CFR 803.50(a)(2) Report of Malfunction 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, *** 35
3117 21 CFR 820.70(i) Software validation for automated processes Software used as part of [production] [the quality system] has not been [adequately] validated for its intended use according to an established protocol.  Specifically, *** 35
3128 21 CFR 820.90(a) Nonconforming product control Products that do not conform to specifications are not adequately controlled. Specifically, *** 34
3104 21 CFR 820.30(j) Design history file 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].   32
3375 21 CFR 820.198(e) Records of complaint investigation  Records of complaint investigations do not include required information.  Specifically, ***  31
537 21 CFR 820.70(a) Production processes Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications.  Specifically, ***  30
447 21 CFR 820.40 Lack of procedures, or not maintained   Document control procedures have not been [established] [maintained].  Specifically,***  29
3669 21 CFR 820.20(c) Management review - defined interval, sufficient frequency  Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system [at defined intervals] [with sufficient frequency].  Specifically, ***  29
3837 21 CFR 820.25(b) Training records  Personnel training is not documented. Specifically, *** 29
731 21 CFR 803.50(a)(1) Report of Death or Serious Injury 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, *** 28
3118 21 CFR 820.75(a) Documentation Process validation [activities] [results] have not been  [documented] [approved] [adequately documented] [adequately approved].  Specifically, *** 28
3119 21 CFR 820.75(b) Lack/Inad procedure-Monitoring/Control of Validated Proces   Procedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifically, *** 28
14716 21 CFR 820.30(f) Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.  Specifically, ***  28
3127 21 CFR 820.80(e) Documentation 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, *** 27
486 21 CFR 820.50(a) Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established.   Specifically, *** 26
3427 21 CFR 820.50(a)(2) Supplier oversight The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, *** 26
3415 21 CFR 820.22 Quality Audit/Reaudit - conducted  Quality [audits] [reaudits] have not been performed.  Specifically, ***  24
4059 21 CFR 820.22 Quality Audits - defined intervals  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, ***  24
2650 21 CFR 820.30(f) Design verification - Lack of or inadequate procedures  Procedures for design verification have not been [adequately] established.  Specifically,***  22
3132 21 CFR 820.120 Lack of or inadequate procedures for labeling  Procedures to control labeling activities have not been [adequately] established. Specifically, ***  22
2302 21 CFR 820.20(e) Quality System Procedures Quality system procedures and instructions have not been established.  Specifically,***  21
2604 21 CFR 820.30(e) Design review - Lack of or inadequate procedures  Procedures for design review have not been [adequately] established.  Specifically,***  21
3263 21 CFR 820.250(b) Sampling plans  Sampling plans are not [written] [based on valid statistical rationale].  Specifically, ***  21
3285 21 CFR 820.90(b)(2) Product rework procedures, Lack of or inadequate procedures  Procedures for rework of nonconforming product have not been [adequately] established.  Specifically, ***  21
3426 21 CFR 820.50(a)(1) Documented evaluation  The evaluation of potential [suppliers] [contractors] [consultants] was not documented.  Specifically, ***  19
14720 21 CFR 820.50(a)(3) Acceptable supplier records, inadequate records  Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.  19
631 21 CFR 803.17(a)(1) Lack of System for Event Evaluations 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, *** 18
632 21 CFR 803.17(a)(2) Lack of System for Determining MDR Events 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, *** 18
3192 21 CFR 820.30(g) Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.  Specifically, *** 18
3262 21 CFR 820.250(a) Statistical techniques - Lack of or inadequate procedures  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,***  18
4191 21 CFR 806.10(a)(1) Report of risk to health A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.  Specifically, *** 18
539 21 CFR 820.70(b) Production and Process Change Procedures, lack of or Inad. Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established.  Specifically, ***  17
3676 21 CFR 820.30(f) Design verification - documentation  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, ***  17
419 21 CFR 820.20(b) Lack of or inadequate organizational structure  The organizational structure has not been [adequately] established and maintained to ensure that devices are [designed] [produced] in accordance with 21 CFR 820.  Specifically, ***  16
3226 21 CFR 820.70(g)(1) Maintenance schedule, Lack of or inadequate schedule  Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established.  Specifically, ***  16
3686 21 CFR 820.90(b)(2) Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been [fully] documented in the device history record.  Specifically, *** 16
3207 21 CFR 820.50(b) Supplier notification of changes There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service.  Specifically, *** 15
4070 21 CFR 820.30(g) Design validation - documentation  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, ***  15
2328 21 CFR 820.22 Quality audits - auditor independence  Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***  14
2968 21 CFR 812.100 Investigator non-compliance with agreement/plan/regulations An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations].  Specifically, *** 14
3108 21 CFR 820.70(e) Contamination control, Lack of or inadequate procedures  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, ***  14
3201 21 CFR 820.40(a) Not approved or obsolete document retrieval Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are being] used. Specifically, ***



14
14714 21 CFR 820.30(c)  Design input - Lack of or inadequate procedures Procedures for design input have not been [adequately] established.  Specifically,***  14
3345 21 CFR 820.200(a) Servicing - Lack of or inadequate procedures  Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been [adequately] established. Specifically, *** 13
2557 21 CFR 820.30(c) Design input - documentation  Design input requirements were not [adequately] documented.   Specifically, *** 12
2974 21 CFR 812.110(b) Investigator non-compliance with agreement/plan/regulations 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, *** 12
3266 21 CFR 820.86 Acceptance status   The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained].  Specifically, ***  12
3425 21 CFR 820.50(a)(1) Evaluation and Selection, Suppliers, Contractors, etc. Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements.  Specifically, ***  12
3677 21 CFR 820.30(g) Design validation - software validation not performed  Validation of device software [was not performed] [is inadequate] [is incomplete].  Specifically, ***  12
454 21 CFR 820.40(a) Document review, approval by designated individual Documents were  [not reviewed] [not approved] by designated individual(s) prior to issuance .  Specifically, *** 11
3231 21 CFR 820.70(i) Documentation of software validation 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, ***  11
3235 21 CFR 820.72(a) Equipment control activity documentation Equipment [calibrations] [inspections] [checks] [maintenance activities] have not been documented.  Specifically, *** 11
3236 21 CFR 820.72(b) Calibration procedures - content  Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action].  Specifically, *** 11
3286 21 CFR 820.90(b)(1) Procedures for product review,disposition lack of/inadequate Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been [adequately] established.  Specifically, *** 11
3671 21 CFR 820.25(a) Personnel  Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***  11
502 21 CFR 820.60 Identification procedures, Lack of or inadequate procedures  Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately] established.  Specifically, ***  10
633 21 CFR 803.17(a)(3) Lack of  System for Timely Submission of Reports The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to [FDA] [manufacturers].  Specifically, *** 10
2630 21 CFR 820.30(e) Design review - documentation  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, ***  10
3232 21 CFR 820.72(a) Equipment suitability & capability Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results].  Specifically, *** 10
3264 21 CFR 820.250(b) Sampling methods - Lack of or inadequate procedures  Procedures to ensure sampling methods are adequate for their intended use have not been [adequately] established.  Specifically,*** 10
4212 21 CFR 806.20(b)(4) Justification for not reporting 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,*** 10
3102 21 CFR 820.30(h) Design transfer - Lack of or inadequate procedures   Procedures for design transfer have not been [adequately] established.  Specifically,*** 9
3123 21 CFR 820.80(c) Lack of or inadequate In-process acceptance procedures  Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***  9
3269 21 CFR 820.80(b) Incoming acceptance records, documentation  Acceptance or rejection of incoming product was not documented. Specifically, *** 9
3432 21 CFR 820.75(b)(2) Documentation of validated process performance 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, *** 9
14505 21 CFR 812.140(a)(3) Investigator's subject records inadequate Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current].  Specifically, *** 9
14710 21 CFR 820.150 Lack of or inadequate procedures for storage.  Procedures for the control of storage areas and stock rooms have not been [adequately] established.  Specifically,***  9
3170 21 CFR 820.198(b) Review and evaluation for investigation Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, *** 8
3203 21 CFR 820.40(b) Document change records, maintained. Records of changes to documents were not [adequately] maintained.  Specifically, *** 8
14718 21 CFR 820.30(g) Design validation - Risk analysis  Results of the design risk analysis were not [adequately] documented.  Specifically, *** 8
2293 21 CFR 820.20(d) Quality plan A quality plan has not been [adequately] established.  Specifically, *** 7
2431 21 CFR 820.30(b) Design plans- updated  Design plans were not [reviewed] [updated] [approved] as design and development evolves.  Specifically, ***  7
2928 21 CFR 812.40 Sponsors' general responsibilities 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, *** 7
3191 21 CFR 820.30(g) Design validation - production units  The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents].  Specifically, ***  7
3683 21 CFR 820.70(g) Equipment Installation, Placement, Specified Requirements 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, ***  7
14715 21 CFR 820.30(d) Design output - Lack of or inadequate procedures  Procedures for design output have not been [adequately] established.  Specifically,*** 7
2269 21 CFR 820.20(a) Quality policy and objectives  The [quality policy] [quality objectives] was/were not established by management with executive responsibility.  Specifically, *** 6
3171 21 CFR 820.198(b) Rationale documented for no investigation  Records for complaints where no investigation was made do not include required information.  Specifically, ***  6
3173 21 CFR 820.198(d) Evaluation, timeliness, identification 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, *** 6
3190 21 CFR 820.30(g) Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.  Specifically, *** 6
3409 21 CFR 820.200(d) Service reports   Service reports [are not documented] [do not include the required information].  Specifically, ***  6
3433 21 CFR 820.75(c) Process changes - review, evaluation and revalidation A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, *** 6
3668 21 CFR 820.20(c) Management review dates The results and/or dates of management reviews are not documented. Specifically, *** 6
2430 21 CFR 820.30(b) Design plans - Lack of or  inadequate  Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established.  Specifically, *** 5
3111 21 CFR 820.70(f) Buildings Buildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations] [prevent mix-ups] [assure orderly handling of product].  Specifically, ***  5
3175 21 CFR 820.186 QSR  The quality system record has not been [adequately] maintained.  Specifically, ***  5
3199 21 CFR 820.40(a) Document review, approval documentation  The documentation of approval of documents does not include [the document approval date] [the signature of the approving official].  Specifically, *** 5
3237 21 CFR 820.72(b) Remedial action 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, *** 5
3310 21 CFR 820.120(b) DHR documentation of label release {see also 820.184} The DHR does not include [complete] records of examination and release of device labeling, including date and signature of the examiner.  Specifically, *** 5
3434 21 CFR 820.75(c) Documentation - review in response to changes or deviations 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, *** 5
4192 21 CFR 806.10(a)(2) Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.  Specifically, *** 5
14711 21 CFR 820.160(a) Lack of or inadequate procedures for distribution Procedures for control and distribution of finished devices have not been [adequately] established.  Specifically,*** 5
14717 21 CFR 820.30(g) Design validation - software validation documentation  Results of the validation of the device software were not [adequately] documented.  Specifically, *** 5
14721 21 CFR 820.70(g)(2) Periodic equipment inspections  Periodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance schedules [were not documented].  Specifically, ***  5
635 21 CFR 803.17(b)(1) Info evaluated to determine if event was reportable 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, *** 4
733 21 CFR 803.50(b)(1) Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer.  Specifically, *** 4
3149 21 CFR 820.180 Availability 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, ***  4
3206 21 CFR 820.50(b) Approval, inadequate purchasing data 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, ***  4
3313 21 CFR 820.120(d) Records, DHR {see also 820.184(e)} Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.  Specifically, *** 4
4057 21 CFR 820.20(a) Management ensuring quality policy is understood Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization.  Specifically, ***  4
4193 21 CFR 806.10(b) Time to report - 10 days 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, *** 4
2985 21 CFR 812.140(a)(3)(ii) Investigator records of relevant observations inadequate 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, *** 3
3139 21 CFR 820.140 Lack of or inadequate procedures for handling Procedures for product handling have not been [adequately] established.  Specifically,***



3
3204 21 CFR 820.40(b) Change records, content 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, ***



3
3323 21 CFR 820.170(b) Installer records  The person installing the device did not [adequately] document the inspection and test results to demonstrate proper installation.  3
3328 21 CFR 820.180(b) Retention period Required records are not retained for [the design and expected life of the device] [at least 2 years from the date of release of the device for commercial distribution].  Specifically, *** 3
3347 21 CFR 820.200(c) Service reports/MDRs/complaints  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, ***  3
3372 21 CFR 820.198(d) Records of MDR Investigation  Investigation records of MDR reportable complaints do not include required information.  Specifically, ***  3
14511 21 CFR 812.2(b) Abbreviated requirements / non-significant risk study 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, *** 3
14516 21 CFR 812.25(e) Sponsor's lack of written monitoring procedures There are no written procedures for monitoring an investigational device study.  Specifically,*** 3
642 21 CFR 803.18(b)(1)(i) Adverse events--all info not in file MDR event files do not contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making process used to determine if an event was or was not reportable.  Specifically, *** 2
2930 21 CFR 812.42 Sponsor began study before IRB/FDA approval [An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval]. Specifically, *** 2
2970 21 CFR 812.100 Investigator lack of informed consent Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, *** 2
2981 21 CFR 812.140(a)(2)(i) Investigator device accountability inadequate Records of [receipt] [use] [disposal] of a device that relate to the [type and quantity] [dates of receipt] [batch number or code mark] of the device are not all [accurate] [complete] [current].  Specifically, *** 2
2984 21 CFR 812.140(a)(3)(i) Investigator records of informed consent inadequate Records documenting that informed consent was obtained for each subject prior to participation in the study are not all [accurate] [complete] [current].  Specifically, *** 2
3198 21 CFR 820.40(b) Document changes, review and approval, communication  Changes to documents were not [reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval] [communicated to appropriate personnel in a timely manner].  Specifically, ***  2
3200 21 CFR 820.40(a) Document locations, Dissemination, etc. Documents were not available at all locations for which they are designated, used, or otherwise necessary.  Specifically, *** 2
3224 21 CFR 820.70(g)(2) Periodic equipment inspection lack of or inadequate procedu  Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately] established.  Specifically, ***  2
3239 21 CFR 820.72(b) Remedial action - documentation Evaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, *** 2
3270 21 CFR 820.80(c) Documentation In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, *** 2
3309 21 CFR 820.120(b) Examination for accuracy Labeling was not sufficiently examined by a designated individual for accuracy including [the correct expiration date] [control numbers] [storage instructions] [handling instructions] [certain additional processing instructions] before release.  Specifically, *** 2
3343 21 CFR 820.198(e) Maintained Records of complaint investigations are not maintained by the formally designated unit. Specifically, *** 2
3346 21 CFR 820.200(b) Analyzing service report Service reports were not analyzed following appropriate statistical methods. Specifically, *** 2
3674 21 CFR 820.30(d) Design output - documentation  Design output was not [adequately] documented before release.  Specifically, *** 2
3682 21 CFR 820.70(d) Implementing Personnel Procedures, Health, Cleanliness.  Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented.  Specifically, *** 2
3841 21 CFR 820.90(b)(2) Product rework adverse effects {see also 820.184} 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, *** 2
4208 21 CFR 806.20(a) Records not kept There is no record maintained of a correction or removal action that was not required to be reported to FDA.   Specifically,*** 2
4437 21 CFR 803.40(b) Report of malfunction likely to cause death or injury 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, *** 2
7012 21 CFR 812.100 Investigator lack of control of investigational devices Devices under investigation were not properly controlled.  Specifically, *** 2
7013 21 CFR 812.110(d) Inadequate financial disclosure by investigator 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, *** 2
650 21 CFR 803.18(e) Results of evaluation not in mfr's MDR file The results of the evaluation of each event are not documented and maintained in the manufacturer's MDR event file.  Specifically, *** 1
812 21 CFR 803.56 Submission Within One Month 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, *** 1
2339 21 CFR 820.22 Quality Audit/Reaudit - documentation   The dates of quality [audits] [reaudits] have not been documented.  Specifically, ***  1
2602 21 CFR 820.30(d) Design output - review and approval  Design output was not [reviewed] [approved] before release.  Specifically, ***  1
2933 21 CFR 812.43(a) Investigator(s) not qualified One or more investigators were selected who were not qualified by [training] [experience] to investigate a device.  Specifically, *** 1
2935 21 CFR 812.43(b) Sponsor shipped devices to unqualified person(s) Investigational devices were shipped to individuals who were not qualified investigators participating in the investigation.  Specifically, *** 1
2982 21 CFR 812.140(a)(2)(ii) Investigator records of persons receiving devices inadequate Records of persons who [received] [used] [disposed] of each device are not all [accurate] [complete] [current]. Specifically, *** 1
2991 21 CFR 812.140(b)(1) Sponsor correspondence records inadequate Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA], including required reports are not all [accurate] [complete] [current].  Specifically, *** 1
2993 21 CFR 812.140(b)(2) Sponsor device disposition records inadequate Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [accurate] [complete] [current].  Specifically, *** 1
3002 21 CFR 812.140(b)(5) Sponsor records of adverse device effects & complaints Records concerning [anticipated adverse device effects] [unanticipated adverse device effects] [complaint] reports are not all [accurate] [complete] [current]. Specifically, *** 1
3007 21 CFR 812.140(d) Record retention inadequate Required records were not all maintained [during the investigation] [for a period of two years after the date on which an investigation was terminated or completed] [for a period of two years after the date that the records were no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol].  Specifically, *** 1
3021 21 CFR 812.150(a)(1) Investigator report of unanticipated adverse effects 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, *** 1
3049 21 CFR 812.150(b)(5) Sponsor progress reports for significant risk study Progress reports for a significant risk device study were not submitted [at required intervals] [at least yearly] to [FDA] [all reviewing IRBs].  Specifically, *** 1
3063 21 CFR 812.140(a)(3)(iii) Investigator records of exposure to device inadequate Records of each subject's exposure to the device, including [the date and time of each use] [the use of any other therapy] are not all [accurate] [complete] [current].  Specifically, *** 1
3109 21 CFR 820.70(d) Personnel requirements, Lack of or inadequate requirements  Requirements have not been [adequately] established to address personnel [health] [cleanliness] [personal practices] [clothing].  Specifically, ***  1
3113 21 CFR 820.70(g) Equipment design and installation  Equipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***  1
3115 21 CFR 820.70(h) Use and removal, Lack of or inadequate procedures  Procedures for the use and removal of manufacturing material have not been [adequately] established.  Specifically, ***  1
3138 21 CFR 820.130 Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.  Specifically, ***  1
3147 21 CFR 820.170(a) Lack of or inadequate instructions [Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established.  Specifically,*** 1
3193 21 CFR 820.30(g) Design validation - simulated testing The design was not validated under actual or simulated use conditions.  Specifically, ***  1
3312 21 CFR 820.120(d) Mixups Labeling and packaging operations were not controlled to prevent labeling mix-ups.  Specifically, *** 1
3314 21 CFR 820.120(e) Control number {see also 820.65, 820.184(f)} Although a control number is required for this type of device, the device does not carry its control number through distribution.  Specifically, *** 1
3383 21 CFR 820.198(g) Foreign complaint files  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, ***  1
3699 21 CFR 820.160(b) Distribution records  Distribution records [were not maintained] [do not include or refer to the location of required information].  Specifically, *** 1
4201 21 CFR 806.10(c)(8) Illness report Illnesses or injuries that have occurred with use of devices subject to corrections or removals have not been reported.  Specifically,*** 1
4204 21 CFR 806.10(c)(11) Domestic & foreign consignees The [names] [addresses] [telephone numbers] of all domestic and foreign consignees of devices subject to correction or removal actions and number of devices distributed to each consignee were not reported.  Specifically,*** 1
4211 21 CFR 806.20(b)(3) Events A description of the events that led to the correction or removal actions was not contained in the record.  Specifically,*** 1
6800 21 CFR 807.20 Establishment not registered An establishment for which registration is required has not been registered.  Specifically, *** 1
6804 21 CFR 807.21(b) Listing not updated Existing device information changed, but the listing was not updated during [June] [December] (or earlier) as required.  Specifically, *** 1
6849 21 CFR 812.5(a) Label does not contain required information 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, *** 1
14523 21 CFR 812.43(c) No investigator agreement A signed investigator agreement was not obtained from each participating investigator .  Specifically,*** 1
14719 21 CFR 820.30(h) Incorrect translation to production specifications The device design was not correctly translated into production specifications.  Specifically, ***  1
14730 21 CFR 860.7(g)(2) Rpts of safety & effectiveness, adulteration or misbranding The [manufacturer] [importer] [distributer] failed to [make required reports] [provide other information] bearing on the classification of a device and indicating whether [there is a reasonable assurance of the safety and effectiveness of the device] [it is adulterated or misbranded under the act].  Specifically*** 1
14732 21 CFR 860.7(g)(1)  Responsibility to provide valid scientific evidence  The [manufacturer] [importer] failed to [assure that adequate, valid scientific evidence exists] [present to the FDA adequate, valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended uses and conditions of use].  Specifically*** 1
Cite Id Reference Number Short Description Long Description Frequency
1105 21 CFR 211.22(d) Procedures not  in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed].  Specifically, *** 185
3603 21 CFR 211.160(b) Scientifically sound laboratory controls 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, *** 124
2027 21 CFR 211.192 Investigations of discrepancies, failures 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, *** 100
1361 21 CFR 211.100(a) Absence of Written Procedures  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, *** 91
1215 21 CFR 211.67(b) Written procedures not established/followed 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, ***

68
1883 21 CFR 211.165(a) Testing and release for distribution 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, *** 64
1263 21 CFR 211.68(b) Computer control of master formula records 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, *** 62
1451 21 CFR 211.113(b) Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed].  Specifically, *** 62
1274 21 CFR 211.68(a) Calibration/Inspection/Checking not done Routine [calibration] [inspection] [checking] of  [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance.  Specifically, *** 61
1914 21 CFR 211.166(a) Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.  Specifically, *** 61
3585 21 CFR 211.110(a) Control procedures to monitor and validate performance 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, ***

56
1213 21 CFR 211.67(a) Cleaning / Sanitizing / Maintenance 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, *** 54
1112 21 CFR 211.25(a) Training--operations, GMPs, written procedures 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, *** 53
2009 21 CFR 211.188 Prepared for each batch, include complete information 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, *** 51
1890 21 CFR 211.165(e) Test methods  The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].  Specifically, *** 50
1434 21 CFR 211.42(c)(10)(iv) Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.  Specifically, *** 47
1177 21 CFR 211.63 Equipment Design, Size and Location 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, *** 44
1358 21 CFR 211.100(b) SOPs not followed / documented 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, *** 43
4391 21 CFR 211.180(e)(2) Items to cover on annual reviews 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, *** 41
2031 21 CFR 211.194(a) Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.  Specifically, , *** 39
1435 21 CFR 211.42(c)(10)(v) Cleaning System Aseptic processing areas are deficient regarding the system for cleaning  and disinfecting the [room] [equipment] to produce aseptic conditions.  Specifically, *** 38
9001 21 CFR 211.22(a) Lack of quality control unit There is no quality control unit.  Specifically, *** 38
2419 21 CFR 211.198(a) Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed].  Specifically, *** 37
1450 21 CFR 211.113(a) Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed].  Specifically, *** 33
1111 21 CFR 211.25(a) Training , Education , Experience overall Employees  engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions.  Specifically, *** 31
1452 21 CFR 211.113(b) Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include [adequate] validation of the sterilization process.  Specifically, *** 30
1133 21 CFR 211.25(a) GMP Training Frequency 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, *** 29
4402 21 CFR 211.192 Written record of investigation incomplete 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, *** 29
1809 21 CFR 211.160(a) Following/documenting laboratory controls Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance].  Specifically, *** 28
1885 21 CFR 211.165(b) Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.  Specifically, *** 27
2012 21 CFR 211.188(b) Batch production and Batch Control Record Requirements 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, *** 26
4352 21 CFR 211.160(b)(4) Calibration - at intervals, written program, remedial action 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, *** 26
2026 21 CFR 211.192 Quality control unit review of records 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, *** 25
2401 21 CFR 211.194(a)(4) Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.  Specifically, *** 25
4342 21 CFR 211.142(b) Storage under appropriate conditions Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected.  Specifically, *** 25
4389 21 CFR 211.198(a) Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed].  Specifically, *** 25
1448 21 CFR 211.111 Establishment of time limitations Time limits are not established when appropriate  for the completion of each production phase to assure the quality of the drug product.  Specifically, *** 24
3565 21 CFR 211.58 Buildings not maintained in good state of repair Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair.  Specifically, *** 24
3602 21 CFR 211.160(a) Deviations from laboratory control requirements Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified].  Specifically, *** 23
1844 21 CFR 211.84(d)(2) Establish reliability of supplier's C of A 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, *** 22
1942 21 CFR 211.180(e) Records reviewed annually  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, *** 22
3572 21 CFR 211.100(b) Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not [recorded] [justified].  Specifically, *** 22
4314 21 CFR 211.84(d)(2) Reports of Analysis (Components) 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, *** 22
1810 21 CFR 211.160(a) Lab controls established, including changes 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, *** 21
1975 21 CFR 211.182 Written records kept in individual logs Written records of major equipment [cleaning] [maintenance] [use]  are not included in individual equipment logs.  Specifically, *** 21
3632 21 CFR 211.170(b) Annual visual exams of drug products 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, *** 21
4576 21 CFR 211.192 No written record of investigation 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, *** 20
6730 21 CFR 314.80(b) Failure to develop written procedures Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences. Specifically, *** 20
2028 21 CFR 211.192 Extent of discrepancy, failure  investigations 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, *** 19
3571 21 CFR 211.100(a) Changes to Procedures Not Reviewed, Approved Changes to written procedures are  not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, *** 19
1033 21 CFR 211.22(a) Authority lacking to review records, investigate errors The quality control unit lacks authority  to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred].  Specifically, *** 18
1787 21 CFR 211.80(a) Procedures To Be in Writing 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, *** 18
1912 21 CFR 211.166(a) Written program not followed The written stability testing program is not followed.  Specifically, *** 18
1495 21 CFR 211.122(a) Written procedures describing in detail 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, *** 17
1540 21 CFR 211.125(a) Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.  Specifically, *** 17
3561 21 CFR 211.56(b) Written sanitation procedures lacking 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, ***    17
1159 21 CFR 211.28(a) Clothing appropriate for duties performed Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not  appropriate for the duties they perform.  Specifically, *** 16
1842 21 CFR 211.84(d)(1) Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.  Specifically,*** 16
1626 21 CFR 211.130 Procedures are written, and followed Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed].  Specifically, *** 15
1943 21 CFR 211.180(e)(1) Review of representative number of batches 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, *** 15
3547 21 CFR 211.46(b) Equipment for Environmental Control 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, *** 15
1767 21 CFR 211.137(a) Expiration date lacking 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, *** 14
1395 21 CFR 211.103 Actual vs. theoretical yields not determined 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, *** 13
1920 21 CFR 211.166(a)(3) Valid stability test methods The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods.  Specifically, *** 13
3559 21 CFR 211.56(a) Sanitation--buildings not clean, free of infestation 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, *** 13
4303 21 CFR 211.67(b) Written procedures fail to include 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, *** 13
4306 21 CFR 211.80(a) Written Procedures Not Followed Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].  Specifically, *** 13
4340 21 CFR 211.142 Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not [established] [followed].  Specifically, *** 13
6732 21 CFR 314.80(c)(1)(i) Late submission of 15-day report 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, *** 13
1049 21 CFR 211.22(a) Approve or reject components, products  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, *** 12
1790 21 CFR 211.80(b) Handling and Storage to Prevent Contamination There was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination.  Specifically, *** 12
1194 21 CFR 211.42(c) Defined areas of adequate size for operations The [separate or defined areas] [control systems] necessary to prevent contamination or mix-ups are deficient.  Specifically, *** 11
1833 21 CFR 211.84(d)(1) Identity Testing of Each Component 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, *** 11
1891 21 CFR 211.165(f) Failing drug products not rejected Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected.  Specifically, *** 11
3613 21 CFR 211.160(b)(4) Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed].  Specifically, *** 11
1098 21 CFR 211.22(c) Approve or reject procedures or specs The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products.  Specifically, *** 10
1227 21 CFR 211.67(c) Cleaning/maintenance records not kept Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment.  Specifically, *** 10
1433 21 CFR 211.42(c)(10)(iii) Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.  Specifically, *** 10
2011 21 CFR 211.188(a) Accurate reproduction 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, *** 10
2205 21 CFR 211.186(b)(9) Manufacturing Instructions and Specifications 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, *** 10
18008 FDCA 503B(a)(10) Drug product label, outsourcer facility The labels of your outsourcing facility's drug products are deficient.  Specifically,*** 10
1169 21 CFR 211.42(a) Buildings of Suitable Size, Construction, Location 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, *** 9
1251 21 CFR 211.42(c)(1) Incoming material area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related 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, *** 9
1411 21 CFR 211.105(b) Distinctive ID or code not recorded in batch record 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, *** 9
1777 21 CFR 211.150(b) Distribution Recall System The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.  Specifically,  *** 9
1886 21 CFR 211.165(c) Sampling and testing plans not described 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, *** 9
1926 21 CFR 211.166(b) Adequate number of batches on stability 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, *** 9
1932 21 CFR 211.167(a) Sterility/pyrogen-free testing  Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements.  Specifically, *** 9
2007 21 CFR 211.186(a) Signature and checking of records -- 2 persons 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, *** 9
3583 21 CFR 211.110(a) Written in-process control procedures 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, *** 9
3611 21 CFR 211.160(b)(3) Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products.  Specifically, *** 9
1079 21 CFR 211.22(a) Contract drug products--lack of responsibility The quality control unit lacks responsibility for approving or rejecting drug products [manufactured] [processed] [packed] [held] under contract by another company.  Specifically, *** 8
1388 21 CFR 211.101(d) Component addition checked by 2nd person Each component is not added to a batch by one person and verified by a second person.  Specifically, *** 8
1728 21 CFR 211.87 Retest of approved components/containers/closures 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, ***  8
1801 21 CFR 211.84(a) Components withheld from use pending release 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, *** 8
1879 21 CFR 211.180(c) Records not made readily available to FDA 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, *** 8
2008 21 CFR 211.186(a) Written procedures followed Procedures for the preparation of master production and control records are not [described in a written procedure] [followed].  Specifically, ***  8
2619 21 CFR 211.198(b)(2) Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].  Specifically, *** 8
3567 21 CFR 211.84(d)(2) Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.  Specifically, *** 8
3569 21 CFR 211.89 Quarantine of Rejected Components et. al. 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, *** 8
4305 21 CFR 211.68(b) Backup data not assured as exact and complete Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems.  Specifically, *** 8
4357 21 CFR 211.166(a) Results not used for expiration dates, storage cond. Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates].  Specifically, *** 8
4382 21 CFR 211.198(b)(2) Written record of complaint to include findings, follow-up Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up].  Specifically, *** 8
4401 21 CFR 211.186(b)(9) Complete instructions, procedures, specifications et. al. Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed].  Specifically, *** 8
8911 21 CFR 314.81(b)(1)(ii) Failure to meet specifications 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, *** 8
1256 21 CFR 211.68(b) Backup file not maintained Failure to maintain a backup file of data entered into the computer or related system.  Specifically, *** 7
1261 21 CFR 211.68(a) Written calibration / inspection records not  kept Records of the [calibration checks] [inspections] of  automatic, mechanical or electronic equipment, including computers or related systems are not maintained.  Specifically, *** 7
1550 21 CFR 211.125(f) Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, *** 7
1851 21 CFR 211.84(e) Rejecting  When Specifications Not Met 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, *** 7
1933 21 CFR 211.167(a) Sterility/pyrogens - test methods written, followed Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed].  Specifically, *** 7
2034 21 CFR 211.194(d) Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices].  Specifically, *** 7
2406 21 CFR 211.194(a)(8) Identification of Person Performing Review of Lab Records Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy.  Specifically, *** 7
4387 21 CFR 211.198(a) Reporting of adverse drug experience to FDA 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, *** 7
4413 21 CFR 211.194(a)(8) Second person sign off 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, *** 7
8912 21 CFR 314.81(b)(2) Timely submission 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, *** 7
1134 21 CFR 211.25(b) Supervisor Training/Education/Experience 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, *** 6
1270 21 CFR 211.68(b) input/output verification Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy.  Specifically, ***  6
1413 21 CFR 211.42(c)(5) Mfg / Processing Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.  Specifically, *** 6
1436 21 CFR 211.42(c)(10)(vi) Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.  Specifically, ***

6
1843 21 CFR 211.84(d)(2) Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically,  *** 6
3557 21 CFR 211.52 Washing and toilet facilities are deficient Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness].  Specifically, *** 6
3570 21 CFR 211.100(a) Approval and review of procedures Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit].  Specifically, *** 6
3610 21 CFR 211.160(b)(3) Drug product sample Drug product samples are not [representative of the entire batch] [properly identified].  Specifically, *** 6
3614 21 CFR 211.160(b)(4) Written calibration procedures 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, *** 6
3616 21 CFR 211.165(d) Acceptance criteria for sampling & testing 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, *** 6
3629 21 CFR 211.170(b) Reserve samples identified, representative, stored 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, *** 6
4406 21 CFR 211.194(a)(2) Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use.  Specifically, *** 6
4410 21 CFR 211.194(a)(5) Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test.  Specifically, ***  6
4418 21 CFR 211.42(b) Adequate space lacking  to prevent mix-ups and contamination 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, ***  6
1086 21 CFR 211.22(b) Adequate lab facilities not available  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, *** 5
1418 21 CFR 211.42(c)(7) Quarantined Drug Products Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.  Specifically, *** 5
2033 21 CFR 211.194(c) Testing and standardization of standards et. al. Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions].  Specifically, *** 5
3592 21 CFR 211.110(c) In-process materials characteristics testing 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, *** 5
4338 21 CFR 211.150(b) Recall facilitation 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, *** 5
4353 21 CFR 211.160(b)(4) Instruments, apparatus, et. al. not meeting specs The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed.   Specifically, *** 5
4368 21 CFR 211.188(b)(12) Investigations made into any unexplained discrepancy 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, *** 5
4388 21 CFR 211.198(a) Complaints reviewed by Quality Control Unit 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, *** 5
4409 21 CFR 211.194(a)(4) Data secured in course of each test 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, *** 5
6832 21 CFR 314.80(c)(2) Late submission of annual safety reports 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, *** 5
1136 21 CFR 211.25(c) Inadequate number of  personnel The number of qualified  personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, *** 4
1162 21 CFR 211.28(a) Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.  Specifically, *** 4
1421 21 CFR 211.42(c)(10) Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.  Specifically,*** 4
1430 21 CFR 211.42(c)(10)(i) Floors, walls, ceiling surfaces Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,*** 4
1722 21 CFR 211.134(a) Correct labels during finishing operations 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, *** 4
1725 21 CFR 211.134(c) Examinations documented The results of the examination of the packaged and labeled products were not documented in the batch production or control records.  Specifically, *** 4
1774 21 CFR 211.142(a) Quarantine - actual practice Drug products are not quarantined before being released by the quality control unit.  Specifically, *** 4
1798 21 CFR 211.82(b) Quarantine Storage of Components Incoming [components] [drug product containers] [closures] are not stored under quarantine until they have been tested or examined, as appropriate, and released.  Specifically, *** 4
1802 21 CFR 211.84(b) Representative Samples Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination.  Specifically, *** 4
1846 21 CFR 211.84(d)(3) Establish reliability of supplier's C of A 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, *** 4
1868 21 CFR 211.94(b) Protection from external factors 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, *** 4
1869 21 CFR 211.94(c) Containers & Closures Clean, Sterilized, Pyrogen-free 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, *** 4
1922 21 CFR 211.166(a)(4) Testing in same container - closure system The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.  Specifically, ***  4
1928 21 CFR 211.166(c)(1) Homeopathic drugs, assessment of stability 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, *** 4
1976 21 CFR 211.182 Specific information required in individual logs Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].  Specifically, *** 4
2003 21 CFR 211.184(c) Individual inventory record Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product container] [drug product closure] with sufficient information to allow determination of any associated  batch or lot of drug product.  Specifically, *** 4
2020 21 CFR 211.188(b)(8) Labeling Control Records and Label Copies The batch production and control records are deficient in that they do not  include [complete labeling control records] [specimen] [copy] of labeling.  Specifically, *** 4
2044 21 CFR 211.196 Distribution Record Requirements 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, *** 4
2399 21 CFR 211.194(a)(2) Laboratory Test Method Verification 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, *** 4
3573 21 CFR 211.101(b) Measured components for manufacturing Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate].  Specifically, *** 4
3582 21 CFR 211.105(a) Identification of containers, lines, equipment 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, ***  4
3609 21 CFR 211.160(b)(2) In-process sample representation/identification In-process samples are not [representative] [properly identified]. Specifically, *** 4
4315 21 CFR 211.84(d)(2) Testing Each Component for Conformity with Specs Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically, *** 4
4336 21 CFR 211.150 Written distribution procedure Written distribution procedures are not [established] [followed].  Specifically, *** 4
4360 21 CFR 211.170(b) Reserve drug product sample quantity - all tests 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, *** 4
6830 21 CFR 314.80(c)(2) Interval 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, *** 4
6831 21 CFR 314.80(c)(2) Late submission of quarterly safety reports Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.  Specifically, *** 4
17741 21 CFR 212.30(b) Equipment not clean You did not implement procedures to ensure that all your equipment is clean.  Specifically, *** 4
1219 21 CFR 211.67(b)(2) Cleaning SOPs/schedules Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.  Specifically, *** 3
1220 21 CFR 211.67(b)(3) Cleaning SOPs/instructions 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, ***

3
1223 21 CFR 211.67(b)(5) Cleaning SOPs/equipment protection Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.  Specifically, *** 3
1396 21 CFR 211.42(c)(2) Rejected Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition.  Specifically,*** 3
1420 21 CFR 211.42(c)(9) Control / Lab Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations.  Specifically, *** 3
1496 21 CFR 211.122(a) Sampling/testing of labeling/packaging materials Labeling and packaging materials are not  [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product.  Specifically, *** 3
1505 21 CFR 211.122(d) Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel.  Specifically, *** 3
1506 21 CFR 211.122(e) Destruction of obsolete labeling Obsolete or outdated labels, labeling and packaging materials are not destroyed.  Specifically, *** 3
1632 21 CFR 211.130(c) Lot or control number assigned 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, *** 3
1876 21 CFR 211.180(b) Record maintenance 1 year (except exempt OTC) 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, *** 3
1917 21 CFR 211.166(a)(1) Sample size - test intervals 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, *** 3
1927 21 CFR 211.166(b) Accelerated stability studies Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not  supported with ongoing full shelf life studies.  Specifically, *** 3
2015 21 CFR 211.188(b)(3) Identification of Components and In-Process Materials 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, *** 3
2567 21 CFR 211.198(a) Adverse Drug Experience 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, *** 3
3548 21 CFR 211.46(c) Air filtration system lacking in production area The production area air supply lacks an appropriate air filtration system.  Specifically, *** 3
3550 21 CFR 211.46(c) Exhaust systems inadequate to control air contamination Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.  Specifically, *** 3
3553 21 CFR 211.48(a) Plumbing System Defects The plumbing system contains defects that could contribute to the  contamination of drug products.  Specifically, *** 3
3562 21 CFR 211.56(c) Written procedures lacking for use of pesticides etc. 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, *** 3
3581 21 CFR 211.101(d) Verification of component addition Each component is not added to the batch by one person and verified by a second person..  Specifically, *** 3
3639 21 CFR 211.204 Returned drug procedures in writing and followed Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed].  Specifically, *** 3
4307 21 CFR 211.80(d) Status of Each Lot Identified 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, *** 3
4351 21 CFR 211.160(b)(3) Drug products - samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified].  Specifically, *** 3
4366 21 CFR 211.188(a) Accurate reproduction included 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, ***

3
4373 21 CFR 211.188(b)(7) Actual yield, % of theoretical yield 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, *** 3
4399 21 CFR 211.186(b)(7) Theoretical yield statement including percentages 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, *** 3
4400 21 CFR 211.186(b)(8) Description of containers, labels, et. al. Master production and control records lack [a description of the drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling] [the signatures and dates entered by the person or persons responsible for the approval of labeling].  Specifically, *** 3
4407 21 CFR 211.194(a)(2) Reference and method not stated Laboratory records of methods of testing used do not [indicate the method] [provide the reference] when employing methods in [recognized standard references] [an approved new drug application and the referenced method is not modified].  Specifically, *** 3
17749 21 CFR 212.30(a) Prevention of contamination Your facilities are not adequate to ensure the prevention of contamination of [equipment] [product] by [substances] [personnel] [environmental conditions] that could reasonably be expected to have an adverse effect on product quality.  Specifically,*** 3
17763 21 CFR 212.20(d) Determination need for investigation When errors occurred or a production batch failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary. Specifically,*** 3
17932 21 CFR 212.60(b) Testing Procedures- Conformance to Standards Each laboratory did not have testing procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,*** 3
18009 FDCA 503B(a)(10) Container label, outsourcer facility The container labels of your outsourcing facility's drug products are deficient.  Specifically,*** 3
1174 21 CFR 211.42(b) Product flow through building is inadequate The flow  of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not designed to prevent contamination.  Specifically, *** 2
1384 21 CFR 211.101(c) Weighing/measuring/subdividing supervision Component [weighing] [measuring] [subdividing] operations are not adequately supervised.  Specifically, *** 2
1454 21 CFR 211.115(a) Reprocessing procedures not written or followed 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, *** 2
1546 21 CFR 211.125(d) Destruction of excess labels with lot numbers Excess labeling bearing lot or control numbers is not destroyed.  Specifically, *** 2
1770 21 CFR 211.137(d) Expiration date location on labeling Drug product expiration dates do not appear on the labeling in the manner prescribed by regulations.  Specifically, *** 2
1794 21 CFR 211.80(d) Disposition recorded by lot identification The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot.  Specifically, *** 2
1796 21 CFR 211.80(d) Identification of Each Lot in Each Shipment 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, ***  2
1797 21 CFR 211.82(a) Examination on receipt, before acceptance 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, *** 2
1803 21 CFR 211.84(b) Representative Samples Criteria The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria.  Specifically, *** 2
1818 21 CFR 211.84(c)(2) Appropriate Opening of Component Containers 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, *** 2
1852 21 CFR 211.94(a) Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are [reactive] [additive] [absorptive] so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.  Specifically, *** 2
1918 21 CFR 211.166(a)(2) Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing.  Specifically, *** 2
1957 21 CFR 211.180(e)(2) Review of problem drugs 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, *** 2
1978 21 CFR 211.182 Personnel  dating/signing equipment log The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log.  Specifically, *** 2
2035 21 CFR 211.194(e) Stability testing records not  included Laboratory records do not include complete records of all stability testing performed.  Specifically, *** 2
3545 21 CFR 211.44 Adequate lighting not provided Adequate lighting is not provided in all  areas.  Specifically, *** 2
3560 21 CFR 211.56(a) Trash and organic waste timely disposal There is no provision to hold and dispose of [trash] [organic waste matter] in a timely and sanitary manner.  Specifically, *** 2
3566 21 CFR 211.84(c)(4) Composite sample top/middle/bottom Sampling procedures are deficient regarding compositing for testing of samples collected from the top, middle, and bottom of the component container.  Specifically, *** 2
3588 21 CFR 211.110(a)(3) Mixing adequacy The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.  Specifically, *** 2
3591 21 CFR 211.110(b) In-process materials specifications 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, *** 2
3605 21 CFR 211.160(b)(1) Specification description of sample/testing 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, *** 2
3615 21 CFR 211.160(b)(4) Test devices not meeting specifications Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used.  Specifically, *** 2
3623 21 CFR 211.170(a) Active ingredient retained sample kept A sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained].   Specifically, *** 2
3641 21 CFR 211.204 Record information inclusions Records of returned drug products do not include the  [name] [labeled potency] [lot, control or batch number] [reason for return] [quantity] [date of disposition] [ultimate disposition].  Specifically, *** 2
4317 21 CFR 211.84(d)(3) Certificates of Testing (Containers, Closures) 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, *** 2
4321 21 CFR 211.101(b) Identification of new containers For components removed from the original containers, the new container fails to be identified with [component name or item code] [receiving or control number] [weight or measure] [batch for which component was dispensed including product name, strength and lot number].  Specifically, *** 2
4344 21 CFR 211.160(b)(1) Sampling and testing procedures described Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used.  Specifically, *** 2
4345 21 CFR 211.160(b)(1) Samples (various types) representative, identified properly 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, *** 2
4349 21 CFR 211.160(b)(2) In-process samples representative, identified properly Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified].  Specifically, *** 2
4354 21 CFR 211.165(d) Acceptance/Rejection Levels The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].  Specifically, *** 2
4359 21 CFR 211.170(b)(1) Retention time of reserve samples, in general You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.  Specifically, *** 2
4372 21 CFR 211.188(b)(8) Labeling control records including specimens or copies 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, *** 2
4375 21 CFR 211.188(b)(5) In-process and laboratory control results  Batch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced.  Specifically, *** 2
4377 21 CFR 211.188(b(3) Identification of each  component or in-process material 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, *** 2
4403 21 CFR 211.194(b) Test method modification records do not  include Records maintained of any modification of an established method employed in testing do not include [the reason for the modification] [the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method].  Specifically, *** 2
6728 21 CFR 314.80(b) Failure to review ADE information Adverse drug experience information obtained or otherwise received from any source was not [promptly] reviewed, including information from [commercial marketing experience] [post marketing clinical investigations] [post marketing epidemiological/surveillance activities] [reports in the scientific literature] [unpublished scientific papers].  Specifically, *** 2
6829 21 CFR 314.80(c)(2) Failure to report non-alert ADEs 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, *** 2
6833 21 CFR 314.80(c)(2)(ii)(A) Incomplete periodic safety report 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, *** 2
6842 21 CFR 314.80(j) Failure to maintain records 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, *** 2
17812 21 CFR 212.50 Adequate controls (general) 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,*** 2
17814 21 CFR 212.50(b) Records to document all steps You did not have master production and control records that document all steps in the PET drug production process.  Specifically,*** 2
17857 21 CFR 212.60(f) Lab written procedures Laboratory written procedures are not [established] [followed] to ensure that the lab equipment is routinely [calibrated] [inspected] [checked] [maintained].  Specifically,*** 2
17863 21 CFR 212.60(g)(3) Record of all test data Laboratory records did not contain a complete record of all data obtained in the course of each test.  Specifically,*** 2
17958 21 CFR 361.1(c)(2) Signatures of RDRC Chairman The RDRC Chairman did not sign all [applications] [minutes] [reports] of the committee.  Specifically, *** 2
17962 21 CFR 361.1(c)(2) Numerical votes not in the minutes of any RDRC meetings The minutes of an RDRC meeting did not include the numerical results of votes on protocols involving use in human subjects.  Specifically, *** 2
17993 21 CFR 361.1(f)(1) Packaging, labeling - Rx only 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, *** 2
1163 21 CFR 211.28(b) Habits of good sanitation & health  Production personnel were not practicing good sanitation and health habits.  Specifically, *** 1
1224 21 CFR 211.67(b)(6) Cleaning SOP/inspection Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.  Specifically, *** 1
1266 21 CFR 211.42(d) Penicillin processing area not  kept separate 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,  *** 1
1371 21 CFR 211.101(a) Batches Formulated to less than 100% Written production and control procedures  include batches formulated with the intent to provide less than  100 percent of the labeled or established amount of active ingredient.  Specifically, *** 1
1398 21 CFR 211.42(c)(3) Released Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of released [components] [drug product containers] [closures] [labeling].  Specifically, ***

1
1419 21 CFR 211.42(c)(8) Released Drug Products Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of drug products after release.   Specifically,*** 1
1456 21 CFR 211.115(b) Reprocessing/quality control unit Reprocessing  was  performed without the [review] [approval] of the quality control unit.  Specifically, *** 1
1504 21 CFR 211.122(d) Labels and labeling stored  separately  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, *** 1
1541 21 CFR 211.125(b) Examination of issued labels 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, *** 1
1545 21 CFR 211.125(c) Label reconciliation discrepancies evaluation/investigation Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated] [investigated].  Specifically, *** 1
1629 21 CFR 211.130(a) Prevention of cross contamination, mix-ups There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.  Specifically, ***  1
1630 21 CFR 211.130(b) Unlabeled filled containers controls 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, *** 1
1636 21 CFR 211.130(e) Packaging line inspection before use 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, *** 1
1637 21 CFR 211.130(e) Packaging line inspection after use Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.  Specifically, *** 1
1726 21 CFR 211.86 Rotation of components/containers/closures There is a lack of rotation so that the oldest approved stock of [components] [drug product containers] [closures] is used first.  Specifically, ***  1
1776 21 CFR 211.150(a) Distribution of oldest approved drugs The oldest approved stock of drug products are not distributed first and there is no justification for this practice.  Specifically,  *** 1
1791 21 CFR 211.80(c) Storage off Floor, Spaced Suitably Bagged or boxed components of drug product [containers] [closures] are not [stored off the floor] [suitably spaced to allow cleaning and inspection].  Specifically, *** 1
1823 21 CFR 211.84(c)(4) Top/Middle/Bottom container sampling Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container.  Specifically, ***

1
1825 21 CFR 211.84(c)(6) Identifying Containers Sampled Markings of containers from which samples have been taken are deficient in that they do not show that samples have been removed from them. Specifically,  ***

1
1845 21 CFR 211.84(d)(3) Container/Closure Written Test Procedure 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,  *** 1
1849 21 CFR 211.84(d)(6) Objectionable microbiological contamination Each lot of a [component] [drug product containers] [closures] liable to objectionable  microbiological contamination is deficiently subjected to microbiological tests before use.  Specifically,  *** 1
1893 21 CFR 211.165(f) Reprocessed drug products not meeting acceptance criteria Reprocessed drug material or product has not met appropriate [standards] [specifications] [relevant criteria] prior to acceptance and use.  Specifically, *** 1
1939 21 CFR 211.167(c) Controlled release test methods written, followed Test procedures describing the testing of controlled release dosage form drug product are not [written] [followed].  Specifically, *** 1
1956 21 CFR 211.180(e)(1) Representative Number of Batches for Annual Review The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number of  [approved] [rejected] batches.  Specifically, *** 1
1958 21 CFR 211.180(f) Responsible firm officials notified in writing Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions,  are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices].  Specifically, *** 1
1979 21 CFR 211.182 Chronological Order of Equipment Log Entries The entries in the equipment cleaning and use logs are not in chronological order.  Specifically, *** 1
2001 21 CFR 211.184(b) Component Test Records 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, *** 1
2004 21 CFR 211.184(d) Labeling: documentation of exam and review 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, *** 1
2005 21 CFR 211.184(e) Records of disposition of rejected material Records do not include the disposition of rejected [components] [drug product containers] [closures] [labeling].  Specifically, *** 1
2017 21 CFR 211.188(b)(5) In-Process and Laboratory Control Results The batch production and control records are deficient in that they do not  include [in-process] [laboratory] control results.  Specifically, *** 1
2018 21 CFR 211.188(b)(6) Documentation of Packaging and Labeling Area Inspections 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, *** 1
2023 21 CFR 211.188(b)(11) Identification of Persons Performing Significant Steps 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, *** 1
2024 21 CFR 211.188(b)(12) Documentation of Batch Investigations The batch production and control records are deficient in that they do not  include documentation of batch investigations performed.  Specifically, *** 1
2089 21 CFR 211.208 No records maintained No records are maintained for salvaged drug products.  Specifically, *** 1
2397 21 CFR 211.194(a)(1) Description and Identification of Samples 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, *** 1
2402 21 CFR 211.194(a)(5) Testing Calculations Laboratory records are deficient in that they do not include all calculations performed during testing.  Specifically, *** 1
2405 21 CFR 211.194(a)(7) Identification of Person Performing the Testing 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, *** 1
2420 21 CFR 211.198(a) Quality Control Review 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, *** 1
2618 21 CFR 211.198(b)(1) Complaint Record required information Complaint records are deficient in that they do not include the known [name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant].  Specifically, *** 1
2621 21 CFR 211.198(b)(3) Reason for Not Conducting Complaint Investigation Complaint records are deficient in that they do not document the reason and the individual  making the decision not to conduct a complaint investigation.  Specifically, *** 1
3445 21 CFR 211.65(a) Equipment construction - reactive surfaces 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, *** 1
3546 21 CFR 211.46(a) Adequate ventilation not provided Adequate ventilation is not provided.  Specifically, *** 1
3556 21 CFR 211.50 Sewage and refuse disposal in safe manner Disposal of  [sewage] [trash] [refuse] from the [building] [immediate premises] is not done  in a safe and sanitary manner.  Specifically, *** 1
3577 21 CFR 211.101(b)(4) Subdivided component/container/finished drug Containers holding subdivided components for drug product manufacturing are deficiently identified in that they lack the batch for which component was dispensed, including its name, strength, and lot number.  Specifically, *** 1
3598 21 CFR 211.132(b)(1) OTC products requiring tamper-evident packaging OTC products packaged for retail sale which are not specifically excluded from the requirement for tamper-evident packaging are not sold in tamper-evident packages.  Specifically, *** 1
3604 21 CFR 211.160(b)(1) Determination of conformance 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, *** 1
3607 21 CFR 211.160(b)(2) Acceptance of in-process materials Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for in-process materials.  Specifically, *** 1
3624 21 CFR 211.170(a) Reserve sample quantity - active ingredients only The reserve sample of active ingredient does not consist of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications.  Specifically, *** 1
4302 21 CFR 211.56(b) Written sanitation procedures not followed Written procedures for sanitation are not followed.  Specifically, *** 1
4304 21 CFR 211.68(b) Written record not kept of program and validation data 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, *** 1
4311 21 CFR 211.84(c)(4) Compositing of Sub Samples Components which must be sampled from top, middle and bottom of the container are not kept separate, but instead are composited for testing.  Specifically, *** 1
4316 21 CFR 211.84(d)(3) Testing Containers & Closures Conformity with Specs Containers and closures are not tested for conformance with all appropriate written procedures.  Specifically, *** 1
4322 21 CFR 211.101(d) Component release checked by 2nd person 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, *** 1
4323 21 CFR 211.115(a) Reprocessing procedures lack steps to be taken Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics.  Specifically, *** 1
4324 21 CFR 211.110(b) In-process materials specifications testing Examination and testing of samples is not done to assure that in-process materials conform to specifications.  Specifically, *** 1
4325 21 CFR 211.110(a) Control procedures fail to include the following 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,*** 1
4327 21 CFR 211.122(c) Records fail to include Records kept for each different labeling and packaging material shipment fail to include [the receipt] [results of examination or testing] [a statement of whether the shipment was accepted or rejected].  Specifically, *** 1
4328 21 CFR 211.122(a) Written procedures not followed Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed.  Specifically, *** 1
4330 21 CFR 211.130(e) Packaging line inspection documentation Results of inspection of packaging and labeling facilities are not documented in the batch production records.  Specifically, *** 1
4341 21 CFR 211.142(a) Quarantine - written procedures Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit.  Specifically, *** 1
4350 21 CFR 211.160(b)(3) Drug products-sampling procedures/specifications Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products.  Specifically, *** 1
4362 21 CFR 211.170(b)(3) Retention time for exempt OTC drug products You did not retain reserve samples for OTC drug products which were exempt from bearing an expiration date for 3 years after the lots or batches of drug products were distributed.  Specifically, *** 1
4364 21 CFR 211.176 Failing to test for penicillin cross-contamination 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, *** 1
4369 21 CFR 211.188(b)(11) Identification of persons involved, each significant step 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, *** 1
4374 21 CFR 211.188(b)(6) Inspection of packaging and labeling area Batch production and control records do not include results of the inspection of the packaging and labeling area [before] [after] use for each batch of drug product produced.  Specifically, *** 1
4380 21 CFR 211.198(b)(3) Determination not to conduct investigation of complaint 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, ***  1
4383 21 CFR 211.198(b)(1) Written complaint record must include Written complaint records do not include, where known, [the name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant].  Specifically, *** 1
4404 21 CFR 211.194(a)(1) Sample identification and other information 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, ***  1
4415 21 CFR 211.204 Returned drug products with doubt cast as to safety et. al. Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not [destroyed] [subjected to examination, testing or other investigation to prove the drug products do meet all the necessary parameters].  Specifically, *** 1
6731 21 CFR 314.80(c) [NDA prod] Fail to submit report in apprvd electronic format You did not submit adverse drug experience information in electronic format.  Specifically, *** 1
6825 21 CFR 314.80(c)(1)(iii) Non-applicant reports to applicant You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both serious and unexpected.  However, you did not submit each report to the applicant [within five calendar days of your receipt of the information].  Specifically, *** 1
8914 21 CFR 314.81(b)(2)(iv)(b) Mfg and control changes not requiring a supplemental app. An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.   Specifically, *** 1
8923 21 CFR 314.81(b)(2) Form FDA 2252 A [completed] Form FDA 2252 (Transmittal of Periodic Reports for Drugs for Human Use) was not submitted with an annual report.  Specifically, *** 1
8936 FDCA 760(b)(1) No label copy submitted with AE report (non-Rx drug)  Copies of labels from on or within the retail package of a non-prescription drug  did not accompany serious drug event report. Specifically, *** 1
8938 FDCA 760(c)(1) Timing of AE report submission (non-RX drugs) An adverse event report for a nonprescription drug was not submitted to the Secretary of HHS within 15 business days of receipt of the report.  1
8939 FDCA 760(c)(2) New medical information, timing of submission (non-Rx drugs) An adverse event report for a nonprescription drug was not submitted to the Secretary of HHS within 15 business days of receipt of the report. Specifically, *** 1
10019 21 CFR 314.80(c)(1)(iii) Non-applicant reports directly to FDA You, as a non-applicant electing not to submit to the applicant all reports of serious and unexpected adverse drug experiences, failed to submit all reports directly to FDA within 15 calendar days of your receipt of the adverse drug experience information.  Specifically, *** 1
10022 21 CFR 310.305(a) Failure to develop written procedures Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of postmarketing adverse drug experiences. Specifically, *** 1
17757 21 CFR 212.20(b) Examine, approve or reject You did not approve or reject [components] [containers] [closures] [in-process materials] [packaging materials] [labeling] [finished dosage forms] in a manner that ensures compliance with procedures and specifications affecting the identity, strength, quality or purity of a PET drug.  Specifically,*** 1
17764 21 CFR 212.20(e) Written QA procedures established, followed You did not [establish] [follow] written quality assurance procedures. Specifically,*** 1
17777 21 CFR 212.40(c) Designation of incoming lots You did not designate each incoming lot of [components] [containers] [closures] as quarantined, accepted, or rejected.  Specifically,*** 1
17778 21 CFR 212.40(c) Use of reliable suppliers You did not use a reliable supplier as a source of each lot of [component] [container] [closure].  Specifically,*** 1
17851 21 CFR 212.60(c) Analytical methods Your laboratory analytical methods [are not suitable for their intended use] [are not sufficiently sensitive] [are not sufficiently specific] [are not accurate] [are not reproducible].  Specifically,*** 1
17855 21 CFR 212.60(e) Equipment All equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing valid results].  Specifically,*** 1
17875 21 CFR 212.70(b) Compendial test procedure You did not first [verify] [document] that an established compendial test procedure works under the conditions of actual use.  Specifically,*** 1
17941 21 CFR 212.71(b) Documentation of Non-Conforming Product Investigation 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*** 1
17960 21 CFR 361.1(c)(2) Representation of the required fields of expertise The RDRC met without having the appropriate representation of the required fields of expertise.  Specifically, *** 1
17961 21 CFR 361.1(c)(2) RDRC has not kept minutes of its meetings The RDRC did not keep minutes for each of its meetings.  Specifically, *** 1
17964 21 CFR 361.1(c)(2) RDRC did not meet at least once each quarter The RDRC did not meet at least once each quarter in which research activity was authorized or conducted.  Specifically, *** 1
17968 21 CFR 361.1(c)(3) FDA research proposals not reported +30 subjects The RDRC did not [immediately] report to FDA a research proposal that involves exposure of more than thirty (30) subjects.  Specifically, *** 1
17994 21 CFR 361.1(f)(2) Label - For research use The label of a radioactive drug prepared, packaged, distributed, and primarily intended for use in the RDRC research project did not bear a statement that the drug is to be administered in compliance with radioactive drug research use.  Specifically, *** 1
17996 21 CFR 361.1(f)(4) Label - Established name, quantity active ingredient The label of a radioactive drug prepared, packaged, distributed, and primarily intended for use in the RDRC research project did not bear the established name and quantity of each active ingredient. Specifically, *** 1
17997 21 CFR 361.1(f)(5) Label - radioactivity, amount The label of a radioactive drug prepared, packaged, distributed, and primarily intended for use in the RDRC research project did not bear the [name and half-life of the radionuclide] [total quantity of radioactivity in the drug product's immediate container] [amount of radioactivity per unit volume or unit mass at a designated referenced time]. Specifically, *** 1
18001 21 CFR 361.1(f)(9) Label - Name, address manufacturer The label of a radioactive drug prepared, packaged, distributed, and primarily intended for use in the RDRC research project did not bear the [name] [address] of the manufacturer, packer, or distributor.  Specifically, *** 1
18003 21 CFR 361.1(f)(11) Label - Parenteral drug, sterile 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, *** 1
18025 21 CFR 314.80(c)(2)(ii)(B) Late submission of an ICSR 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, *** 1
18033 21 CFR 314.80(g)(1)  Failure to submit electronic format safety report  Not all safety report submissions were made in an electronic format.  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
1560 21 CFR 110.35(c) Lack of effective pest exclusion 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, *** 330
1306 21 CFR 110.20(b)(7) Screening Failure to provide adequate screening or other protection against pests.  Specifically, *** 211
1524 21 CFR 123.11(b) Sanitation monitoring 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, *** 203
1422 21 CFR 110.20(b)(4) Floors, walls and ceilings 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, *** 192
1552 21 CFR 110.35(a) Buildings/sanitary Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.  Specifically, *** 176
905 21 CFR 123.6(b) HACCP plan implementation You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan.  Specifically, *** 162
1554 21 CFR 110.35(a) Cleaning and sanitizing operations 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, *** 157
1695 21 CFR 110.80(b)(2) Manufacturing conditions Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination].  Specifically, *** 156
1689 21 CFR 110.80 Reasonable precautions All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, *** 146
1287 21 CFR 110.20(a)(1) Harborage areas 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, *** 137
990 21 CFR 110.10(b)(3) Not washed/sanitized when appropriate 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, *** 130
1701 21 CFR 110.80(b)(7) Equipment, containers, utensils Failure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold] [store] food in a manner that protects against contamination.  Specifically, *** 127
1405 21 CFR 110.10(b)(6) Failure to wear Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate.  Specifically, *** 124
1553 21 CFR 110.35(a) Buildings/good repair Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated.  Specifically, *** 118
1562 21 CFR 110.35(d) Failure to clean - general Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food.  Specifically, *** 118
960 21 CFR 123.6(c)(2) Critical control points Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.  Specifically, *** 117
18254 21 CFR 1.502(a) Develop FSVP You did not develop an FSVP.  Specifically, *** 108
961 21 CFR 123.6(c)(3) Critical limits 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, 106
945 21 CFR 123.12(a)(2) Importer verification 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, *** 104
1427 21 CFR 110.20(b)(5) Safety lighting and glass Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food.  Specifically, *** 102
959 21 CFR 123.6(c)(1) Food safety hazards Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.  Specifically, *** 99
1292 21 CFR 110.20(b)(1) Sufficient space 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, *** 93
1125 21 CFR 110.40(a) Materials and workmanship The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance].  Specifically, *** 92
6004 21 CFR 123.6(c)(4) Monitoring - adequacy Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit.  Specifically*** 92
15839 21 CFR 111.70(e)  Specifications - identity, purity, strength, composition  You did not establish product specifications for the [identity] [purity] [strength] [composition] of the finished dietary supplement.  Specifically, *** 92
2386 21 CFR 110.80(a)(1) Storage Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration].  Specifically, *** 88
2392 21 CFR 110.80(b)(1) Maintenance of equip., utensils, and finished food packaging Failure to maintain [equipment] [utensils] [finished food containers] in an acceptable condition through appropriate cleaning and sanitizing.  Specifically, *** 87
1581 21 CFR 110.37(e) Running water at suitable temperature Hand-washing facilities lack running water of a suitable temperature.  Specifically, *** 86
1424 21 CFR 110.20(b)(4) Drip and condensate The plant is not constructed in such a manner as to prevent [drip] [condensate] from contaminating [food] [food-contact surfaces] [food-packaging materials]. Specifically, *** 84
1597 21 CFR 110.37(b)(3) As source of contamination Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils].  Specifically, *** 84
904 21 CFR 123.6(b) No HACCP plan You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.  Specifically, *** 82
963 21 CFR 123.6(c)(5) Corrective action plan 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*** 81
1005 21 CFR 110.10(b)(7) Storage of personal items Personal [clothing] [belongings] were stored  in an area where [food is exposed] [equipment or utensils are washed].  Specifically, *** 76
1556 21 CFR 110.35(b)(2) Storage requirements 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, *** 76
1066 21 CFR 110.40(b) Seams on food contact surfaces 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, *** 75
908 21 CFR 123.6(d) Signed and dated Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually].  Specifically, *** 74
15927 21 CFR 111.103 Written procedures - quality control operations You did not [establish] [follow] written procedures for quality control operations.  Specifically, *** 73
1007 21 CFR 110.10(b)(9) Precautions against contamination--micro, foreign substances Failure to take necessary precautions to protect against contamination of [food] [food contact surfaces] [food packaging systems] with [microorganisms] [foreign substances].  Specifically, *** 66
6005 21 CFR 123.6(c)(6) Verification procedures - adequacy 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, *** 63
6008 21 CFR 123.8(a)(3) Verification - record review - frequency 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, *** 63
15797 21 CFR 111.553 Written procedures - product complaint  You did not [establish] [follow] written procedures for the requirements to review and investigate a product complaint.  Specifically, *** 63
15869 21 CFR 111.75(c) Specifications met - verify; finished batch  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, *** 61
4470 21 CFR 108.25(c)(2) Process filing Failure to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container size. Specifically, *** 60
3658 21 CFR 110.37(e)(2) Hand cleaning and sanitizing preparations Lack of effective hand [cleaning] [sanitizing] preparations.  Specifically, *** 59
1006 21 CFR 110.10(b)(8) Personal food/drink/tobacco 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, *** 58
1406 21 CFR 110.10(b)(6) Effective use of hair restraint Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner.  Specifically, *** 58
3643 21 CFR 110.10(b)(5) Glove condition Gloves used in food handling are not maintained in an intact, clean, and sanitary condition.  Specifically, *** 58
1525 21 CFR 123.11(c) Sanitation Records 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, *** 57
1702 21 CFR 110.80(b)(8) Metal / extraneous materials Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food.  Specifically, *** 56
3652 21 CFR 110.37(e)(1) Suitable locations Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed.  Specifically, *** 56
1402 21 CFR 110.10(b)(4) Unsecured jewelry Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers].  Specifically, *** 55
18149 21 CFR 117.40

Equipment and Utensils - Design and Maintenance Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against [allergen cross-contact] [contamination].  Specifically, *** 54
18161 21 CFR 117.80(c)

Manufacturing, Processing, Packing, Holding - Controls 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, *** 53
15762 21 CFR 111.205(a) Master manufacturing record - each batch  You did not [prepare] [follow] a written master manufacturing record for each batch size of a dietary supplement that you manufactured.  Specifically, *** 50
15861 21 CFR 111.75(a)(2)(ii)(A)   Component - qualify supplier  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, *** 50
1615 21 CFR 110.93 Storage/transportation of finished goods (contamination) Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination.  Specifically, *** 49
1698 21 CFR 110.80(b)(5) Work-in-progress Failure to handle work-in-progress in a manner that protects against contamination.  Specifically, *** 48
18141 21 CFR 117.35(a) Sanitary Operations - Plant Maintenance You did not [maintain your plant in a clean and sanitary condition] [keep your plant in repair].  Specifically, *** 48
985 21 CFR 110.10(b)(1) Suitable outer garments Suitable outer garments are not worn  that protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, *** 47
1173 21 CFR 110.40(f) Q.C. instrument accuracy, maintenance Instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms are not [accurate] [adequately maintained].  Specifically,*** 47
15532 21 CFR 111.255(b)   Batch record - complete Your batch production record did not include complete information relating to the production and control of each batch.  Specifically, *** 47
15641 21 CFR 111.453  Written procedures - holding  You did not [establish] [follow written] procedures for holding and distributing operations.  Specifically, *** 46
18138 21 CFR 117.10 Personnel You did not take a reasonable measure and precaution related to personnel practices.  Specifically, *** 46
3659 21 CFR 110.37(e)(3) Hand drying Lack of a sanitary towel service or suitable hand drying devices.  Specifically, *** 45
3661 21 CFR 110.37(e)(5) Signs Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate.  Specifically, *** 45
15858 21 CFR 111.75(a)(1)(i) Component -  verify identity, dietary ingredient  You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.  Specifically, *** 45
15830 21 CFR 111.70(b)(2) Specifications-component purity, strength, composition  You did not establish component specifications for [purity] [strength] [composition].  Specifically, *** 44
6021 21 CFR 123.10 HACCP training or qualification No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.  Specifically, *** 43
1429 21 CFR 110.20(b)(6) Fans/air blowing equipment Failure to [locate] [operate] fans and other air-blowing equipment in a manner that minimizes the potential for contaminating [food] [food-contact surfaces] [food-packaging materials].  Specifically, *** 41
9931 21 CFR 120.6(b) Sanitation monitoring 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, ***  41
6018 21 CFR 123.7(a) Corrective action per predetermined plan You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected].  Specifically,*** 40
16042 21 CFR 111.503 Written procedures - returned dietary supplement  You did not [establish] [follow] written procedures for when a returned dietary supplement is received.  Specifically, *** 40
3071 21 CFR 114.80(a)(1) Scheduled process Acidified food is not manufactured in accordance with the scheduled process.  Specifically, *** 39
6020 21 CFR 123.9(a) Records - content 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, *** 39
15825 21 CFR 111.65 Quality control - quality, dietary supplement  You did not implement quality control operations to ensure the quality of the dietary supplement.  Specifically,  *** 38
15897 21 CFR 111.83(a) Reserve sample - collect, hold  You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.  Specifically, *** 38
3086 21 CFR 114.100(b) Maintenance of processing and production records Failure to maintain [processing] [production] records showing adherence to the scheduled processes, including records of [pH measurement] [critical factors] intended to ensure a safe product.  Specifically, *** 36
15659 21 CFR 111.475(b)(1) Written procedures - holding; distributing  You did not make and keep written procedures for holding and distributing operations.  Specifically, *** 36
933 21 CFR 123.8(a)(2)(ii) Calibration - adequacy Your process monitoring equipment is not calibrated to ensure that it reads accurately.  Specifically, *** 34
3078 21 CFR 114.80(b) Code - required elements 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, *** 34
1126 21 CFR 110.40(a) Precluding contaminants The [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food with [lubricants] [fuel] [metal fragments] [contaminated water] [contaminants].  Specifically, *** 33
15829 21 CFR 111.70(b)(1) Specifications - component identity  You did not establish an identity specification for each component.  Specifically, *** 33
18140 21 CFR 117.20(b) Plant Construction and Design Your plant was not [constructed] [designed] to facilitate maintenance and sanitary operations.  Specifically, *** 32
1565 21 CFR 110.35(d)(3) Non-food-contact surfaces (S) Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination.  Specifically, *** 31
1571 21 CFR 110.35(d)(5) Shown to be effective The [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not been shown to provide adequate [cleaning] [sanitizing treatment].  Specifically, *** 31
1763 21 CFR 110.35(b)(1) Safe and adequate for use Use of cleaning compounds and sanitizing agents which are not [free from undesirable microorganisms] [safe and adequate under the conditions of use].  Specifically, *** 31
1293 21 CFR 110.20(b)(2) Contamination with microorganisms, chemicals, filth, etc. 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, *** 30
6001 21 CFR 123.11(b) Sanitation monitoring documentation Your sanitation control records do not accurately document the conditions or practices observed at your firm.  Specifically***



29
18148 21 CFR 117.37

Sanitary Facilities and Control Your plant did not have adequate sanitary facilities and accommodations.  Specifically, *** 29
3080 21 CFR 114.83 Scheduled process establishment 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, *** 28
15531 21 CFR 111.255(a) Batch record - every batch You did not prepare a batch production record every time you manufactured a batch of dietary supplement.  Specifically, *** 28
15809 21 CFR 111.570(b)(1)   Written procedures - product complaint; review, investigate  You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint.  Specifically, *** 28
1067 21 CFR 110.40(c) Non food-contact equipment in processing area Non food-contact equipment in [manufacturing] [food handling] areas is not constructed so that it can be kept in a clean condition.  Specifically, *** 27
1570 21 CFR 110.35(d)(5) Safe and adequate for use Sanitizing agents are [inadequate] [unsafe] under conditions of use.  Specifically, *** 27
1599 21 CFR 110.37(b)(5) Backflow prevention Lack of backflow protection from piping systems that discharge [waste water] [sewage].  Specifically, *** 27
901 21 CFR 123.6(a) Hazard analysis 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, *** 26
1426 21 CFR 110.20(b)(5) Adequate lighting 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, *** 26
4464 21 CFR 108.25(c)(1) Registration Failure to register with the FDA information including the name, principal place of business and the location of the processing establishment within 10 days after engaging in the manufacture, processing and packaging of acidified foods. Specifically, *** 26
18142 21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation You did not clean and sanitize your utensils or equipment in a manner that protects against [allergen cross-contact] [contamination].  Specifically, *** 26
1596 21 CFR 110.37(b)(2) Convey sewage Plumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey sewage and liquid disposable waste from the plant.  Specifically, *** 25
3656 21 CFR 110.37(d)(3) Self-closing doors Toilet facilities lack self-closing doors.  Specifically, *** 25
18145 21 CFR 117.35(c)

Pest Control You did not [exclude pests from your food plant] [use pesticides under precautions and restrictions] to protect against contamination of food.  Specifically, ***  25
1184 21 CFR 110.35(e) Storage of cleaned portable equipment (S) Failure to store cleaned and sanitized portable equipment in a [location] [manner] which protects food-contact surfaces from contamination.  Specifically, *** 24
1709 21 CFR 110.80(b)(13) Filling, assembling, packing controls Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated.  Specifically, *** 24
3654 21 CFR 110.37(d)(1) Maintained Failure to maintain toilet facilities in a sanitary condition.  Specifically, *** 24
4479 21 CFR 108.25(e) Recall procedures Failure to prepare and maintain in files current procedures for [recalling products that may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining the effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically, *** 24
15763 21 CFR 111.205(a)  Master manufacturing record - unique formulation  You did not [prepare] [follow] a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured.  Specifically, *** 24
16057 21 CFR 111.535(b)(1) Records - returned dietary supplement: written procedures  You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements.  Specifically, *** 23
1403 21 CFR 110.10(b)(4) Hand jewelry - remove/cover Failure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods where food is being manipulated by hand.  Specifically, *** 22
6015 21 CFR 123.6(c)(6) Verification procedures - none/frequency  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, *** 22
906 21 CFR 123.6(b) HACCP plan location Your HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery product processed].  Specifically, *** 21
1561 21 CFR 110.35(c) Insecticides/rodenticides Use of [insecticides] [rodenticides] without observing necessary precautions and restrictions to protect against contamination of [food] [food-contact surfaces] [food-packaging materials].  Specifically, *** 21
1598 21 CFR 110.37(b)(4) Drainage Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage.  Specifically, *** 21
3647 21 CFR 110.10(c) Training of handlers and supervisors Appropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors].  Specifically, *** 21
6010 21 CFR 123.8(a)(3)(i) Monitoring record review adequacy 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, *** 21
1578 21 CFR 110.37(f) Odor, attractant for pests, harborage 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, *** 20
1130 21 CFR 110.40(a) Food-contact - withstand food & cleaning cmpds. 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, *** 19
1696 21 CFR 110.80(b)(3) Holding foods - refrigerate/freeze/heat Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated.  Specifically, *** 19
3073 21 CFR 114.80(a)(2) pH testing Failure to exercise sufficient control including [frequent testing] [recording of results] so that the finished equilibrium pH values are not higher than 4.6.  Specifically, *** 19
3085 21 CFR 114.100(a) Raw materials, packaging, finished product 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, *** 19
3877 21 CFR 113.60(c) Coding - required elements 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, *** 19
6007 21 CFR 123.9(a) Records entries - timing Processing or other information was not [always] entered on your records at the time it was observed.  Specifically, *** 19
6019 21 CFR 123.8(a)(2) Ongoing verification - complaints, calibration records 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, *** 19
12742 21 CFR 120.8(a) HACCP plan not implemented You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan.  Specifically, *** 19
15838 21 CFR 111.70(d) Specifications - labels, packaging  You did not establish [label] [packaging] specifications.  Specifically, ***

19
18165 21 CFR 117.93

Storage and Transportation You did not store or transport food, including ingredients, under conditions that protect against [allergen cross-contact] [contamination] [deterioration] [adulteration].  Specifically, *** 19
918 21 CFR 123.8(a) Verification - reviewers qualifications 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, *** 18
3062 21 CFR 114.10 Personnel 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, *** 18
3067 21 CFR 114.80(a) Quality control procedures Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard.  Specifically, "*** 18
15819 21 CFR 111.55 Production, process controls - implement  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, *** 18
18146 21 CFR 117.35(d)

Sanitation of food contact surfaces - frequency You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against [allergen cross-contact] [contamination of food].  Specifically, *** 18
2361 21 CFR 110.80 Testing Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, *** 17
15831 21 CFR 111.70(b)(3) Specifications - contamination limits  You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.  Specifically, *** 17
913 21 CFR 123.8(a)(1) Reassessment of HACCP plan 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, *** 16
2393 21 CFR 110.80(b)(1) Teardown equipment/thorough cleaning Failure to take apart equipment as necessary to ensure thorough cleaning.  Specifically, *** 16
4475 21 CFR 108.25(c)(3)(i) Process adherence Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, *** 16
15828 21 CFR 111.70(a)  Specifications - manufacturing process  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, *** 16
4511 21 CFR 108.25(f) Approved school Failure to have personnel involved in [acidification] [pH control] [heat treatment] [critical factors] under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, *** 15
6006 21 CFR 123.6(c)(7) Records values/observations Your monitoring records do not contain the actual values and observations obtained during monitoring.  Specifically, *** 15
18153 21 CFR 117.80(a)

Plant Operations - precautions 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, *** 15
986 21 CFR 110.10(b)(2) Personal cleanliness Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness.  Specifically, *** 14
1128 21 CFR 110.40(a) Installation and maintenance of equipment (S) Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces].  Specifically, *** 14
1132 21 CFR 110.40(a) Food-contact - unlawful indirect additives Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.  Specifically, *** 14
1172 21 CFR 110.40(e) Lack of thermometer Lack of an accurate indicating thermometer, temperature measuring device, or temperature recording device in each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms.  Specifically, *** 14
2388 21 CFR 110.80(a)(5) Holding in bulk or suitable containers Failure to hold [raw materials] [rework materials] [ingredients] in bulk or in suitable containers so as to protect against contamination.  Specifically, *** 14
9955 21 CFR 120.11(a)(1) Verification activities - minimum 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, *** 14
15453 21 CFR 111.16 Written procedures - cleaning You did not [establish] [follow] written procedures for cleaning the physical plant.  Specifically, *** 14
931 21 CFR 123.8(d) Verification - recordkeeping You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, *** 13
932 21 CFR 123.7(d) Corrective action documentation You do not have records that document corrective actions that were taken.  Specifically, *** 13
1129 21 CFR 110.40(a) Food-contact - corrosion resistant Lack of corrosion-resistant food contact surfaces.  Specifically, *** 13
1289 21 CFR 110.20(a)(3) Drainage Lack of adequate drainage of areas which may contribute to contamination of food by [seepage] [foot-borne filth] [providing a breeding place for pests]. Specifically, *** 13
4515 21 CFR 108.35(c)(2) Process filing Failure to provide FDA, before packing any new product, information as to the scheduled process for each low-acid canned food in each container.  Specifically, *** 13
6016 21 CFR 123.6(c)(7) Records system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points.  Specifically, *** 13
18262 21 CFR 1.504(a)

Hazard analysis written 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, *** 13
2384 21 CFR 110.80(a)(7) Receipt/storage - liquid and dry raw materials Failure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against contamination.  Specifically, *** 12
3712 21 CFR 110.93 Storage/transportation of finished goods (deterioration) Failure to [store] [transport] finished food under conditions that would protect against deterioration of the food and its container.  Specifically, *** 12
9930 21 CFR 120.6(c) SSOP records 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, *** 12
12746 21 CFR 120.8(b)(2) HACCP plan - critical control points not listed Your HACCP plan does not list the critical control points for each of the identified food hazards.  Specifically, *** 12
12747 21 CFR 120.8(b)(3) HACCP plan - critical limits not listed or not adequate 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, *** 12
15494 21 CFR 111.25(c) Procedures - equipment - cleaning, sanitizing 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, *** 12
15790 21 CFR 111.403  Written procedures - labeling operations  You did not [establish] [follow] written procedures for labeling operations.  Specifically, *** 12
15840 21 CFR 111.70(e) Specifications -  contamination limits  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, *** 12
16013 21 CFR 111.140(b)(1)   Records - quality control operations; responsibilities You did not make and keep written procedures for the responsibilities of the quality control operations.  Specifically, *** 12
18147 21 CFR 117.35(e)

Sanitation of non-food contact surfaces - frequency 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, *** 12
1090 21 CFR 110.40(d) Holding, conveying, mfg systems - design & construction Lack of appropriate [design] [construction] to enable [holding] [conveying] [manufacturing] systems to be maintained in an appropriate sanitary condition.  Specifically, *** 11
1566 21 CFR 110.35(d)(4) Single-service articles Failure to [store] [handle] [dispense] [use] [dispose of] single-service articles in a manner that protects against the contamination of food and food-contact surfaces.  Specifically, *** 11
2385 21 CFR 110.80(a)(1) Inspection, segregation, handling of raw materials Failure to [inspect] [segregate] [handle] raw materials to ascertain that they are clean and suitable for processing into food.  Specifically, *** 11
3090 21 CFR 114.100(d) Product distribution Records identifying initial distribution of finished product are not maintained.  Specifically, *** 11
3657 21 CFR 110.37(d)(4) Doors opening into processing areas Toilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such contamination.  Specifically, *** 11
4519 21 CFR 108.35(c)(3)(i) Process adherence Failure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, *** 11
6002 21 CFR 123.11(b) Sanitation corrections You did not correct sanitation deficiencies in a timely manner.  Specifically,*** 11
9941 21 CFR 120.8(a) No HACCP plan 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, *** 11
15410 21 CFR 111.14(b)(2) Personnel - records - training You did not make and keep documentation of training.  Specifically, *** 11
15702 21 CFR 111.320(b)  Examination, testing; scientifically valid 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, *** 11
16089 FDCA 417(d)(1)(A) Reportable food report - submission You did not submit a reportable food report to FDA within 24 hours after you determined that a food was a reportable food.  Specifically, *** 11
16118 21 CFR 118.4 Written SE plan not implemented/followed Your written SE prevention plan is not [fully] implemented and followed. Specifically,*** 11
19058 21 CFR 117.135(c)(3) Sanitation Controls Procedures Your sanitation controls procedures did not ensure [cleanliness of food-contact surfaces] [prevention of allergen cross-contact] [prevention of cross-contamination].  Specifically, *** 11
2394 21 CFR 110.80(b)(6) Contamination by raw materials, refuse, other ingredients Failure to take effective measures to protect finished food from contamination by [raw materials] [refuse] [other ingredients] .  Specifically, *** 10
3088 21 CFR 114.100(b) Processing and production - required information 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, *** 10
3653 21 CFR 110.37(d) Readily accessible Failure to provide employees with [readily accessible] [adequate] toilet facilities.  Specifically, *** 10
6022 21 CFR 123.12(c) Lack of records 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, *** 10
9954 21 CFR 120.11(a)(1)(iv) Verification - CCP, CA record review 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, *** 10
12745 21 CFR 120.8(b)(1) HACCP plan - food hazards not listed Your HACCP plan does not list all food hazards that are reasonably likely to occur.  Specifically, *** 10
15747 21 CFR 111.210(g)  Packaging description, representative label  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,  10
15871 21 CFR 111.75(c)(2) Specifications met - test, examinations; compliance  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, *** 10
15885 21 CFR 111.77(a) Specifications not met - reject, quality control  Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] for which a specification was not met.  Specifically, *** 10
15932 21 CFR 111.105(a)   Processes, specifications, written procedures 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, *** 10
19030 21 CFR 117.130(a)(1) Hazard Analysis - Identification of Hazard Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control.  Specifically, *** 10
1568 21 CFR 110.35(d)(2) Before use and after interruption Failure to clean and sanitize food-contact surfaces in wet-processing [before use] [after any interruption during which they may have been contaminated], to preclude contamination with microorganisms.  Specifically, *** 9
1766 21 CFR 110.35(b)(1) Unacceptable toxic compounds Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are unnecessary for use in plant operations.  Specifically, *** 9
3093 21 CFR 114.89 Process deviation evaluation - record  Failure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations].  Specifically, *** 9
3650 21 CFR 110.35(d)(1) Wet cleaning Failure to sanitize and thoroughly dry, prior to use,  food-contact surfaces which have been wet cleaned.  Specifically, *** 9
9958 21 CFR 120.12(c) Records - signed/dated 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, *** 9
12743 21 CFR 120.8(b)(4) HACCP plan - monitoring procedures not adequate Your HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure compliance with the critical limits.  Specifically, *** 9
12755 21 CFR 120.11(a)(1)(iv)  Records - not signed and dated by qualified individual 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, ***

9
15425 21 CFR 111.15(i) Hand-washing facilities Your hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a suitable temperature].  Specifically, ***  9
15434 21 CFR 111.15(d)(2) Pest control measures 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, *** 9
15454 21 CFR 111.16 Written procedures - pest control You did not [establish] [follow] written procedures for pest control.  Specifically, *** 9
15642 21 CFR 111.455(a) Hold - temperature, humidity, light  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, *** 9
15737 21 CFR 111.210(h)(5) Corrective action plans The written instructions in your master manufacturing record did not include instructions for corrective action plans to use when specifications are not met.  Specifically, *** 9
15744 21 CFR 111.210(h)(2)   Master manufacturing record - sampling, tests, examinations  The written instructions in your master manufacturing record did not include [procedures for sampling] [a cross-reference to procedures for tests or examinations]. Specifically, *** 9
15761 21 CFR 111.205(b)(1) Master manufacturing record - specifications; quality  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, *** 9
15862 21 CFR 111.75(a)(2) Appropriate tests, examinations; certificate of analysis You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications.  Specifically, *** 9
15930 21 CFR 111.105 Ensure quality; package, labeled, master record Your quality control personnel did not ensure that your [manufacturing] [packaging] [labeling] [holding] operations ensure the quality of the dietary supplement.  Specifically, *** 9
18139 21 CFR 117.20(a) Grounds You did not keep the grounds around your plant in a condition that would protect against the contamination of food.  Specifically, ***  9
18143 21 CFR 117.35(b)(1)

Cleaning and sanitizing substances- safe and adequate You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the conditions of use.  Specifically, *** 9
1196 21 CFR 110.10(a) Employees with illness,  lesions, contamination source Employees  who appear to have an [illness] [open lesion] [abnormal source of microbial contamination] are not excluded from operations where there is a reasonable possibility of [food] [food contact surfaces] [food packaging materials] becoming contaminated.  Specifically, *** 8
1425 21 CFR 110.20(b)(4) Spacing of equipment Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width].  Specifically, *** 8
1577 21 CFR 110.37(f) Contamination of food, contact surfaces, water supplies, etc The [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of [food] [food-contact surfaces] [water supplies] [ground surfaces].  Specifically, *** 8
1601 21 CFR 110.37(a) Safe and adequate sanitary quality Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces.  Specifically, *** 8
3075 21 CFR 114.80(a)(4) Container testing Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination.  Specifically, *** 8
9939 21 CFR 120.7(c) All hazards not considered 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, *** 8
12748 21 CFR 120.8(b)(5) HACCP plan - corrective action plan not included  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,*** 8
15481 21 CFR 111.23(b) Records - cleaning, pest control You did not make and keep records of the written procedures for [cleaning the physical plant] [pest control].  Specifically, *** 8
15492 21 CFR 111.25(a) Procedures - calibrating instruments 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, *** 8
15496 21 CFR 111.27(b) Instruments - calibration 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, *** 8
15543 21 CFR 111.260(c)  Batch record - date, time; maintenance 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, *** 8
15546 21 CFR 111.260(f)  Batch record - yield 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, *** 8
15645 21 CFR 111.455(c) Hold - mix-up, contamination, deterioration  You held [components] [dietary supplements] [packaging] [labels] under conditions that  lead to mix-up, contamination, or deterioration. Specifically, *** 8
15660 21 CFR 111.475(b)(2)  Records - product distribution  You did not make and keep records of product distribution.  Specifically, *** 8
15863 21 CFR 111.75(a)(2)(ii)(B) Component - certificate of analysis  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, *** 8
15963 21 CFR 111.113(b)(2)   Quality control - reject; specification not met Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] when an established specification was not met.  Specifically, *** 8
16014 21 CFR 111.140(b)(1)   QC ops; written procedures; material review, disposition 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, *** 8
16120 21 CFR 118.4 Written SE plan lacks required elements Your written SE prevention plan lacks appropriate SE prevention measures.  Specifically,*** 8
16135 21 CFR 118.4(b)(4) Stray animals Stray animals are not prevented from entering poultry houses.  Specifically,*** 8
18293 21 CFR 1.506(b) Supplier verification - establish written procedures 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, *** 8
19059 21 CFR 117.145(a) Sanitation Controls Monitoring Proced: Establish Implement You did not [establish] [implement] adequate written procedures for monitoring sanitation controls.  Specifically, *** 8
950 21 CFR 123.12(d) Determination of compliance 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, *** 7
1316 21 CFR 113.87(c) Initial temperature of container contents 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, *** 7
1330 21 CFR 113.100(a) Process records - forms missing information 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, *** 7
1472 21 CFR 113.83 Critical factors not stated A critical factor that may affect the scheduled process was not specified in the scheduled process.  Specifically, *** 7
1602 21 CFR 110.37(a) Suitable temp. and pressure 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, *** 7
1711 21 CFR 110.80(b)(15) Proper pH controls 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, *** 7
2101 21 CFR 113.40(a)(13) Measured, recorded 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, *** 7
2396 21 CFR 110.80(b)(6) Conveyor transportation Failure to take effective measures to protect food transported by conveyor from contamination.  Specifically, *** 7
3645 21 CFR 110.10(d) Supervision Responsibility for assuring compliance with current good manufacturing practices relating to personnel  has not been assigned to competent supervisory personnel.  Specifically, *** 7
3655 21 CFR 110.37(d)(2) Good repair Failure to keep toilet facilities in good repair.  Specifically, *** 7
3662 21 CFR 110.37(e)(6) Refuse receptacles Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food.  Specifically, *** 7
4181 21 CFR 113.89 Process deviation identification Failure to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control.  Specifically, *** 7
6014 21 CFR 123.6(c)(2) Monitoring - none 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, 7
12734 21 CFR 120.12(a) Records required - not maintained 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, *** 7
12749 21 CFR 120.8(b)(6) HACCP plan - verify procedures / frequency - none listed Your HACCP plan does not list the verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is being implemented.  Specifically, *** 7
15401 21 CFR 111.12(b) Personnel - quality control operations You have not identified personnel to be responsible for your quality control operations.  Specifically, *** 7
15404 21 CFR 111.12(c) Personnel - education, training, experience 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, *** 7
15652 21 CFR 111.465(b) Retain reserve samples - 1 year, 2 years  You did not retain reserve samples for the required time.  Specifically, *** 7
15748 21 CFR 111.210(f) Master manufacturing record theoretical and expected yield 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, *** 7
15853 21 CFR 111.73 Specifications met - identity, purity, strength, composition You did not determine whether you met established product specifications for [identity] [purity] [strength] [composition of the finished batch of the dietary supplement].  Specifically, *** 7
15872 21 CFR 111.75(c)(3) Specifications met identity,purity, strength, comp,; basis  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, *** 7
15933 21 CFR 111.105(b)   Quality control - supplier qualification Your quality control personnel did not review and approve the documentation setting forth the basis for qualification of suppliers.  Specifically, *** 7
16040 21 CFR 111.610(a) Records - available; FDA  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, *** 7
16494 FDCA 601(c) Insanitary conditions; contaminated with filth Your cosmetic was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth.  Specifically, *** 7
18144 21 CFR 117.35(b)(2)

Toxic Chemicals - identified, held, stored You did not [identify] [hold] [store] a toxic chemical in a manner that protects against contamination.  Specifically, *** 7
18151 21 CFR 117.40(f) Instruments and Controls Your instruments and controls were not [accurate] [precise] [adequately maintained] [adequate in number].  Specifically, *** 7
18163 21 CFR 117.80(c)(8)

Process Control - Foreign Objects You did not take an adequate measure to protect against inclusion of metal or extraneous material in food.  Specifically, *** 7
18283 21 CFR 1.505(b)

Supplier approval - document You did not document your approval of your foreign supplier.  Specifically, *** 7
19066 21 CFR 117.165(b) Sanitation Controls Verif Procedures: Establish Implement You did not [establish] [implement] adequate written sanitation controls verification procedures for [product testing] [environmental monitoring].  Specifically, *** 7
1642 21 CFR 113.100(b) Review not signed/dated A [processing] [production] record was not [signed or initialed] [dated] by the reviewer.  Specifically, *** 6
3082 21 CFR 114.89 Process deviation Failure to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which [deviated from a scheduled process] [had an equilibrium pH of the finished product higher than 4.6].  Specifically, *** 6
3644 21 CFR 110.10(b)(5) Impermeable (S) Gloves used for food handling are not impermeable.  Specifically,  *** 6
3874 21 CFR 113.60(b) Cooling water - not chlorinated, sanitized Container cooling water was not chlorinated or otherwise sanitized [for cooling canals] [for recirculated water supplies].  Specifically, *** 6
4514 21 CFR 108.35(c)(1) Registration Failure to register with the FDA information including the name, principal place of business and the location of the processing establishment within 10 days after engaging in the manufacture, processing and packaging of low-acid canned foods. Specifically, *** 6
4523 21 CFR 108.35(f) Recall procedures Failure to prepare and maintain in files current procedures for [recalling products which may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically, *** 6
4524 21 CFR 108.35(g) Approved school Failure to have personnel involved in [retorts] [thermal processing systems] [aseptic processing and packaging systems] [thermal processing systems] [container closure inspections] under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, *** 6
9932 21 CFR 120.6(a) Sanitation SSOP - none or not implemented 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, *** 6
9935 21 CFR 120.7(a) No hazard analysis 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, *** 

.  Specifically, ***
6
9947 21 CFR 120.11(b) HACCP plan - not validated 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, *** 6
9961 21 CFR 120.24(a) Process controls - HACCP plan - 5 log reduction 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, *** 6
9986 21 CFR 120.24(c) Process controls - not exempt, single facility 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, *** 6
15480 21 CFR 111.20(h) Physical plant - screening against pests Your physical plant did not use adequate screening or other protection against pests.  Specifically, *** 6
15498 21 CFR 111.27(d) Equipment - maintain, clean, sanitize You did not [maintain] [clean] [sanitize] equipment and utensils used to manufacture, package, label, or hold components or dietary supplements.  Specifically, *** 6
15526 21 CFR 111.30(c) Equipment - automated - calibrate, inspect You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to ensure proper performance.  Specifically, *** 6
15732 21 CFR 111.365(a) Conditions, controls -protect; microorganisms, contamination You did not perform manufacturing operations under conditions and controls that protect against [the potential for growth of microorganisms] [the potential for contamination].  Specifically, *** 6
15736 21 CFR 111.353   Manufacturing operations - written procedures  You  did not [establish] [follow] written procedures for manufacturing operations.  Specifically, *** 6
15841 21 CFR 111.70(f) Specifications - product received for packaging, labeling  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,  6
15893 21 CFR 111.80(c) Specifications - representative samples; finished batch  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, *** 6
15920 21 CFR 111.95(b)(1) Records - established specifications  You did not make and keep records of established specifications.  Specifically, *** 6
15978 21 CFR 111.123(a)(2)   Quality control operations - batch production records Your quality control operations did not include reviewing and approving all batch production-related records.  Specifically, *** 6
16058 21 CFR 111.535(b)(2) Records - ret'nd dietary supplement: material review, dispos You did not make and keep records of a material review and disposition decision on a returned dietary supplement. Specifically, *** 6
18398 21 CFR 117.4

Training of employees and records You did not [train employees in the principles of food hygiene and food safety] [have records documenting training of qualified individuals].  Specifically, *** 6
929 21 CFR 123.8(b) Verification - corrective action 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, *** 5
1428 21 CFR 110.20(b)(6) Adequate ventilation Failure to provide [adequate ventilation] [control equipment] to minimize odors and vapors in areas where they may contaminate food.  Specifically, *** 5
1697 21 CFR 110.80(b)(4) Preventive control measures 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, *** 5
3660 21 CFR 110.37(e)(4) Devices and fixtures Devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands.  Specifically, *** 5
4296 21 CFR 110.80(a)(5) Temperature and humidity Failure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming adulterated.  Specifically, *** 5
4476 21 CFR 108.25(c)(3)(ii) Process information availability Failure to provide the FDA, after written request, any process and procedure information deemed necessary to determine the adequacy of the process. Specifically, *** 5
9928 21 CFR 120.12(b) Records - general - include name, date, time 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, *** 5
12750 21 CFR 120.8(b)(6) HACCP plan - valid procedures / frequency - none listed 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, *** 5
15391 21 CFR 111.10(b)(3) Hand washing 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, *** 5
15402 21 CFR 111.12 Personnel - quality control personnel - qualified 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, *** 5
15499 21 CFR 111.27(a) Equipment - design - suitable 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, *** 5
15534 21 CFR 111.255(c)   Batch record - each step You did not perform each step in the production of a batch, according to the master production record.  Specifically, ***

5
15544 21 CFR 111.260(d) Batch record - component; unique identifier 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, *** 5
15545 21 CFR 111.260(e) Batch record - component; identity, weight Your batch production records did not include the [identity] [weight or measure] of each component used.  Specifically, *** 5
15578 21 CFR 111.155(c) Components - quarantine You did not quarantine components before you used them in the manufacture of a dietary supplement.  Specifically, *** 5
15745 21 CFR 111.210(h)(1) Instructions; specifications; packaged, labeled 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,  *** 5
15746 21 CFR 111.210(h)(1)   Instructions; specifications; quality 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, *** 5
15786 21 CFR 111.410(b) Labels - issuance, use  You did not control the [issuance] [use] of labels, Specifically, *** 5
15817 21 CFR 111.570(b)(2)(ii)(F) Record - product complaint; findings  The written record of a product complaint did not include the [findings of the investigation] [follow-up action taken].  Specifically, *** 5
15843 21 CFR 111.70(g) Specifications - finished packaging, labeling  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, *** 5
15921 21 CFR 111.95(b)(2) Documentation - supplier qualification  You did not make and keep documentation of your qualification of a supplier.  Specifically,  *** 5
15954 21 CFR 111.113(a)(2)   QC master manufacturing record; material review, disposition 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, *** 5
16043 21 CFR 111.503  Written procedures - returned dietary supplement; destroyed  You did not [establish] [follow] written procedures for when a returned dietary supplement must be destroyed, or otherwise suitably disposed.  Specifically, *** 5
16047 21 CFR 111.510 Returned dietary supplement - material review, disposition  You did not identify and quarantine returned dietary supplements until quality control personnel conducted a material review and made a disposition decision.  Specifically, ***  5
18154 21 CFR 117.80(a)(2)

Appropriate quality control operations 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, *** 5
18263 21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical Your hazard analysis did not include a known or reasonably foreseeable [biological] [chemical] [physical] hazard that requires a control.  Specifically, *** 5
19033 21 CFR 117.135(a)(1) Preventive Controls -  Identify You did not identify a preventive control for a hazard when one was needed.  Specifically, *** 5
19036 21 CFR 117.145(a) Process Controls Monitoring Procedures: Establish Implement You did not [establish] [implement] adequate written procedures for monitoring process controls.  Specifically, *** 5
19062 21 CFR 117.150(a)(1) Sanitation Controls Corrective Action Proced: Estab Implemnt You did not [establish] [implement] adequate written corrective action procedures for sanitation controls.  Specifically, *** 5
938 21 CFR 123.9(c) Official review You did not make available for official review and copying at reasonable times [all records] [all plans and procedures] required by the regulations.  Specifically, *** 4
1176 21 CFR 110.40(f) Insufficient number of Q.C. instruments An inadequate number of instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms.  Specifically,*** 4
1294 21 CFR 110.20(b)(3) Outdoor fermentation Proper precautions to protect food in outdoor bulk fermentation vessels cannot be taken because of deficiencies in plant [construction] [design].  Specifically, *** 4
1471 21 CFR 113.83 Scheduled processes not established Scheduled processes for low-acid foods have not been established by qualified persons having expert knowledge of thermal processing.  Specifically, *** 4
1529 21 CFR 113.89 Process deviation log/file Process deviations were not recorded in a separate file or log that details both the deviations and the actions taken.  Specifically, *** 4
1640 21 CFR 113.100(b) Record form not signed A [processing] [production] record form was not signed or initialed by a processing system operator or other designated person.  Specifically, *** 4
2387 21 CFR 110.80(a)(1) Washing and cleaning Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination.  Specifically, *** 4
2901 21 CFR 113.40(i) Critical factor - scheduled process A critical factor 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, *** 4
3089 21 CFR 114.100(c) Process deviations- identification and records Departures from a scheduled process having a possible bearing on public health or the safety of a food are not [noted] [identified] [recorded] [made the subject of a separate file (or log identifying the appropriate data) delineating them].  Specifically, *** 4
4512 21 CFR 108.25(g) Record retention Failure to prepare, review and retain at [the processing plant] [a reasonably accessible location] for three years all records [of processing] [of deviations in processing] [specified in 21 CFR 114]. Specifically, *** 4
9919 21 CFR 120.10(a) Corrective action - predetermined plan inadequate You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]. Specifically, *** 4
9981 21 CFR 120.12(b)(4) Records - actual values Your records do not [always] contain the actual values and observations obtained during monitoring.  Specifically, *** 4
12720 21 CFR 1.225 Not registered Your food facility is not registered as required.  Specifically, *** 4
12744 21 CFR 120.8(b)(4) HACCP plan - monitoring procedures - none listed 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, *** 4
15302 21 CFR 120.11(a)(2) Calibration, testing - no records You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, *** 4
15381 21 CFR 111.8 Written procedures - hygienic practices You did not [establish] [follow] written procedures for hygienic practices.  Specifically, *** 4
15403 21 CFR 111.12(b) Personnel - quality control operations; responsibilities The personnel you identified to perform quality control operations do not have distinct and separate responsibilities related to performing such operations from those responsibilities that the personnel otherwise have when not performing such operations.  Specifically, *** 4
15442 21 CFR 111.15(b)(1) Physical plant - clean and sanitary You did not maintain your physical plant in a clean and sanitary condition.  Specifically, *** 4
15458 21 CFR 111.20(d)(1)(i) Floors, walls, ceilings Your [floors] [walls] [ceilings] were not designed and constructed so they can be adequately cleaned and kept clean and in good repair.  Specifically, *** 4
15491 21 CFR 111.25 Equipment - procedures You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and utensils.  Specifically, *** 4
15533 21 CFR 111.255(c)   Batch record - follow master Your batch production record did not accurately follow the appropriate master manufacturing record.  Specifically, *** 4
15547 21 CFR 111.260(g) Batch record - results; monitoring Your batch production records did not include the actual results obtained during a monitoring operation. Specifically,  *** 4
15559 21 CFR 111.260(k)(1) Batch record - identifier; labels 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, *** 4
15566 21 CFR 111.260(l)(3) Batch record - approved, released, rejected; batch Your batch production records did not include documentation that quality control personnel approved and released, or rejected, a batch for distribution.  Specifically, *** 4
15573 21 CFR 111.153 Written procedures - product received; packaging, labeling You did not [establish] [follow] written procedures for the requirements for product received for packaging or labeling as a dietary supplement.  Specifically, *** 4
15605 21 CFR 111.165(c) Product received - quarantine  You did not quarantine received product.  Specifically, *** 4
15610 21 CFR 111.165(d)(1)  Product received - identify 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, ***



4
15623 21 CFR 111.180(b)(2) Records - receiving; components, packaging, labels, products You did not make and keep receiving records for [components] [packaging] [labels] [products you received for packaging or labeling as a dietary supplement].  Specifically,  *** 4
15662 21 CFR 111.303 Written procedures - laboratory operations  You did not [establish] [follow] written procedures for laboratory operations. Specifically, *** 4
15734 21 CFR 111.360   Manufacturing operations - sanitation  You did not conduct manufacturing operations in accordance with adequate sanitation principles.  Specifically, *** 4
15755 21 CFR 111.205(c) Master manufacturing record:  readily available  You did not have records or copies of records required for your master manufacturing records readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, *** 4
15760 21 CFR 111.205(b)(1) Master manufacturing record-specifications; packaged, label 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, *** 4
15783 21 CFR 111.410(d) Manufacturing history  You were not able to determine the complete manufacturing history and control of a packaged and labeled dietary supplement through distribution.  Specifically, *** 4
15791 21 CFR 111.403  Written procedures -packaging operations  You did not [establish] [follow] written procedures for packaging operations.  Specifically, *** 4
15800 21 CFR 111.560(a)(2) Product complaint - quality control investigate  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, *** 4
15860 21 CFR 111.75(a)(2) Component - confirm identity; specifications met  You did not confirm the identity of components.  Specifically, *** 4
15939 21 CFR 111.105(g) Quality control - reserve samples Your quality control personnel did not ensure that required reserve samples were collected and held.  Specifically, *** 4
15975 21 CFR 111.120(e)   Quality control operations - quarantine Your quality control operations did not include approving, and releasing from quarantine, all [components] [packaging] [labels] before they were used.  Specifically, *** 4
16070 21 CFR 111.35(b)(2) Document-equipment date of use, maintain, clean, sanitize You did not make and keep documentation of [the date of the use] [maintenance] [cleaning] [sanitizing] of the equipment.  Specifically, *** 4
16139 21 CFR 118.4(c)(1) Satisfactory rodent control methods When your monitoring indicated unacceptable rodent activity within a poultry house, appropriate methods were not used to achieve satisfactory rodent control.  Specifically,*** 4
16152 21 CFR 118.5(a) Testing when laying hens 40 to 45 weeks 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,*** 4
18160 21 CFR 117.80(b)(8)

Raw Materials - Allergen Identification 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, *** 4
18272 21 CFR 1.504(d) Document review entity's hazard analysis 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, *** 4
18281 21 CFR 1.505(a)(2) Evaluation - performance, risk You did not document the evaluation you conducted to determine [a foreign supplier's performance] [the risk posed by a food].  Specifically, *** 4
972 21 CFR 123.8(a)(1) Modification HACCP plan You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate.  Specifically, *** 3
975 21 CFR 123.9(b)(1) Record retention Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period.  Specifically, *** 3
1600 21 CFR 110.37(a) General inadequacy Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source].  Specifically, *** 3
1643 21 CFR 113.100(e) Incomplete information A record of a container closure examination did not specify [the product code] [the date of container closure inspections] [the time of container closure inspections] [the measurements obtained] [all corrective actions taken].  Specifically, *** 3
1688 21 CFR 110.80 Supervisory competence The function of supervising overall sanitation of the plant has not been designated to  the supervision of  one or more competent individuals assigned responsibility for this function.  Specifically, *** 3
1710 21 CFR 110.80(b)(14) Water activity controls Failure to adequately [process to] [maintain at] a safe moisture level foods that rely on the control of water activity to prevent the growth of undesirable microorganisms.  Specifically, *** 3
2391 21 CFR 110.80(a)(6) Thawed appropriately Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated.  Specifically, *** 3
2848 21 CFR 113.40(g)(1)(i)(B)(3) Adjusted to agree with TID A temperature-recording device was not adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature-indicating device during processing.  Specifically, *** 3
3077 21 CFR 114.80(b) Visible code Each container is not marked with an identifying code permanently visible to the naked eye.  Specifically, *** 3
3083 21 CFR 114.89 Process deviation evaluation Process deviations are not evaluated by a competent processing authority in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health.  Specifically, *** 3
3648 21 CFR 110.20(a)(4) Neighboring grounds Failure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control.  Specifically, *** 3
3663 21 CFR 110.40(e) Lack of automatic control / alarm (S) Lack of [an automatic control for regulating  temperature] [an automatic temperature alarm system] for each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms.  Specifically, *** 3
3710 21 CFR 110.80(b)(16) Ice manufacturing Ice in contact with food has been made from water which is [unsafe] [of inadequate sanitary quality].  Specifically, *** 3
3859 21 CFR 113.60(a) Frequency: visual closure examinations, record A qualified container closure inspection person did not record the observations made of [the top seam of a can randomly selected from each seaming head] [the container closures] at intervals of sufficient frequency to ensure proper closure.  Specifically, *** 3
4295 21 CFR 110.40(a) Food contact - non-toxic materials Food-contact surfaces are not made of non-toxic materials.  Specifically, *** 3
4421 21 CFR 110.20(a) Maintenance of grounds Maintenance of the grounds is inadequate to protect against contamination of food.  Specifically, ***  3
4528 21 CFR 108.35(c)(2)(ii) Process change recording 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, *** 3
6009 21 CFR 123.8(a)(3)(iii) Verification - record review - calibration You did not review [some of] your calibration records within a reasonable time after the records were made.  Specifically, *** 3
9926 21 CFR 120.14(a) Importer - written procedures 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, *** 3
12751 21 CFR 120.8(b)(7) HACCP plan - recordkeeping system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical control points.  Specifically, *** 3
15396 21 CFR 111.10(b)(6) Hair restraints Your personnel did not wear [effective] hair restraints [in an effective manner].  Specifically, *** 3
15445 21 CFR 111.15(c)(1) Sanitizing agents You did not use sanitizing agents that [are free from microorganisms of public health significance] [are safe and adequate under the conditions of use].  Specifically, *** 3
15511 21 CFR 111.27(d) Equipment - maintain - general You did not [maintain] [clean] [sanitize] equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements.  Specifically, *** 3
15538 21 CFR 111.255(d)  Batch record - readily available You did not have  batch production records or copies of  batch production records readily available during the required retention period for inspection and copying by FDA when requested.  Specifically,  *** 3
15551 21 CFR 111.260(j)(1)  Batch record - date, each step Your batch production records did not include the date on which each step of the master manufacturing record was performed. Specifically, *** 3
15554 21 CFR 111.260(j)(2)(ii) Batch record - initials; verifying weight 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, *** 3
15558 21 CFR 111.260(k)(1) Batch record - identifier; packaging Your batch production records did not include [the unique identifier assigned to packaging used] [the quantity of the packaging used].  Specifically, *** 3
15563 21 CFR 111.260(l)(1)(i) Batch record - quality control review; monitoring Your batch production records did not include documentation that quality control personnel reviewed required monitoring operations.  Specifically, *** 3
15583 21 CFR 111.155(d)(1) Components - identify lot received 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,  *** 3
15584 21 CFR 111.155(d)(1) Components - identify lot produced  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, *** 3
15600 21 CFR 111.160(d)(2) Packaging, labels - unique identifier, disposition You did not use a unique identifier whenever you recorded the disposition of each unique lot within each unique shipment of [packaging] [labels].  Specifically, *** 3
15619 21 CFR 111.180(b)(1)  Written procedures - packaging, labeling received  You did not make and keep written procedures for fulfilling the requirements that apply to packaging and labeling received.  Specifically, *** 3
15620 21 CFR 111.180(b)(1) Written procedures - product received  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, 3
15671 21 CFR 111.315 Laboratory control  processes - requirements  You did not [establish] [follow] laboratory control processes.  Specifically, *** 3
15723 21 CFR 111.365(i) Metal, foreign material  You did not use effective measures to protect against the inclusion of metal or other foreign material in [components] [dietary supplements].  Specifically, *** 3
15728 21 CFR 111.365(d) Chemical,microbiological,other test-contaminated components You did not perform chemical, microbiological, or other testing, as necessary to prevent the use of contaminated components.  Specifically, *** 3
15739 21 CFR 111.210(h)(3)(ii)(B) Components; add, verify The specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person to add and another person to verify the addition of the components.  Specifically, *** 3
15743 21 CFR 111.210(h)(3)  Master manufacturing record - specific actions; quality  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, *** 3
15752 21 CFR 111.210(c) Master manufacturing record - components; weight, measure  Your master manufacturing record did not include an accurate weight or measure of each component to be used.  Specifically, *** 3
15753 21 CFR 111.210(b) Master manufacturing record - list components Your master manufacturing record did not include a complete list of components to be used.  Specifically, *** 3
15754 21 CFR 111.210(a) Master manufacturing record - dietary ingredients  Your master manufacturing record did not include the [name] [strength] [concentration] [weight] [measure] of each dietary ingredient for each batch size.  Specifically, *** 3
15759 21 CFR 111.205(b)(2) Master manufacturing record - controls, procedures  Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch met specifications. Specifically,  *** 3
15796 21 CFR 111.430(b) Records - packaging, labeling operations  You did not make and keep records of the written procedures for [packaging] [labeling] operations.  Specifically, *** 3
15832 21 CFR 111.70(c)(1) In-process identity, purity, strength, composition 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, *** 3
15864 21 CFR 111.75(a)(2)(ii)(C) Documentation - qualify supplier  You did not maintain documentation of how you qualified the supplier of a component.  Specifically, *** 3
15875 21 CFR 111.75(d)(1) Documentation specifications met; exempted, periodic testing You did not document why an exempted product specification is met without verification by periodically testing the finished batch.  Specifically, *** 3
15882 21 CFR 111.75(h)(2)  Tests, examinations - scientifically valid  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, *** 3
15928 21 CFR 111.103 Written procedure quality control operations material review You did not [establish] [follow] written procedures for quality control operations for conducting a material review and making a disposition decision.  Specifically, *** 3
15944 21 CFR 111.105(i)   QC - required operations master manufacturing/batch records  Your quality control personnel did not perform required operations for the [master manufacturing record] [batch record] [manufacturing operations]. Specifically, *** 3
15983 21 CFR 111.123(a)(7)   Quality control operations - finished batch, specifications Your quality control operations did not include determining whether each finished batch conforms to established product specifications.  Specifically, *** 3
15995 21 CFR 111.127(d)   QC operations - packaged, labeled; specifications Your quality control operations did not include determining whether the finished [packaged] [labeled] dietary supplement conforms to established specifications.  Specifically, *** 3
16008 21 CFR 111.135 Quality control operations - product complaints; investigate Your quality control operations for product complaints did not include [reviewing and approving decisions about whether to investigate a product complaint] [reviewing and approving the findings and follow-up action of any investigation performed].  Specifically, *** 3
16074 21 CFR 111.35(b)(4)  Records - equipment; calibrations, inspections, checks  You did not make and keep written records of calibrations, inspections, or checks of automated, mechanical, or electronic equipment.  Specifically, *** 3
16122 21 CFR 118.4(a)(2)(i) Pullet environment testing Your pullet environment is not tested for SE when pullets are 14 to 16 weeks of age.  Specifically,*** 3
16138 21 CFR 118.4(c)(1) Monitoring for rodents The presence of rodents is not monitored by appropriate monitoring methods.  Specifically,*** 3
16149 21 CFR 118.4(e) Egg transport temperature/time Eggs were not [held ] [transported] at or below 45 deg. F beginning 36 hours after time of lay.  Specifically,*** 3
18295 21 CFR 1.506(d)(1)(i) Verification activity assurance 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, *** 3
18559 21 CFR 1.512(b)(1)(i)(A) Definition very small importer 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, *** 3
18562 21 CFR 1.512(b)(2) Develop FSVP You did not develop an FSVP.  Specifically, *** 3
19042 21 CFR 117.150(d) Process Controls Corrective Action Records You did not have process controls corrective action records.  Specifically, *** 3
19048 21 CFR 117.135(c)(2) Allergen Controls Procedures Your allergen controls procedures did not include appropriate controls for [protection of food from allergen cross-contact] [labeling].  Specifically, *** 3
19049 21 CFR 117.145(a) Allergen Controls Monitoring Proced: Establish Implement You did not [establish] [implement] adequate written procedures for monitoring allergen controls.  Specifically, *** 3
1188 21 CFR 110.37(c) Sewage disposal Failure to dispose of sewage into an adequate sewerage system or by other adequate means.  Specifically, *** 2
1245 21 CFR 113.81(a) Raw ingredients There was no means to assure that raw materials and ingredients susceptible to microbiological contamination were suitable for use in processing low-acid food.  Specifically, *** 2
1290 21 CFR 110.20(a)(4) Waste disposal Failure to properly maintain operating systems for waste treatment and disposal so that they do not constitute a source of contamination in areas where food is exposed.  Specifically, *** 2
1487 21 CFR 113.87(b) Visual indicators not used 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, *** 2
1533 21 CFR 113.100(b) Recording device records - dated; retort number 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, *** 2
1641 21 CFR 113.100(b) Review not timely 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, *** 2
2149 21 CFR 113.40(b)(1)(v) TID not reference instrument The reference instrument for indicating the processing temperature was not a temperature-indicating device.  Specifically, *** 2
2166 21 CFR 113.40(b)(7) Flexible containers Dividers, racks, trays, or other means of positioning of flexible containers were not [designed] [employed] to ensure even circulation of the heating medium around all containers in the retort.  Specifically, *** 2
2274 21 CFR 129.80(g)(1) Bacteriological test - bottled water 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, *** 2
2362 21 CFR 110.80 Reject and rework Food which has become contaminated to the extent of being adulterated within the meaning of the Act is not rejected or if permissible, treated or processed to eliminate the contamination..  Specifically, *** 2
2886 21 CFR 113.40(i) Thermal process crit factors-measurement adequate & accurate The [time] [temperature] of processing [was] [were] not measured with an instrument having the accuracy and dependability adequate to ensure that the requirements of the scheduled process were met.  Specifically, *** 2
2887 21 CFR 113.40(j) Processing: conform to other systems A system for processing a low-acid food in hermetically sealed containers did not conform to the requirements for [manufacturing] [processing] [packing] low-acid foods.  Specifically, *** 2
3068 21 CFR 114.80(a)(1) pH control 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,  *** 2
3072 21 CFR 114.80(a)(1) Thermal processing 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, *** 2
3074 21 CFR 114.80(a)(2) Using pH meter Failure to [use a potentiometer to measure pH] [relate in-process measurements by titration or colorimetry to the finished equilibrium pH] when the finished equilibrium pH is above 4.0. Specifically, *** 2
3651 21 CFR 110.37(b)(5) Cross contamination Systems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing.  Specifically, *** 2
3708 21 CFR 110.80(a)(1) Water quality -- wash, rinse, convey food Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality].  Specifically, *** 2
3876 21 CFR 113.60(c) Coding - no mark, permanently visible Hermetically sealed containers of low-acid processed food were not marked with an identifying code [that was permanently visible to the naked eye].  Specifically, *** 2
4069 21 CFR 113.40(b)(14) Heat distribution data, other retort installation 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, *** 2
4179 21 CFR 113.83 Records of process establishment 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, *** 2
4419 21 CFR 110.10(c) Level of competency (S) Personnel responsible for identifying [sanitation failures] [food contamination] lack a background of education and experience to provide a needed level of competency.  Specifically, *** 2
4527 21 CFR 108.25(g) Record retention and copying Failure to permit [inspection] [copying] of records [of processing] [of deviations in processing] [specified in 21 CFR 114], upon written demand by FDA, to verify pH and the adequacy of processing. Specifically, *** 2
4529 21 CFR 108.35(c)(2)(ii) Process change reporting to CFSAN For an intentional change in a previously filed scheduled process, failure to submit to CFSAN, 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, *** 2
6012 21 CFR 123.8(a)(3)(iii) Calibration record review adequacy 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, ***  2
6017 21 CFR 123.7(c) Corrective action per regulation 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, *** 2
9921 21 CFR 120.10(b) Corrective action - no predetermined plan Your HACCP plan does not include a corrective action plan.  There was a deviation from a critical limit and you did not take corrective action that ensured [affected product was segregated and held] [a review of the affected product by someone who is adequately trained or experienced was done to determine its acceptability] [product that was injurious to health or otherwise adulterated was not entered into commerce] [the cause of the deviation was corrected] [the HACCP plan was verified by someone meeting the training requirements of the regulation to determine if modifications were needed to reduce the risk of recurrence of the deviation and to modify the HACCP plan as necessary].  Specifically, *** 2
9936 21 CFR 120.7(a) Hazard analysis - written - elements 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, *** 2
9946 21 CFR 120.11(b) Validation - reviewer's qualifications 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, *** 2
9962 21 CFR 120.24(b) Process controls - direct treatment  - not exempt Your treatments intended to achieve a 5-log reduction in the most resistant microorganism of public health significance are not applied directly to the juice, and the exemption for surface treatment of fruit does not apply.  Specifically, *** 2
15351 FDCA 761(b)(1) No AE report made (dietary supplement) No report was made of a serious adverse event associated with a dietary supplement marketed in the United States.  Specifically, *** 2
15380 21 CFR 111.8 Written procedures - sick or infected personnel You did not [establish] [follow] written procedures for preventing microbial contamination from sick or infected personnel.  Specifically, *** 2
15382 21 CFR 111.8 Written procedures - personnel qualifications You did not [establish] [follow] written procedures for determining personnel qualification requirements.  Specifically, *** 2
15398 21 CFR 111.10(b)(8) Food, gum, beverages, tobacco 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, *** 2
15400 21 CFR 111.12(a) Personnel - qualified - general Your personnel are not qualified to [manufacture] [package] [label] [hold] dietary supplements.  Specifically, *** 2
15409 21 CFR 111.14(b)(1) Personnel - records - written procedures You did not make and keep written procedures for [preventing microbial contamination from sick or infected personnel] [hygienic practices] [determining personnel qualification requirements].  Specifically, *** 2
15436 21 CFR 111.15(a) Grounds - condition You did not keep the grounds of your physical plant in a condition that protects against contamination.  Specifically, *** 2
15437 21 CFR 111.15(a)(1) Grounds - equipment, litter, weeds You did not [properly store equipment] [remove litter and waste] [cut weeds or grass] within the immediate vicinity of the physical plant.  Specifically, ***        2
15444 21 CFR 111.15(c)(1) Cleaning compounds 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, *** 2
15456 21 CFR 111.20(b) Physical plant - space; equipment, materials Your physical plant did not have adequate space for the orderly placement of equipment and holding of materials as necessary [for maintenance, cleaning, and sanitizing operations] [to prevent contamination and mix-ups of components and dietary supplements].  Specifically, *** 2
15459 21 CFR 111.20(d) Physical plant - design and construction Your physical plant was not [designed] [constructed] in a manner that prevents contamination of components, dietary supplements, or contact surfaces.  Specifically, *** 2
15462 21 CFR 111.20(d)(1)(iv) Physical plant - temperature, humidity controls Your physical plant did not have equipment that controls temperature and humidity when it is necessary to ensure the quality of the dietary supplement.  Specifically, *** 2
15493 21 CFR 111.25(b) Procedures - calibrating automated, mechanical equip You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.  Specifically, *** 2
15507 21 CFR 111.27(a)(5)(i) Refrigerator, freezer - temperature recording device 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, *** 2
15518 21 CFR 111.27(d)(4) Contact surfaces - not in direct contact - cleaning You did not clean surfaces that do not come into direct contact with components or dietary supplements as frequently as necessary to protect against contaminating components or dietary supplements.  Specifically, *** 2
15521 21 CFR 111.27(d)(6) Cleaning compounds - adequate, safe Cleaning compounds or sanitizing agents were not [adequate for their intended use] [safe under their conditions of use].  Specifically, *** 2
15542 21 CFR 111.260(b)  Batch record - date, time; maintenance Your batch production records did not include the identity of equipment and processing lines used in producing the batch.  Specifically, *** 2
15552 21 CFR 111.260(j)(2)  Batch record - initials; each step Your batch production records did not include initials of the persons performing each step.  Specifically, *** 2
15560 21 CFR 111.260(k)(2) Batch record - label 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, *** 2
15572 21 CFR 111.153  Written procedures - labels  You did not [establish] [follow] written procedures for the requirements for labels received.  Specifically, *** 2
15597 21 CFR 111.160(c)(3) Labels - quality control; approve, release Your quality control personnel did not approve labels for use in the manufacture of a dietary supplement and release them from quarantine.  Specifically, *** 2
15598 21 CFR 111.160(d)(1) Packaging - identify  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, *** 2
15604 21 CFR 111.165(b) Product received - visually examine invoice, guarantee, cert You did not visually examine the supplier's invoice, guarantee, or certification in a shipment of received product to ensure that the received product was consistent with your purchase order.  Specifically, *** 2
15607 21 CFR 111.165(c)(2) Product received - quality control; documentation; specs Your quality control personnel did not review and approve documentation to determine whether quarantined received product meets established specifications.  Specifically,  *** 2
15614 21 CFR 111.170  Quarantine  component, package, labels, rejected product You did not clearly identify, hold, and control under a quarantine system for appropriate disposition [a component] [packaging] [labels] [product] that you received for packaging or labeling as a dietary supplement that was rejected and unsuitable for use in manufacturing, packaging, or labeling operations.  Specifically, *** 2
15650 21 CFR 111.465(a) Hold - reserve samples; contamination, deterioration  You did not hold reserve samples of dietary supplements in a manner that protects against contamination or deterioration.  Specifically, *** 2
15665 21 CFR 111.303 Written procedures - tests, examinations; specifications met You did not [establish] [follow] written procedures for the tests and examinations conducted to determine whether specifications are met.  Specifically, *** 2
15681 21 CFR 111.315(d) Standard reference materials; criteria for selecting You did not [establish] [follow] laboratory control processes for use of criteria for selecting standard reference materials used in performing tests and examinations.  Specifically, *** 2
15698 21 CFR 111.320(a) Examination, testing; appropriate You did not verify that the laboratory examination and testing methodologies are appropriate for their intended use.  Specifically, *** 2
15715 21 CFR 111.375(b) Records - manufacturing operations; written procedures  You did not make and keep records of the written procedures for manufacturing operations.  Specifically, *** 2
15733 21 CFR 111.365  Manufacturing operations - prevent contamination  You did not take necessary precautions during the manufacture of a dietary supplement to prevent contamination of [components] [dietary supplements].  Specifically, *** 2
15740 21 CFR 111.210(h)(3)(ii)(A)   Instructions; components; weight, measure The specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person weighing or measuring and another person verifying the weight or measure of components.  Specifically, *** 2
15741 21 CFR 111.210(h)(3)(i) Components, verify weight,  measure The written instructions in your master manufacturing record did not include instructions to verify the weight or measure and addition of components.  Specifically,  *** 2
15749 21 CFR 111.210(e)   Master manufacturing record - intentional overage  Your master manufacturing record did not include a statement of intentional overage amount of a dietary ingredient.  Specifically, *** 2
15765 21 CFR 111.430(a) Packaging, labeling operations:originals, copies, electronic You did not keep the records required for your packaging and labeling operations as original records, true copies, or as electronic records.  Specifically, *** 2
15774 21 CFR 111.415(f)(1) Batch-lot,control number packaged, labeled dietary supplemen 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, *** 2
15799 21 CFR 111.560(a)(1) Product complaint - quality control review  A qualified person did not review a product complaint to determine whether the product complaint involves a possible failure of a dietary supplement to meet specifications or any other requirements.  Specifically, *** 2
15801 21 CFR 111.560(b) Quality control, review, approve; investigate, follow-up 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, *** 2
15810 21 CFR 111.570(b)(2)  Record - product complaint; good manufacturing practice  You did not make and keep a written record of every product complaint that was related to good manufacturing practice.  Specifically, *** 2
15821 21 CFR 111.60(a) Production, in- process control system - design, quality 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 supplement.  Specifically, *** 2
15834 21 CFR 111.70(c)(2) Specifications identity, purity strength, composition  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, *** 2
15842 21 CFR 111.70(f) Specifications - product received for packaging, labeling  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, *** 2
15845 21 CFR 111.73 Specifications met - quality  You did not determine whether you met specifications established to ensure the quality of the dietary supplement.  Specifically, *** 2
15867 21 CFR 111.75(b)(1) Specifications met, in-process - quality finished batch  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, *** 2
15868 21 CFR 111.75(b)(2) Specifications met - deviation, unanticipated occurrence  You did not monitor the in-process points, steps, or stages to detect any deviation or unanticipated occurrence that may result in a failure to meet specifications.  Specifically, *** 2
15870 21 CFR 111.75(c)(1) Specifications met - verify; production, process control  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, *** 2
15878 21 CFR 111.75(e)  Product - visually examine, identified   You did not [visually examine a product that you received for packaging or labeling] [have documentation that the product you received for packaging or labeling is adequately identified and is consistent with your purchase order].  Specifically, *** 2
15883 21 CFR 111.75(i)  Corrective action plan  You did not establish a corrective action plan to use when an established specification is not met.  Specifically, *** 2
15898 21 CFR 111.83(b)(1) Reserve sample -container-closure system  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, *** 2
15903 21 CFR 111.87 Material review, disposition - quality control  Your quality control personnel did not [conduct required material reviews] [make required disposition decisions].  Specifically, 2
15935 21 CFR 111.105(d)   Quality control - basis; tests, examinations Your quality control personnel did not review and approve the documentation setting forth the basis for 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, *** 2
15952 21 CFR 111.113 Quality control operations - material review, disposition You do not have quality control operations for a material review and disposition decision.  Specifically, *** 2
15953 21 CFR 111.113(a)(1)   QC production, process control; material review, disposition 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, *** 2
15955 21 CFR 111.113(a)(3)   Quality control - adulteration; material review, disposition 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, *** 2
15964 21 CFR 111.113(c)   Document - material review, disposition 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, *** 2
15976 21 CFR 111.123 Quality control operations - master, batch, manufacturing You do not have quality control operations required  for the [master manufacturing record] [batch production record] [manufacturing operations].  Specifically, *** 2
16017 21 CFR 111.140(b)(3)   Records - material review, disposition You did not make and keep documentation of your material review and disposition decision. Specifically, *** 2
16037 21 CFR 111.605  Records - keep: 1 year, 2 years  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, *** 2
16065 21 CFR 111.35(b)(1) Written procedures - equipment, utensils; make, keep  You did not make and keep written procedures for fulfilling the requirements for equipment and utensils.  Specifically, *** 2
16068 21 CFR 111.35(b)(1)(iii) Equipment, utensils; maintaining, cleaning, sanitizing  You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] equipment and utensils that are used to manufacture, package, label, or hold components or dietary supplements.  Specifically, *** 2
16071 21 CFR 111.35(b)(3) Documentation - instruments, controls; calibrations  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, *** 2
16132 21 CFR 118.4(b)(1) Limiting visitors Visitors are not limited [on the farm] [in the poultry houses].  Specifically,*** 2
16134 21 CFR 118.4(b)(3) Cross contamination from people You do not maintain practices that will protect against cross contamination when people move between poultry houses.  Specifically,*** 2
16140 21 CFR 118.4(c)(2) Monitoring for flies The presence of flies is not monitored by appropriate monitoring methods. Specifically,*** 2
16156 21 CFR 118.5(b) Environmental testing after induced molting period 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,*** 2
16190 21 CFR 118.10(a)(1) Written SE prevention plan You do not have a written SE prevention plan.  Specifically,***  2
16192 21 CFR 118.10(a)(3)(1) Biosecurity measures documentation You did not maintain records documenting compliance with biosecurity measures.  Specifically,*** 2
16193 21 CFR 118.10(a)(3)(ii) Rodent and pest control documentation   You did not maintain records documenting compliance with rodent and other pest control measures.  Specifically,*** 2
16203 21 CFR 118.10(b)(1) Name and location  All required records do not include [your name] [the location of your farm].  Specifically,*** 2
16288 21 CFR 113.100(b) Review of processing and production records 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, *** 2
16510 FDCA 402(a)(4) On farm processing of shell eggs 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, *** 2
18150 21 CFR 117.40(e)

Temperature Devices Your cold storage unit used to store and hold food did not have a temperature device [installed] [installed to show temperature accurately].  Specifically, *** 2
18156 21 CFR 117.80(b)(1)

Raw Material Control - Cleaning - Water Quality You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.  Specifically, *** 2
18290 21 CFR 1.506(a)(1) Procedures - establish, approve supplier 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 food.  Specifically, *** 2
18397 21 CFR 117.4 Management responsibilities - qualified individuals You did not ensure that all individuals are qualified to perform their duties.  Specifically, *** 2
18399 21 CFR 117.305

Training Records - general requirements Your training records did not meet general record requirements.  Specifically, *** 2
18401 21 CFR 117.320

Record Availability You did not [promptly] provide records for [review] [copying].  Specifically, *** 2
18682 21 CFR 106.20(i)

Toilet, hand washing facilities - readily accessible You did not provide employees with readily accessible [toilet facilities] [hand washing facilities].  Specifically, *** 2
19027 21 CFR 117.126(a)(1) Food Safety Plan You [did not have] [did not implement] a written food safety plan.  Specifically, *** 2
19029 21 CFR 117.310 Food Safety Plan - Signing Your food safety plan was not signed and dated [upon initial completion] [when modified].  Specifically, *** 2
19039 21 CFR 117.150(a)(1) Process Controls Corrective Action Proced: Estab Implement You did not [establish] [implement] adequate written corrective action procedures for process controls.  Specifically, *** 2
19043 21 CFR 117.165(a)(4) Process Controls Record Review 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, *** 2
19056 21 CFR 117.165(b) Allergen Controls Verif Procedures: Establish Implement You did not [establish] [implement] adequate written allergen controls verification procedures.  Specifically, *** 2
19064 21 CFR 117.150(d) Sanitation Controls Corrective Action Records You did not have sanitation controls corrective action records.  Specifically, *** 2
939 21 CFR 123.9(f) Computerized records Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.  Specifically, *** 1
977 21 CFR 123.9(b)(3) Records stored at another location You did not immediately return your records for official review upon demand.  Specifically, *** 1
1040 21 CFR 113.10 Operators 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, *** 1
1060 21 CFR 123.11(a) SSOP(S) You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP).  Specifically, *** 1
1255 21 CFR 129.20(a) Bottling room separation, plant operations The bottling room was not separated from other plant operations by [tight walls] [ceilings] [self-closing doors] to protect against contamination.  Specifically, *** 1
1277 21 CFR 129.20(d) Wash, sanitize - enclosed room You did not [wash] [sanitize] containers for bottled drinking water in an enclosed room.  Specifically, *** 1
1300 21 CFR 113.81(c) Fill The filling of containers is not controlled to ensure that the filling requirements specified in the scheduled process are met.  Specifically, *** 1
1302 21 CFR 113.81(e) pH The equilibrium pH of the finished product is not controlled so as to meet the pH requirements in the scheduled process.  Specifically, *** 1
1324 21 CFR 113.100(f) Distribution record Records were not maintained to identify the initial distribution of finished product.  Specifically, *** 1
1329 21 CFR 113.100(a) Process records - not done; not timely 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, *** 1
1334 21 CFR 113.100(a)(4) Aseptic processing - records For an aseptic processing and packaging system, records were not maintained for [product temperature in the holding tube outlet] [differential pressure] [product flow rate] [sterilization media flow rate] [sterilization media temperature] [retention time of containers] [retention time of closures] [sterilization cycle times] [sterilization cycle temperatures].  Specifically, *** 1
1417 21 CFR 129.37(c) Single-service container, cap, seal-exam, sanitize, handle 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, *** 1
1453 21 CFR 129.40(a)(1) Suitability - equipment, utensils Plant equipment or utensils were not suitable for their intended use.  Specifically, *** 1
1473 21 CFR 113.83 Scheduled process - scientific methods not used Acceptable scientific methods for establishing heat sterilization processes were not used in establishing a scheduled process.  Specifically, *** 1
1484 21 CFR 113.87(a) Vent not posted 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, *** 1
1488 21 CFR 113.87(b) Post processing - visual check of indicator not done A visual check of the heat-sensitive indicator was not performed to ensure that containers had been retorted .  Specifically, *** 1
1499 21 CFR 113.89 No corrective action taken 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, *** 1
1500 21 CFR 113.89 Evaluation by process authority Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority.  Specifically, *** 1
1531 21 CFR 113.100(a)(6) Water activity - critical factor For a food preservation method for which another critical factor was used in conjunction with thermal processing, records were not maintained for [the product formulation] [the scheduled processes used] [a critical factor].  Specifically, *** 1
1563 21 CFR 110.35(d)(1) Low-moisture food requirements Food contact surfaces used for [manufacturing] [holding] low-moisture food were [wet] [insanitary] at time of use.  Specifically, *** 1
1569 21 CFR 110.35(d)(2) Continuous operations Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary.  Specifically, *** 1
1595 21 CFR 110.37(b)(1) Sufficient quantities of water Plumbing is not [of adequate size and design] [adequately installed and maintained] to carry sufficient quantities of water to required locations throughout the plant.  Specifically, *** 1
1639 21 CFR 113.100(b) Entry not timely 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, *** 1
1645 21 CFR 113.100(e) Insufficient frequency of management review Records of container closure examinations were not reviewed by management with sufficient frequency to ensure that the containers were hermetically sealed.  Specifically, *** 1
1649 21 CFR 113.40(a)(1)(iv) MIG - range The temperature range of a mercury-in-glass thermometer exceeded 17 ?F per inch (4 ?C per centimeter) of graduated scale.  Specifically, ***  1
1651 21 CFR 113.40(a)(1) TID accuracy test frequency 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, *** 1
1665 21 CFR 110.80(a)(2) Pasteurization or other adequate treatment [Raw materials] [Ingredients] which contain levels of microorganisms that may produce food poisoning or other disease are not pasteurized or otherwise adequately treated.  Specifically, *** 1
1669 21 CFR 110.80(a)(3) Aflatoxin and other natural toxins There is no assurance that [raw materials] [ingredients] which are susceptible to contamination with aflatoxin or other natural toxins comply with current FDA standards before being incorporated into food.  Specifically, *** 1
1708 21 CFR 110.80(b)(12) Batters, breading, gravies, sauces, etc. Failure to treat and maintain [batters] [breading] [sauces] [gravies] [dressings and similar preparations] in a manner that protects against [contamination] [growth of microorganisms].  Specifically, *** 1
1716 21 CFR 113.40(a)(11) Water valves, leakage 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, *** 1
1732 21 CFR 113.40(a)(2)(i) Range, chart graduations 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, ***  1
1734 21 CFR 113.40(a)(2)(iii) Adjusted to agree with TID 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, *** 1
1752 21 CFR 113.40(a)(8) Location - from ends Bleeders for a horizontal still retort were not located within approximately 1 foot (30.5 centimeters) of the outermost locations of containers at each end along the top of the retort and there was no evidence in the form of heat distribution data that adequate removal of air and circulation of steam within the retort was accomplished.  Specifically, ***  1
1757 21 CFR 113.40(a)(8) Observable A bleeder was not arranged so that the operator could observe that it was functioning properly.  Specifically, *** 1
1761 21 CFR 129.80(a) Records - equipment inspection 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, *** 1
1806 21 CFR 129.80(b)(1) Mechanical washers - records You did not keep records of [inspections and conditions found] [physical maintenance] [performance] for mechanical washers. Specifically, *** 1
1812 21 CFR 129.80(c) Sample, test - cleaning, sanitizing solutions You did not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance.  Specifically, *** 1
1865 21 CFR 113.40(a)(12) Timing before vent, before temperature reached Timing of a process began [before the retort was properly vented] [before the processing temperature was reached].  Specifically, *** 1
2142 21 CFR 113.40(b)(1) No accurate TID Each retort did not have at least one temperature-indicating device that accurately indicated the temperature during processing.  Specifically, *** 1
2153 21 CFR 113.40(b)(2)(iii) Adjusted to agree with TID 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, *** 1
2154 21 CFR 113.40(b)(2)(iii) Unauthorized adjustment A means of preventing unauthorized adjustment to the temperature-recording device was not provided.  Specifically, ***  1
2169 21 CFR 113.40(b)(10) Operator check, record, frequency The operator did not [check] [record] the water level in the retort [at intervals sufficient to ensure its adequacy].  Specifically, *** 1
2206 21 CFR 113.40(b)(15) Measured, recorded 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, *** 1
2275 21 CFR 129.80(g)(2) Chemical, physical, radiological tests - bottled water 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, *** 1
2301 21 CFR 129.80(f) Bacteriological swab, rinse count - containers, closures (S) 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, *** 1
2369 21 CFR 129.80(a) Treatment product water - equipment, substances You treated product water [in and by equipment] [with substances] that may have adulterated the bottled product. Specifically, *** 1
2389 21 CFR 110.80(a)(5) Identify rework Failure to identify material scheduled for rework as such. Specifically, *** 1
2390 21 CFR 110.80(a)(6) Kept frozen prior to use Failure to keep frozen raw materials frozen prior to use.  Specifically, *** 1
2427 21 CFR 110.80(b)(9) Proper disposal of adulterated product Failure to dispose of adulterated [food] [raw materials] in a manner which protects against the contamination of other food.  Specifically, *** 1
2428 21 CFR 110.80(b)(9) Proper reconditioning Failure to use a proven effective method of reconditioning adulterated food.  Specifically, *** 1
2503 21 CFR 113.40(e)(2)(iii) Unauthorized adjustment A means of preventing unauthorized adjustment to the temperature-recording device was not provided.  Specifically, *** 1
2843 21 CFR 113.40(g)(1)(i)(A)(5) TID not reference instrument The reference instrument for indicating the processing temperature was not a temperature-indicating device.  Specifically, *** 1
2852 21 CFR 113.40(g)(1)(i)(C) Range Graduations on the temperature recorder-controller chart exceeded 2 degrees F within a range of 10 degrees F of the product sterilization  temperature.  Specifically, *** 1
2860 21 CFR 113.40(g)(1)(i)(F) Unauthorized flow adjustments A means of preventing unauthorized adjustments to the flow control device was not provided.  Specifically, *** 1
2896 21 CFR 113.40(g)(2)(ii)(B) Packaging deviation - segregate product Product that was packaged under conditions below those specified in the scheduled process was not segregated from product that received the scheduled process.  Specifically, *** 1
2898 21 CFR 113.40(g)(2)(ii)(C) Operating conditions observed, recorded - frequency 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, *** 1
3079 21 CFR 114.80(b) Code - packing period The packing period is not changed often enough to enable ready identification of lots during sale and distribution  Specifically, *** 1
3091 21 CFR 114.100(e) Retention 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, *** 1
3649 21 CFR 110.35(d)(1) Dry and sanitary Failure to keep food-contact surfaces used in the [manufacture] [holding] of low-moisture food in a dry, sanitary condition at the time of use.  Specifically, *** 1
3773 21 CFR 113.40(a)(7) Number and size of steam spreader perforations (S) In a still steam retort, the total cross-sectional area of steam spreader perforations was [less than 1 1/2] [greater than 2] times the cross-sectional area of the smallest restriction in the steam inlet line.  Specifically, *** 1
3864 21 CFR 113.60(a)(1) Recording of teardown examinations Teardown examinations for double-seam cans were not performed on enough containers from each seaming station to ensure maintenance of seam integrity.  Specifically, *** 1
3865 21 CFR 113.60(a)(1) Teardown examinations - record of corrective action Corrective action taken for closure defects revealed during can seam teardown examinations was not recorded.  Specifically, *** 1
3866 21 CFR 113.60(a)(1)(i)(a) Required can seam measurements (micrometer) Measurements were not [taken] [recorded] for the can seam [cover hook] [body hook] [width (length, height)] [tightness] [thickness].  Specifically, *** 1
3871 21 CFR 113.60(a)(2) Record of cold water vacuum check The results of glass container capper cold water vacuum tests were not recorded.  Specifically, *** 1
3887 21 CFR 113.89 Methods of process deviation evaluation Failure to use procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health in the evaluation of a deviation from the scheduled process.  Specifically, *** 1
3892 21 CFR 113.60(a) Regular observations for gross closure defects Regular observations for gross container closure defects were not made during production runs.  Specifically, *** 1
4067 21 CFR 113.40(a)(12)(iii) Venting, other installations You did not have evidence in the form of heat distribution data that adequate venting of air is accomplished for a retort installation that deviates from established air venting requirements for still retorts.  Specifically, *** 1
4465 21 CFR 114.100(c) Process deviations - action to rectify Failure to record the action taken to rectify a departure from a scheduled process.  Specifically, *** 1
4517 21 CFR 108.35(c)(2)(ii) Process change substantiation Failure to obtain substantiation by a qualified scientific authority as to the adequacy of any intentional change in a previously filed scheduled process, where the change is basic to the adequacy of that scheduled process.  Specifically, *** 1
4518 21 CFR 108.35(c)(2)(ii) Process change - increase Failure to file with FDA changes in previously filed scheduled processes, where processing parameters were higher or longer, when the processes became regularly scheduled.  Specifically, *** 1
4521 21 CFR 108.35(d) Notify FDA - spoilage Failure to notify FDA about [spoilage] [process deviations] of potential public health significance when all or part of a lot was distributed. Specifically, *** 1
6011 21 CFR 123.8(a)(3)(ii) Corrective action record review adequacy Your review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions have been taken].  Specifically, *** 1
9929 21 CFR 120.12(b)(4) Records - information not entered when observed Processing and other information is not [always] entered on your records at the time it is observed.  Specifically, *** 1
9933 21 CFR 120.6(b) GMP correction - timely  You do not [always] correct deficiencies from good manufacturing practice in a timely manner.  Specifically, *** 1
9943 21 CFR 120.8(a) HACCP plan - location and type of juice Your HACCP plan is not specific to [each location where juice is processed] [each type of juice processed].  Specifically, *** 1
9949 21 CFR 120.11(b) HACCP plan not modified You did not immediately modify your HACCP plan  after a validation revealed that the plan was no longer adequate.  Specifically, *** 1
9953 21 CFR 120.11(a)(1)(iv)(A) CCP record review adequacy 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, *** 1
9963 21 CFR 120.24(c) Process controls - exempt process, single facility You do not process and perform final product packaging in a single facility operating under current good manufacturing practices.  Specifically, *** 1
12701 21 CFR 129.35(a)(4)(iii) Testing for disinfectants & DBPs Your [product] [operations] source water from a non-public source has been treated with a chlorine-based disinfectant or ozone, but has not been tested for residual disinfectants and disinfection by-products that are likely to result from such treatment.  Specifically, *** 1
12703 21 CFR 129.80(a) Product water samples after processing You did not take product water samples after processing and prior to bottling. Specifically, *** 1
12754 21 CFR 120.11(a)(1)(iv)(C) Calibration, testing - record review adequacy Your review of [calibration of process monitoring instruments] [periodic end-product testing] [periodic in-process testing] records does not ensure that [the records are complete] [the activities occurred in accordance with your written procedures].  Specifically, *** 1
15001 21 CFR 113.60(a)(1) Closure examinations - corrective actions taken and recorded Corrective action was not taken for closure defects revealed by teardown examinations of double-seam cans.  Specifically, *** 1
15304 21 CFR 120.12(g) Records - computerized Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.  Specifically, *** 1
15305 21 CFR 120.14(a)(2) Importer - implementation of affirmative steps You have not implemented affirmative steps to ensure juice you receive for import into the United States was processed in accordance with the juice HACCP regulation. Specifically, ***  1
15358 FDCA 761(c)(1) Timing of AE report submission (dietary supplement) An adverse event report for a dietary supplement was not submitted to the Secretary of HHS within 15 business days of receipt of the report,. Specifically, *** 1
15388 21 CFR 111.10(b) Personnel - hygienic practices Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.  Specifically, *** 1
15392 21 CFR 111.10(b)(4) Jewelry and objects - remove Your personnel did not remove unsecured [jewelry] [objects] that might fall into components, dietary supplements, equipment, or packaging.  Specifically, *** 1
15395 21 CFR 111.10(b)(5) Gloves Your personnel used gloves that were not [intact] [clean] [in a sanitary condition] [made of impermeable material].  Specifically, *** 1
15397 21 CFR 111.10(b)(7) Personal belongings Your personnel stored clothing or other personal belongings in areas where [components, dietary supplements, or contact surfaces are exposed] [contact surfaces are washed].  Specifically, *** 1
15411 21 CFR 111.14(b)(2) Personnel - records - training date, type, persons Your training documentation did not include the [date of the training] [type of training] [persons trained].  Specifically, *** 1
15427 21 CFR 111.15(h) Bathrooms - adequate, accessible You did not provide your employees with [adequate] [readily accessible] bathrooms.  Specifically, *** 1
15428 21 CFR 111.15(h) Bathrooms - clean Your bathrooms [were not clean] [were a potential source of contamination to components, dietary supplements, or contact surfaces].  Specifically, *** 1
15429 21 CFR 111.15(k) Sanitation supervisors - assigned You did not assign one or more employees to supervise overall sanitation.  Specifically, *** 1
15438 21 CFR 111.15(a)(2) Roads, yards, parking lot You did not maintain [roads] [yards] [parking lots] so that they do not constitute a source of contamination in areas where components, dietary supplements, or contact surfaces are exposed.  Specifically, *** 1
15449 21 CFR 111.15(f)(2) Plumbing - sewage, liquid waste The plumbing in your physical plant was not adequate to properly convey sewage and liquid disposable waste from your physical plant.  Specifically, *** 1
15450 21 CFR 111.15(f)(3) Plumbing - source of contamination The plumbing in your physical plant was not adequate to avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface or creating an unsanitary condition.  Specifically, *** 1
15452 21 CFR 111.15(f)(5) Plumbing - backflow, cross connection The plumbing in your physical plant allows [backflow from] [cross connection between] piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities.  Specifically, *** 1
15461 21 CFR 111.20(d)(1)(iii) Physical plant - ventilation, environmental control Your physical plant did not have [adequate ventilation] [environmental control equipment] to minimize odors and vapors in areas where they may contaminate components, dietary supplements, or contact surfaces.  Specifically, ***  1
15466 21 CFR 111.20(c) Physical plant - prevent mix-ups, contamination 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, *** 1
15469 21 CFR 111.20(c)(3) Physical plant - separate areas for products 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, *** 1
15475 21 CFR 111.20(e)(1) Adequate light - processing, holding Your physical plant did not provide adequate light in areas where components or dietary supplements are [examined] [processed] [held].  Specifically, *** 1
15478 21 CFR 111.20(f) Physical plant - bulbs, fixtures, skylights You did not use safety-type [light bulbs] [fixtures] [skylights] [glass] over exposed components or dietary supplements.  Specifically, *** 1
15505 21 CFR 111.27(a)(3)(v) Equipment - protect from contamination Your equipment or utensils are not maintained to protect components and dietary supplements from being contaminated.  Specifically, *** 1
15506 21 CFR 111.27(a)(4) Equipment - bonded seams 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, *** 1
15508 21 CFR 111.27(a)(5)(ii) Refrigerator, freezer - alarm 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, *** 1
15513 21 CFR 111.27(d)(2) Contact surfaces - low moisture products You did not ensure that contact surfaces used for manufacturing or holding low-moisture components or dietary supplements were [dry] [sanitary].  Specifically, *** 1
15522 21 CFR 111.27(d)(7) Portable equipment - store You did not store cleaned and sanitized portable equipment used to manufacture, package, label, or hold components or dietary supplements [in a manner] [in a location] that protects it from contamination.  Specifically, *** 1
15523 21 CFR 111.27(d)(7) Utensils - store You did not store cleaned and sanitized utensils that are used to manufacture, package, label, or hold components or dietary supplements [in a manner] [in a location] that protects them from contamination.  Specifically, *** 1
15525 21 CFR 111.30(b) Equipment - automated - suitability You did not determine the suitability of the automated, mechanical, or electronic equipment by ensuring that the equipment is capable of operating satisfactorily within the operating limits required by the process.  Specifically, *** 1
15548 21 CFR 111.260(h) Batch record - results; testing, examination; batch Your batch production records did not include the results of testing or examination performed during batch production, or a cross-reference to such results.  Specifically, *** 1
15549 21 CFR 111.260(i) Batch record - specifications Your batch production records did not include documentation that the finished dietary supplement meets established specifications.  Specifically, *** 1
15553 21 CFR 111.260(j)(2)(i) Batch record - initials; weighing Your batch production records did not include the initials of the person responsible for weighing or measuring each component used in the batch.  Specifically, *** 1
15555 21 CFR 111.260(j)(2)(iii) Batch record - initials; component Your batch production records did not include the initials of the person responsible for adding a component to the batch.  Specifically, *** 1
15556 21 CFR 111.260(j)(2)(iv) Batch record - initials; verifying component  Your batch production records did not include initials of the person responsible for verifying the addition of components to the batch.  Specifically, *** 1
15557 21 CFR 111.260(k) Batch record - packaging, labeling Your batch production records did not include documentation, at the time of performance, of [packaging] [labeling] operations.  Specifically, *** 1
15567 21 CFR 111.260(l)(4) Batch record - approved, released, rejected   Your batch production records did not include documentation that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement.  Specifically, *** 1
15568 21 CFR 111.260(m) Batch record - performance Your batch production records did not include documentation [at the time of performance] of a required material review and disposition decision.  Specifically, *** 1
15570 21 CFR 111.153 Written procedures - components You did not [establish] [follow] written procedures for the requirements for components of dietary supplements.  Specifically, *** 1
15577 21 CFR 111.155(b) Visually examine - supplier's invoice You did not visually examine the supplier's invoice, guarantee, or certification in [a shipment] [shipments] you received to ensure the components are consistent with your purchase order.  Specifically, *** 1
15579 21 CFR 111.155(c)(1) Components - representative samples You did not collect representative samples of components while the components were quarantined.  Specifically, *** 1
15582 21 CFR 111.155(e) Components - contamination, deterioration, mix-ups You did not hold components under conditions that will [protect against contamination] [protect against deterioration] [avoid mix-ups].  Specifically, *** 1
15585 21 CFR 111.155(d)(2) Components - unique identifier  You did not use a unique identifier whenever you recorded the disposition of [each unique lot within each unique shipment of components that you received] [each lot of components that you produced].  Specifically, *** 1
15589 21 CFR 111.160(c) Packaging, labels - quarantine You did not quarantine [packaging] [labels] before you used them in the manufacture of a dietary supplement.  Specifically, *** 1
15599 21 CFR 111.160(d)(1) Labels - identify 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, ***

1
15613 21 CFR 111.165(e) Product received - mix-ups  You did not hold received product under conditions that will avoid mix-ups.  Specifically, *** 1
15617 21 CFR 111.180(a) Records - comp, package, labels, product received: Available You did not have records or copies of records required for [components] [packaging] [labels] [product received for packaging or labeling] readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, *** 1
15618 21 CFR 111.180(b)(1) Written procedures - components  You did not make and keep written procedures for fulfilling the requirements that apply to components of dietary supplements.  Specifically,  *** 1
15625 21 CFR 111.180(b)(3) Documentation - components  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, *** 1
15626 21 CFR 111.180(b)(3) Documentation - packaging  You did not make and keep documentation that the requirements that apply to production and process control for packaging received were met.  Specifically, *** 1
15633 21 CFR 111.180(b)(3)(ii)(C) Documentation - required operation; results  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, *** 1
15646 21 CFR 111.460(a)  Hold, identify - in-process material  You did not identify and hold in-process material under conditions that protect against mix-up, contamination, or deterioration.  Specifically, *** 1
15649 21 CFR 111.465(a)(1) Hold - reserve samples; ordinary storage  You did not hold reserve samples [under conditions consistent with product labels] [under ordinary storage conditions].  Specifically,  *** 1
15658 21 CFR 111.475(a) Records - holding, distribution:  readily available  You did not have records or copies of records required for your holding and distributing operations readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, *** 1
15675 21 CFR 111.315(b) Sampling plans; establish, follow You did not [establish] [follow] sampling plans for obtaining representative samples.  Specifically, *** 1
15680 21 CFR 111.315(d) Standard reference materials; criteria for selecting, QC Your laboratory control processes for use of criteria for selecting standard reference materials used in performing tests and examinations were not reviewed and approved by quality control personnel.  Specifically, *** 1
15689 21 CFR 111.315(b)(3)   Sampling plans; finished batches You did not [establish] [follow] sampling plans for obtaining representative samples of finished batches of dietary supplements.  Specifically,  *** 1
15696 21 CFR 111.315(e) Examination, testing; established criteria You did not [establish] [follow] laboratory control processes for use of test methods and examinations in accordance with established criteria.  Specifically, *** 1
15709 21 CFR 111.325(b)(2) Laboratory methodology followed You did not make and keep documentation that established laboratory methodology was followed.  Specifically, *** 1
15720 21 CFR 111.370 Rejected dietary supplements - identify, hold, control  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, 1
15742 21 CFR 111.210(h)(3) Specific actions; packaged, labeled 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, *** 1
15769 21 CFR 111.420(b)   Repackaged, relabeled - specifications  You did not examine a representative sample of each batch of [repackaged] [relabeled] dietary supplement to determine whether the established specifications were met.  Specifically, *** 1
15771 21 CFR 111.415(h)  Obsolete labels, packaging - dispose  You did not suitably dispose of labels and packaging for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future packaging and label operations.  Specifically, *** 1
15772 21 CFR 111.415(g)  Representative sample - packaged, labeled dietary supplement You did not examine a representative sample of each batch of packaged and labeled dietary supplement to determine whether the dietary supplement meets established specifications.  Specifically,  *** 1
15776 21 CFR 111.415(d)   Packaging, labeling - physical separation  You did not establish physical or spatial separation of [packaging] [label] operations from operations on other components and dietary supplements to prevent mix-ups.  Specifically, *** 1
15777 21 CFR 111.415(c) Filling, assembling, packaging, labeling - sanitary handling You did not use sanitary handling procedures during [filling] [assembling] [packaging] [labeling] operations.  Specifically, *** 1
15778 21 CFR 111.415(b)  Dietary supplement - protect, contamination  You did not protect manufactured dietary supplements from contamination during [filling] [assembling] [packaging] [labeling] operations.  Specifically, *** 1
15779 21 CFR 111.415(a)  Clean, sanitize - filling, packaging equipment  You did not clean and sanitize [filling and packaging equipment] [utensils] [dietary supplement packaging], as appropriate.  Specifically, *** 1
15781 21 CFR 111.415  Fill, assemble, package, label - quality  You did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a way that ensured the quality of the dietary supplement.  Specifically, *** 1
15802 21 CFR 111.560(c)  Product complaint - review, investigation  Your review and investigation of a product complaint did not extend to all relevant batches and records.  Specifically, *** 1
15803 21 CFR 111.560(c) Product complaint -investigate, findings, follow-up 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, *** 1
15808 21 CFR 111.570(a)   Records - product complaints:  readily available  You did not have records or copies of records required for product complaints readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, *** 1
15811 21 CFR 111.570(b)(2)(i)  Record - person document; time of performance The person who performed a requirement relating to product complaints did not document, at the time of performance, that the requirement was performed.   Specifically, *** 1
15813 21 CFR 111.570(b)(2)(ii)(B) Record - product complaint; batch, lot, control number  The written record of a product complaint did not include the batch, lot, or control number of the dietary supplement.  Specifically, *** 1
15814 21 CFR 111.570(b)(2)(ii)(C) Record - product complaint; date received, complainant The written record of a product complaint did not include [the date the complaint was received] [the name, address, or telephone number of the complainant].  Specifically, *** 1
15850 21 CFR 111.73  Specifications met  in-process purity, strength, composition You did not determine whether you met in-process specifications to ensure the [purity] [strength] [composition] of the dietary supplements.  Specifically, *** 1
15854 21 CFR 111.73 Specifications met - contamination limits  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, *** 1
15855 21 CFR 111.73   Specifications met - received product identified  You did not determine whether you met established specifications to provide sufficient assurance that product you receive from a supplier is adequately identified and is consistent with your purchase order.  Specifically, *** 1
15865 21 CFR 111.75(a)(2)(ii)(D) Re-confirm certificate of analysis  You did not periodically re-confirm the supplier's certificate of analysis for a component.  Specifically, *** 1
15866 21 CFR 111.75(a)(2)(ii)(E) Documentation - quality control, review, approve supplier  Your quality control personnel did not review and approve the documentation setting forth the basis for [qualification] [re-qualification] of a supplier of a component.  Specifically, *** 1
15874 21 CFR 111.75(c)(4) Documentation - specifications met; basis, quality control  Your quality control personnel did not review and approve your documentation of the basis for determining compliance with [an] established specification[s] for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement].  Specifically, *** 1
15886 21 CFR 111.77(b)  Specifications not met - identity; component, reject  Your quality control personnel did not reject a component that did not meet an identity specification.  Specifically,  *** 1
15887 21 CFR 111.77(c) Specifications not met - received product identified  Your quality control personnel did not reject a product that was not [adequately identified] [consistent with your purchase order].  Specifically, *** 1
15891 21 CFR 111.80(a) Components packaging, labels received You did not collect representative samples of each unique lot of [components] [packaging] [labels] that you received from a supplier to determine whether the [components] [packaging] [labels] meet[s] established specifications.  Specifically, *** 1
15894 21 CFR 111.80(d) Specifications - representative samples; unique lot  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, *** 1
15895 21 CFR 111.80(e)  Specifications - representative samples; packaged, labeled  You did not collect representative samples of each lot of [packaged] [labeled] dietary supplements to determine whether the [packaging] [labeling] of the finished dietary supplements meets established specifications.  Specifically, *** 1
15900 21 CFR 111.83(b)(2)  Reserve sample - batch, lot, control number  Your reserve sample of dietary supplement was not identified with the batch, lot, or control number.  Specifically, *** 1
15901 21 CFR 111.83(b)(3) Reserve sample - retained   You did not retain reserve samples for the required time.  Specifically, *** 1
15902 21 CFR 111.83(b)(4) Reserve sample - twice the quantity  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, *** 1
15908 21 CFR 111.90(b)(1) Reprocessed, dietary supplement - no material review  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, *** 1
15922 21 CFR 111.95(b)(3)   Documentation - ensure specifications met   You did not make and keep documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement].  Specifically, *** 1
15923 21 CFR 111.95(b)(4) Documentation - specifications met; test, examinations  You did not make and keep documentation for why the results of tests or examinations you selected for the product specifications ensure that the dietary supplement meets all product specifications.  Specifically, *** 1
15934 21 CFR 111.105(c)   Basis; in-process, component, specifications Your quality control personnel did not review and approve the documentation setting forth the basis for 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, *** 1
15940 21 CFR 111.105(h)   Quality control - production, process control Your quality control personnel did not determine that specifications established for the production and process control system were met.  Specifically, *** 1
15941 21 CFR 111.105(i)   QC required operations production and process control Your quality control personnel did not perform required operations for the production and process control system.  Specifically, *** 1
15945 21 CFR 111.105(i)   QC - required operations packaging/labeling operations Your quality control personnel did not perform required operations for [packaging] [labeling] operations. Specifically, *** 1
15947 21 CFR 111.105(i)   Quality control - required operations product complaints Your quality control personnel did not perform required operations for product complaints. Specifically, *** 1
15951 21 CFR 111.110(c)   Quality control operations - tests, examinations; results Your quality control operations did not include reviewing and approving the results of required [tests] [examinations].  Specifically, *** 1
15958 21 CFR 111.113(a)(5)   QC returned dietary supplement; material review, disposition Your quality control personnel did not conduct a material review and make a disposition decision when a dietary supplement was returned.  Specifically, *** 1
15972 21 CFR 111.120(b) QC operations -specifications; components, packaging, labels Your quality control operations did not include determining whether [components] [packaging] [labels] conform to established specifications.  Specifically,  *** 1
15973 21 CFR 111.120(c) QC operations - material review, disposition decision 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, *** 1
15977 21 CFR 111.123(a)(1)   QC operations - master manufacturing record, modifications Your quality control operations did not include reviewing and approving [master manufacturing records] [modifications to the master manufacturing records]. Specifically, *** 1
15980 21 CFR 111.123(a)(4) QC operations - material review, disposition decision Your quality control operations for [the master manufacturing record] [the batch production record] [manufacturing operations] did not include conducting a required material review and making a required disposition decision.  Specifically, *** 1
15982 21 CFR 111.123(a)(6)   Quality control operations - in-process specifications Your quality control operations did not include determining whether established in-process specifications were met.  Specifically, *** 1
15984 21 CFR 111.123(a)(8)   Quality control - finished batch, distribution Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution.  Specifically, *** 1
15985 21 CFR 111.123(b)(1)   Quality control - components, identity specifications Your quality control personnel approved and released for distribution a batch of dietary supplement for which one or more components did not meet identity specifications.  Specifically, *** 1
15986 21 CFR 111.123(b)(2)   Quality control - batch, product specifications Your quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications.  Specifically, *** 1
15989 21 CFR 111.127 Quality control operations - packaging, labeling You do not have quality control operations for [packaging] [labeling].  Specifically, *** 1
15994 21 CFR 111.127(c)   Quality control operations - packaging, labeling; records Your quality control operations did not include reviewing and approving all records for [packaging] [label] operations.  Specifically, *** 1
16000 21 CFR 111.130 Quality control operations - returned dietary supplement You do not have quality control operations for returned dietary supplements.  Specifically, *** 1
16007 21 CFR 111.135 Quality control operations - product complaints You do not have quality control operations for product complaints.  Specifically, *** 1
16012 21 CFR 111.140(a)   Records - quality control operations:  readily available You did not have records or copies of records required for your quality control operations readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, *** 1
16021 21 CFR 111.140(b)(3)(iii)     Records material review, disposition, follow-up; evaluation Your documentation of your material review and disposition decision and follow-up did not include an evaluation of whether or not the deviation or unanticipated occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement or a failure to package and label the dietary supplement as specified in the master manufacturing record.  Specifically, *** 1
16039 21 CFR 111.605(c)  Records - electronic  Your electronic records do not comply with the electronic records requirements.  Specifically,  *** 1
16048 21 CFR 111.515 Returned dietary supplement - destroyed  You did not destroy, or otherwise suitably dispose of, a returned dietary supplement not approved for salvaging and redistribution or not approved for reprocessing.  Specifically, *** 1
16052 21 CFR 111.530 Returned dietary supplement - investigation  You did not conduct an investigation of your manufacturing processes, and of each other batch implicated when a dietary supplement was returned, to determine compliance with specifications.  Specifically, *** 1
16054 21 CFR 111.535(a) Records-Rtn'd dietary supplement: originals, copies, elec You did not keep the records required for returned dietary supplements as original records, true copies, or as electronic records.  Specifically, *** 1
16056 21 CFR 111.535(a)   Records - returned dietary supplement:  readily available  You did not have  records or copies of  records required for returned dietary supplements readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, *** 1
16060 21 CFR 111.535(b)(4) Returned dietary supplement: reevaluation, determination You did not make and keep records [of documentation of the reevaluation by quality control personnel of a dietary supplement that was reprocessed] [of the determination by quality control personnel of whether the reprocessed dietary supplement met established product specifications].  Specifically, *** 1
16066 21 CFR 111.35(b)(1)(i)  Written procedures -  instruments, controls; calibrating  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, *** 1
16072 21 CFR 111.35(b)(3) Instruments, controls; calibrate date, reference std, method 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, *** 1
16083 21 CFR 111.35(b)(6)   Documentation - equipment functions; intended use  You did not make and keep documentation of the controls you use to ensure that equipment functions according to its intended use.  Specifically, *** 1
16087 21 CFR 111.123(b)(4) QC supplier product released assurance not provided  package Your quality control personnel approved and released for distribution product received from a supplier for [packaging] as a dietary supplement for which sufficient assurance was not provided [to adequately identify the product] [to determine that the product was consistent with your purchase order].  Specifically, *** 1
16091 FDCA 417(d)(1)(B) RFR - investigate cause You did not investigate the cause of the adulteration of a reportable food within 24 hours after you determined that the food was a reportable food.  Specifically, *** 1
16117 21 CFR 118.4 No written SE prevention plan Your firm does not have a written SE prevention plan that is specific to [each farm] [the farm] where you produce eggs.  Specifically,*** 1
16131 21 CFR 118.4(b) Transfer or introduction of SE You have not taken [adequate] steps to assure that there is no introduction or transfer of SE into or among poultry houses.  Specifically,*** 1
16133 21 CFR 118.4(b)(2) Cross contamination from equipment You do not maintain practices that will protect against cross contamination when equipment is moved among poultry houses.  Specifically,*** 1
16141 21 CFR 118.4(c)(2) Satisfactory fly control methods When your monitoring indicated unacceptable fly activity within a poultry house, appropriate methods were not used to achieve satisfactory fly control.  Specifically,*** 1
16142 21 CFR 118.4(c)(3) Removal of pest harborages 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,*** 1
16150 21 CFR 118.4(e) Eggs to be processed as table eggs 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,*** 1
16172 21 CFR 118.7(a) Plan appropriate to layout The poultry house environmental sampling plan was not appropriate to the poultry house layout. Specifically,*** 1
16183 21 CFR 118.9 Supervisor(s) training/job experience Supervisory personnel responsible for ensuring compliance with the SE prevention plan(s) [have not successfully completed training on SE prevention measures for egg production that is equivalent to that received under a standardized curriculum recognized by FDA] [lack qualification through appropriate job experience to administer the SE prevention measures].  Specifically,*** 1
16189 21 CFR 118.10(c) Records retention time All records are not retained for 1 year after the flock to which they pertain has been taken permanently out of production.  Specifically,***  1
16191 21 CFR 118.10(a)(2) Pullets records documentation  You do not maintain documentation [that pullets were "SE monitored" or were raised under "SE monitored" conditions] [that adequate environmental testing records for pullets were kept as required by CFR regulations].  Specifically,*** 1
16194 21 CFR 118.10(a)(3)(iii) Depopulation cleaning and disinfection procedures You did not maintain records documenting compliance with cleaning and disinfection procedures performed at depopulation. Specifically,***  1
16196 21 CFR 118.10(a)(3)(v) Sampling procedures documentation You did not maintain records documenting compliance with environmental and egg sampling procedures.  Specifically,*** 1
16204 21 CFR 118.10(b)(2) Date and time of activity All your required records do not include the [date] [time] of the activity that the records reflect.  Specifically,*** 1
16205 21 CFR 118.10(b)(3) Signatures or initials on operational records All required records do not have the signature or initials of the person performing the operation or creating the record.  Specifically,*** 1
16209 21 CFR 118.11(a) Registration within 30 days Your firm did not register your farm(s) with the FDA [within 30 days of becoming an egg producer] [by the applicable effective date of the regulation (21 CFR Part 118)].  Specifically,*** 1
16218 21 CFR 118.11(b)(2)(vi) Updating previously submitted info Registration information you submitted to FDA by mail or fax [was incorrect at the time of submission and was not immediately updated] [changed after submission and was not updated within 60 calendar days of the change(s)]. Specifically,*** 1
16286 21 CFR 113.87(c) Temperature-indicating device accuracy - initial temperature The temperature-indicating device used to determine the initial temperature of the product was not tested for accuracy [against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute standard reference device, by appropriate standard procedures] [with sufficient frequency to ensure that initial temperature measurements are accurate].  Specifically, *** 1
16296 21 CFR 113.100(c)(6) TID: accuracy record - date, results A record of the accuracy of a temperature-indicating device did not include the date on or before which the next accuracy test must be performed.  Specifically, *** 1
16304 21 CFR 113.100(d)(6) Reference Device: accuracy record - next test date The record of the accuracy of a reference device did not include the date on or before which the next accuracy test must be performed.  Specifically, *** 1
16307 21 CFR 113.40(a)(8) Still steam retorts: Bleeder not wide open during process A bleeder was not wide open during the entire process [including the come-up time].  Specifically, ***  1
16313 21 CFR 113.40(a)(1) RD accuracy test frequency A reference device was not tested for accuracy once a year or more frequently when necessary to ensure accuracy.  Specifically, *** 1
16352 21 CFR 113.40(b)(2)(iv) Still water retorts:Recorder-controller sensor:heating media The temperature recorder-controller sensor was not located where the recorded temperature was an accurate measurement of the scheduled process temperature [and was not affected by the heating media].  Specifically, *** 1
16459 21 CFR 113.40(g)(1)(i)(B) Aseptic processing: recorder, permanent record A temperature-recording device did not have a mechanism for recording temperatures to a permanent record.  Specifically, *** 1
16476 21 CFR 113.40(g)(1)(ii)(E) Aseptic processing: product flow rate, records, frequency The product flow rate was not [observed] [recorded] at intervals of sufficient frequency to ensure that these values were as specified in the scheduled process.  Specifically, *** 1
16489 21 CFR 113.40(j) Other systems: Methods, controls - scheduled process 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, *** 1
16497 FDCA 601(e) Unsafe color additive Your cosmetic is, bears, or contains an unsafe color additive.  Specifically, *** 1
16511 21 CFR 129.35(a)(3)(i) Sample frequency - operations water 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, *** 1
18155 21 CFR 117.80(a)(5)

Use of testing procedures You did not use testing procedures to identify [sanitation failures] [possible allergen cross-contact] [food contamination].  Specifically, *** 1
18157 21 CFR 117.80(b)(2)

Raw Materials Control - Treatment for Microorganisms You did not ensure that raw materials and other ingredients were not adulterated by pathogenic microorganisms.  Specifically, *** 1
18158 21 CFR 117.80(b)(5)

Identification Of Rework You did not identify materials scheduled for rework.  Specifically, *** 1
18162 21 CFR 117.80(c)

Process Control Measures You did not take an adequate measure to destroy or prevent the growth of undesirable microorganisms in your food.  Specifically, *** 1
18164 21 CFR 117.80(c)(9)

Adulterated Food Disposition You did not properly [dispose of] [recondition] adulterated food.  Specifically, *** 1
18166 21 CFR 117.95(a)

Human Food By-Products You did not hold a human food by-product intended for distribution as animal food under conditions that will protect against contamination.  Specifically, *** 1
18167 21 CFR 117.95(a)(3)

Human Food By-Product: Identifying as Animal food You did not accurately identify a human food by-product held for use as animal food.  Specifically, *** 1
18256 21 CFR 1.502(b)(1) LACF compliance 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, *** 1
18257 21 CFR 1.502(b)(1) LACF nonmicrobiological hazard For a low-acid canned food, your FSVP did not address all matters that are not controlled by the low-acid canned foods regulations.  Specifically, *** 1
18259 21 CFR 1.503(a) Qualified individual develop FSVP A qualified individual did not develop your FSVP.  Specifically, *** 1
18267 21 CFR 1.504(c)(1) Evaluation absence of control Your hazard analysis did not include an evaluation of an identified hazard to assess the probability that the hazard will occur in the absence of a control.  Specifically, *** 1
18271 21 CFR 1.504(d) Review entity's hazard analysis You did not [review] [assess] the hazard analysis conducted by another entity.  Specifically, *** 1
18288 21 CFR 1.505(d) Evaluation, reevaluation - another entity 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, *** 1
18291 21 CFR 1.506(a)(1) Procedures - establish unapproved supplier You did not establish written procedures for using an unapproved foreign supplier on a temporary basis.  Specifically, *** 1
18292 21 CFR 1.506(a)(2) Supplier approval - another entity You did not document your review and assessment of another entity's documentation of procedures and activities established to ensure that you import food only from foreign suppliers approved based on an evaluation of the risk posed by a food and foreign supplier's performance.  Specifically, *** 1
18296 21 CFR 1.506(d)(1)(i) Verification activity frequency 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, *** 1
18299 21 CFR 1.506(d)(1)(ii) Verification activity - appropriate You did not conduct an appropriate supplier verification activity.  Specifically, *** 1
18303 21 CFR 1.506(e)(1)

Verification activity before import, periodically 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, *** 1
18331 21 CFR 1.510(a)(2) Record - sign, date You did not [sign] [date] an FSVP record [upon initial completion] [upon modification].  Specifically, *** 1
18366 21 CFR 1.511(c)(1) No CGMPs - supplier approval, performance, risk You did not document the evaluation you conducted to determine [a foreign supplier's performance] [the risk posed by a food].  Specifically, *** 1
18388 21 CFR 1.511(c)(2)(i)

No CGMPs - approval procedures 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 food.  Specifically, *** 1
18392 21 CFR 1.511(c)(3) No CGMPs - verification activities, procedures You did not [establish] [follow] written procedures [adequate] for ensuring that appropriate foreign supplier verification activities were conducted for a food you import.  Specifically, *** 1
18400 21 CFR 117.315

Record Retention You did not retain records as required.  Specifically, *** 1
18541 21 CFR 1.507(a)(2)(i)

Disclosure - customer subject cGMP 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, *** 1
18572 21 CFR 1.512(b)(3)(i)

Very small importer assurances, supplier 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, *** 1
18641 21 CFR 118.10(a)(4) SE prevention plan corrective actions You did not maintain a record of the corrective actions taken under your SE prevention plan.  Specifically, *** 1
18683 21 CFR 106.20(i)

Toilet, hand washing facilities -  water, soap, dryers A toilet facility or hand washing facility did not include [hot and cold water] [soap or detergent] [single-service towels or air dryers].  Specifically, *** 1
18690 21 CFR 106.30(b)

Equipment, utensil - design: cleanable, intended use You did not ensure that an equipment or utensil was designed [to be easily cleanable] [to withstand the environment of the intended use].  Specifically, *** 1
18876 21 CFR 106.100(f)(4)

Record - date, time A record of cleaning, sanitizing, or maintenance did not show the [date] [time] of such cleaning, sanitizing, or maintenance.  Specifically, *** 1
19035 21 CFR 117.135(c)(1) Process Controls Procedures - Adequate Your process controls procedures did not include appropriate [parameters] [maximum/minimum values].  Specifically, *** 1
19038 21 CFR 117.145(c)(1) Process Controls Monitoring Records You did not have process controls monitoring records.  Specifically, *** 1
19040 21 CFR 117.150(a)(2) Process Controls Corrective Action Procedures - Content Your corrective action procedures for process controls were not adequate.  Specifically, *** 1
19041 21 CFR 117.150(b)(2) Corrective Action for Unanticipated Food Safety Problems You did not take an appropriate corrective action in response to an unanticipated food safety problem.  Specifically, *** 1
19044 21 CFR 117.165(b) Process Controls Verif Procedures: Establish Implement You did not [establish] [implement] adequate written process controls verification procedures.  Specifically, *** 1
19046 21 CFR 117.160(b) Process Controls Validation Requirements Your process controls validation [was not performed by or overseen by a preventive controls qualified individual] [was not performed when necessary] [was not based on scientific evidence].  Specifically, *** 1
19060 21 CFR 117.145(b) Sanitation Controls - Monitoring Frequency Your sanitation controls monitoring frequency was not adequate.  Specifically, *** 1
19063 21 CFR 117.150(a)(2) Sanitation Controls Corrective Action Procedures - Content Your corrective action procedures for sanitation controls were not adequate.  Specifically, *** 1
19084 21 CFR 117.305 Preventive controls records - general requirements Your preventive controls records did not meet general records requirements.  Specifically, *** 1
21037 21 CFR 112.30(b) Training records You did not establish and keep records that document personnel training, including [the date of training] [training topics] [persons trained].  Specifically, *** 1
21098 21 CFR 112.123(a) Equip & tools - cleanability 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, *** 1
21110 21 CFR 112.127(a)(1) Domestic animals excluded from buildings You did not exclude domesticated animals from fully-enclosed buildings where covered produce, food contact surfaces, or food-packing material is exposed.  Specifically, *** 1
21113 21 CFR 112.128(b) Pest exclusion from fully-enclosed buildings You did not take adequate measures to exclude pests from your fully-enclosed buildings.  Specifically, *** 1
21134 21 CFR 112.140(b) Records - equipment cleaning and sanitizing You did not establish and keep documentation of the date and method of cleaning and sanitizing of equipment.  Specifically, *** 1
21276 21 CFR 117.405(a)(1) Supply-Chain Program Establish and Implement You did not [establish] [implement] a written supply-chain program.  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
12277 21 CFR 1271.75(a)(1) Risk factors, clinical evidence Donors were not screened by a review of relevant medical records for [risk factors]  [clinical evidence] of communicable disease agents and diseases.  Specifically, *** 16
12336 21 CFR 1271.180(a) Procedures to meet core CTGP 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, *** 11
12416 21 CFR 1271.260(e) Storage temperatures recorded, maintained Storage temperatures of HCT/Ps were not [recorded] [maintained].  Specifically, *** 10
12433 21 CFR 1271.265(f) Return to inventory--procedures 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] [followed] [reviewed] [revised].  Specifically, *** 6
12213 21 CFR 1271.47(a) Donor eligibility procedures Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 5
12221 21 CFR 1271.47(a) Procedures for all steps Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 5
12310 21 CFR 1271.160(a) All core requirements covered in program 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, *** 5
12457 21 CFR 1271.320(a) Procedures re complaints Procedures for the [review] [evaluation] [documentation] [investigation] of complaints relating to core CGTP requirements were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 5
12229 21 CFR 1271.50(a) Determination based on screening and testing HCT/P donors were not determined to be eligible based on the results of donor screening and testing.  Specifically, *** 4
12230 21 CFR 1271.50(a) Responsible person to determine, document 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, *** 4
12419 21 CFR 1271.265(a) Evaluation--microorganisms, damage Incoming HCT/Ps were [not evaluated for the presence and significance of microorganisms] [not inspected for damage and contamination].  Specifically, *** 4
12431 21 CFR 1271.265(e) Procedures and release criteria Procedures including  release criteria for activities relating to  the [receipt] [shipment] [distribution] of HCT/Ps were not [established] [maintained] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 4
12283 21 CFR 1271.75(e) Abbreviated procedure  The abbreviated donor screening procedure [was used for donors who had no complete donor screening procedure in the previous six months] [did not determine and document changes in the donor's medical history that would make the donor ineligible].  Specifically, *** 3
12373 21 CFR 1271.200(d) Inspected routinely Equipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to maintenance schedules].  Specifically, *** 3
12435 21 CFR 1271.270(a) Records maintained concurrently Records were not maintained concurrently with the performance of each step.  Specifically, *** 3
12236 21 CFR 1271.55(a)(2) Eligibility statement--basis of determination 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, *** 2
12246 21 CFR 1271.55(d)(1)(iii) Documentation--determination, by whom, date 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, *** 2
12250 21 CFR 1271.55(d)(4) Ten year retention 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, *** 2
12272 21 CFR 1271.65(b)(2) Labeled re: biohazard, risks, test results 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, *** 2
12282 21 CFR 1271.75(d) Donors with risks not determined ineligible 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, *** 2
12290 21 CFR 1271.80(d)(1) Reactive tests--not determined ineligible Donors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible.  Specifically, *** 2
12325 21 CFR 1271.160(b)(6) Deviations--evaluation, cause, corrective action 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, ***  2
12364 21 CFR 1271.195(c) Monitoring-microorganisms where appropriate Environmental conditions were not monitored for microorganisms.  Specifically, *** 2
12387 21 CFR 1271.220(a) Causing contamination, increasing risks 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, *** 2
12399 21 CFR 1271.230(a) Process validation procedures 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, *** 2
12411 21 CFR 1271.260(a) Contamination, mix ups, improper release 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, *** 2
12443 21 CFR 1271.270(d) Retention time (10 year rules) 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, *** 2
12447 21 CFR 1271.290(b) Establishing a system 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, **** 2
12492 21 CFR 1271.85(a) Infection with communicable disease agents Donors were not tested for evidence of infection with communicable disease agents.  Specifically, *** 2
12225 21 CFR 1271.47(d) Departures: recording and justifying Departures from donor eligibility procedures relevant to preventing risks of communicable disease transmission were not [recorded] [justified].  Specifically, *** 1
12231 21 CFR 1271.50(b)(1) Donor screening standards 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, *** 1
12240 21 CFR 1271.55(b)(3) Name and address on summary The summary of records for HCT/Ps did not contain the [name] [address] of the establishment that made the donor-eligibility determination.  Specifically, *** 1
12241 21 CFR 1271.55(b)(4) Reasons for ineligibility on summary 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, *** 1
12242 21 CFR 1271.55(c) Name and personal info on accompanying records The accompanying records for HCT/Ps included [the donor's name] [personal information that might identify the donor].  Specifically, *** 1
12247 21 CFR 1271.55(d)(2) Accurate, indelible, legible Donor eligibility records are not [accurate] [indelible] [legible].  Specifically, *** 1
12248 21 CFR 1271.55(d)(2) Information, English or translated-authenticity Information on [the identity] [the relevant medical records] of donors of HCT/Ps were [not in English] [not retained and translated to English] [not accompanied by a statement of authenticity by the translator that specifically identifies the translated document].  Specifically, *** 1
12278 21 CFR 1271.75(a)(2)  Risks associated with xenotransplantation Donors were not screened by a review of relevant medical records for disease risks associated with xenotransplantation.  Specifically, *** 1
12287 21 CFR 1271.80(c) Kits not FDA approved, specifically labeled 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, ***  1
12301 21 CFR 1271.150(c)(1)(iii) Ensurane of compliance 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, *** 1
12322 21 CFR 1271.160(b)(4) Training of personnel The quality program has not ensured the proper training and education of personnel involved in core GTP activities.  Specifically, *** 1
12326 21 CFR 1271.160(c) Quality audits performed periodically Periodic quality audits of activities related to core CGTP requirements have not been performed.  Specifically, *** 1
12343 21 CFR 1271.190(a) State of repair Facilities were not maintained in a good state of repair.  Specifically, *** 1
12351 21 CFR 1271.190(d)(1) Procedures for cleaning, sanitation Procedures for facility cleaning and sanitation were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].  Specifically, *** 1
12359 21 CFR 1271.195(a)(3) Aseptic processing---cleaning, disinfecting Environmental controls do not provide for adequate [cleaning] [disinfecting] of [rooms] [equipment] to ensure aseptic processing.  Specifically, *** 1
12370 21 CFR 1271.200(c) Calibration procedures and schedules (general) The [procedures] [schedules] for the calibration of equipment used for [inspection] [measuring] [testing] were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 1
12371 21 CFR 1271.200(a) Cleaned, sanitized per established schedules Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained]  according to established schedules.  Specifically, *** 1
12375 21 CFR 1271.210(a) Use prior to verification  Supplies and reagents were used before they were verified to meet specifications designed to prevent the introduction, transmission, or spread of communicable disease.  Specifically, *** 1
12398 21 CFR 1271.230(a) Validation & approval--established procedures Processes with results which could not be fully verified by inspection and tests, were not validated and approved according to established procedures.  Specifically, *** 1
12400 21 CFR 1271.230(a) Documented, dated, signed The validation [activities] [results] were not [documented] [dated and signed by the individual(s) approving the validation].  Specifically, *** 1
12415 21 CFR 1271.260(e) Temperature limits Acceptable temperature limits were not established for the storage of HCT/Ps at each step of the manufacturing process to inhibit the growth of infectious agents.  Specifically, *** 1
12417 21 CFR 1271.260(e) Periodic review of temperatures Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.  Specifically, *** 1
12421 21 CFR 1271.265(a) Acceptance criteria designed to prevent CD  Incoming HCT/Ps were not [accepted] [rejected] [placed in quarantine] based on pre-established criteria designed to prevent communicable disease transmission.  Specifically, *** 1
12425 21 CFR 1271.265(c)(1) Release of HCT/Ps by responsible person A  responsible person did not [document] [date] the determination that an HCT/P is available for distribution.  Specifically, *** 1
12429 21 CFR 1271.265(d) Shipping conditions appropriate Appropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P.  Specifically, *** 1
12432 21 CFR 1271.265(e) Documentation elements for activities 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, *** 1
12474 21 CFR 1271.350(b)(2) Content of deviation reports HCT/P deviation reports did not include [descriptions of the deviation(s)] [information relevant to the event(s) and manufacture of the HCT/Ps involved] [follow-up actions that have or will be taken].  Specifically, *** 1
12479 21 CFR 1271.370(b)(4) Warnings on label HCT/Ps made available for distribution were not labeled with or accompanied by applicable warnings.  Specifically, *** 1
12493 21 CFR 1271.90(b) Eligibility not required--warning labels HCT/Ps for which the donor eligibility determination was not performed were not prominently labeled with the appropriate warning statements.  Specifically, *** 1
12494 21 CFR 1271.85(c) Reproductive cells or tissues Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not tested for communicable diseases of the genitourinary tract.  Specifically, *** 1
12496 21 CFR 1271.85(b)(2) SOP for release; reactive for CMV 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] [followed] [reviewed] [revised].  Specifically, *** 1
15025 21 CFR 1271.85(b)(2) Cytomegalovirus (CMV) Donors of viable, leukocyte-rich cells or tissue were not tested for evidence of infection due to cytomegalovirus (CMV).  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
7036 21 CFR 1250.67 Prevention of contamination 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, *** 37
6558 21 CFR 1250.30(d) Plumbing design, installation, maintenance Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils].  Specifically, *** 10
6560 21 CFR 1250.32(a) Contamination Not all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils].  Specifically, *** 6
6564 21 CFR 1250.33(a) Maintained in good repair Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are maintained in good repair.  Specifically, *** 6
6552 21 CFR 1250.28 Handling to avoid contamination Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid contamination.  Specifically, *** 5
6581 21 CFR 1250.38(b) Soap, sanitary towels, water Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water].  Specifically, *** 5
7032 21 CFR 1250.63 Prevention of the spread of communicable diseases Servicing area are not [provided with all necessary sanitary facilities] [operated] [maintained] as to prevent the spread of communicable diseases.  Specifically, ***  4
6565 21 CFR 1250.33(a) Adequate facilities for cleaning, bactericidal treatment 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, *** 3
6570 21 CFR 1250.33(c) Storage and handling after bactericidal treatment Failure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse.  Specifically, *** 3
6591 21 CFR 1250.42(a) Backflow protection A water system not protected against backflow.  Specifically, *** 3
7038 21 CFR 1250.67 Signs for non-potable water Outlets for non-potable water are not posted with [permanent] signs warning that the water is unfit for drinking.  Specifically, *** 3
7053 21 CFR 1250.75(b) Sanitary sewers or alternative methods Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal].  Specifically, *** 3
7090 21 CFR 1250.82(e) Backflow prevention - general Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment].  Specifically, *** 3
6508 21 CFR 1240.61(a) Not pasteurized Milk or milk product in final package form for direct human consumption has not been pasteurized or made from dairy ingredients that have all been pasteurized.  Specifically, *** 2
6563 21 CFR 1250.33(a) Easily cleaned, self-draining 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, *** 2
6569 21 CFR 1250.33(b) Equipment kept clean Failure to keep all equipment clean.  Specifically, *** 2
6579 21 CFR 1250.38(a) Suitable design and construction Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees.  Specifically, *** 2
6590 21 CFR 1250.42(a) Complete and closed A water system which is not [complete] [closed] from the filling ends to the discharge taps (except for protected vent openings).  Specifically, *** 2
6593 21 CFR 1250.42(b) Connections easily cleanable, located and protected Filling connections not [easily cleanable] [located and protected] so as to minimize the hazard of contamination of the water supply.  Specifically, *** 2
6609 21 CFR 1250.49 Clean and free of flies and mosquitoes Not all conveyances were kept [clean] [free of flies and mosquitoes] while in transit.  Specifically, *** 2
7041 21 CFR 1250.70(a) Adequate and readily accessible 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, *** 2
6525 21 CFR 1240.86 Lack of backflow prevention 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. 1
6549 21 CFR 1250.27 Storage of perishables Failure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared or kept hot for serving.  Specifically, *** 1
6554 21 CFR 1250.30(a) Ventilation and lighting Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated].  Specifically, *** 1
6555 21 CFR 1250.30(a) Clean and free from flies, rodents, and other vermin Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free from flies, rodents, and other vermin].  Specifically, *** 1
6561 21 CFR 1250.32(b) Clean hands Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment].  Specifically, *** 1
6568 21 CFR 1250.33(b) Cleaning of all other utensils Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] utensils (other than multiuse utensils) following the day's operation.  Specifically, *** 1
6572 21 CFR 1250.34 Thermometers Failure to equip each refrigerator with a thermometer located in the warmest region thereof.  Specifically, *** 1
6573 21 CFR 1250.34 Backflow protection for waste water drains Waste water drains from [ice boxes] [refrigerating equipment] [refrigerated spaces] are not so installed as to prevent backflow of contaminating liquids.  Specifically, *** 1
6584 21 CFR 1250.39 Containers - watertight, readily cleanable, non-absorbent Garbage containers are not [watertight] [readily cleanable] [non-absorbent].  Specifically, *** 1
7042 21 CFR 1250.70(a) Clean and sanitary Failure to maintain [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees in a clean and sanitary condition.  Specifically, *** 1
7051 21 CFR 1250.75(a) Contamination of passenger stations Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations].  Specifically, *** 1
7055 21 CFR 1250.75(b) Equipment for cleaning and flushing Equipment for [cleaning soil cans and removable containers] [flushing nonremovable containers and waste carts] is [not designed so as to prevent backflow into the water line] [used for a purpose connected with the handling of food, water, or ice].  Specifically, *** 1
7058 21 CFR 1250.79(a) Container construction Containers used to [receive] [store] garbage are not [water-tight] [readily cleanable] [nonabsorbent] [equipped with close-fitting covers].  Specifically, *** 1
7087 21 CFR 1250.82(c) Potable water tanks -- openings A potable water tank is equipped with a [manhole] [overflow] [vent] [device for measuring depth of water] and [no] [inadequate] provision is made to prevent entrance into the tank of contaminating substances.  Specifically, *** 1
7089 21 CFR 1250.82(d) Identification marks on tanks and piping Not all [tanks] [piping] bear clear marks of identification.  Specifically, *** 1
7091 21 CFR 1250.82(e) Backflow prevention - waste pipes Lack of backflow prevention for waste pipes discharging to a drain from the potable water system.  Specifically, *** 1
7092 21 CFR 1250.82(f) Cleaning, disinfecting, flushing Failure to [clean] [disinfect] [flush] a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases.  Specifically, *** 1
7112 21 CFR 1250.87 Labeling of faucets Systems for wash water do not meet the requirements of a potable water system, and not all faucets are labeled "Unfit for drinking."  Specifically, *** 1
7121 21 CFR 1250.96 Rodent infestation Failure to prevent, through generally accepted methods of control, an infestation by rodents.  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
5034 21 CFR 1010.2(c) Certification not based on adequate test/testing program Certification was not based upon [a test, in accordance with the standard] [a testing program in accordance with good manufacturing practices].  Specifically, *** 10
5007 21 CFR 1002.13 Failure to submit You did not submit an annual report [by the September 1 deadline] for products requiring one.  Specifically, *** 8
5008 21 CFR 1002.20(a) Failure to report 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, *** 3
5117 21 CFR 1030.10(c)(2)(vi) Means to monitor interlocks  A means of monitoring one or both of the required safety interlocks [was not provided] [did not cause the

oven to become inoperable and remain so until repaired when the required interlocks failed to perform required functions].  Specifically, ***
3
5012 21 CFR 1003.10(a) FDA not notified of defect or noncompliance  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, *** 2
5032 21 CFR 1010.2(b) Certification label or tag 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, *** 2
5044 21 CFR 1010.3(a)(2) ID label lacks place, month & year of manufacture An identification label fails to provide the [place] [month] [year] of manufacture.  Specifically, *** 2
5203 21 CFR 1040.10(h)(2)(i) Reproduction of affixed information 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, *** 2
5700 21 CFR 1002.10 Failure to submit, distinct marking 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, *** 2
5802 21 CFR 1002.13 Lack of required elements An annual report which you submitted did not [summarize the contents of the records required by 21 CFR 1002.30(a)] [provide the volume of products produced, sold, or installed] [cover the 12-month period ending on June 30 preceding the due date of the report]. Specifically, *** 2
5907 21 CFR 1020.30(d)(1) Report of assembly submitted within 15 days A completed  report of assembly regarding certified components installed in a diagnostic x-ray system was not submitted to [the Director, CDRH] [the purchaser] [the State agency responsible for radiation protection] within 15 days following the completion of the assembly.  Specifically, *** 2
5031 21 CFR 1010.2(a) Lack of certification of conformance 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, *** 1
5116 21 CFR 1030.10(c)(2)(v) Secondary safety interlock failure The designated  secondary safety interlock on a microwave oven failed to prevent microwave radiation emission in excess of 5 milliwatts per square centimeter, at any point 5 centimeters or more from the external surface of the oven. Specifically, *** 1
5122 21 CFR 1030.10(c)(3)(iii) Measurements with tap water container Microwave oven measurements were not made with the microwave oven [operating at maximum output] [containing a load of  275 ? 15 milliliters of  tap water initially at 20 ? 5 degrees centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer].  Specifically, *** 1
5197 21 CFR 1040.10(h)(1)(i) User information, adequate instructions 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, *** 1
5225 21 CFR 1040.20(d)(1)(iv) Recommended exposure schedule Each sunlamp product does not have a label containing the recommended exposure schedule, including [duration and spacing of sequential exposures] [maximum exposure time(s) in minutes].  Specifically, *** 1
5233 21 CFR 1040.20(d)(3)(ii) UV lamp labels permanent, legible Label(s) required by the standard on ultraviolet lamps are not permanently affixed or inscribed so as to be legible and readily accessible to view.  Specifically, *** 1
5236 21 CFR 1040.20(e)(1)(i) Reproduction of labels  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, *** 1
5244 21 CFR 1040.20(f) Test deficiencies The certification tests [did not account for all errors and statistical uncertainties in the process] [did not account for changes in radiation emission or degradation in radiation safety with the age of the product].  [Failure to make measurements for certification purposes under those operational conditions, lamp voltage, current, and position as recommended by the manufacturer.]  [Failure to position the measuring instrument at the recommended exposure position and so oriented as to result in  the maximum detection of the radiation by the instrument.]  Specifically, *** 1
5443 21 CFR 1020.30(g) Providing adequate assembly information Instructions for [assembly] [installation] [adjustment] [testing] of components adequate to assure that the product will comply with the regulations, when [assembled] [installed] [adjusted]  [tested] as directed, was not provided to [assemblers] [persons other than assemblers, upon request, at a cost not to exceed the cost of publication and distribution]  Specifically, ***



1
5475 21 CFR 1020.30(m)(1) Half-value layer--amount of filtration With reference to Table 1 appearing in Title 21 CFR 1020.30(m), the half-value layer (HVL) of the useful beam for a given x-ray tube potential was less than the appropriate value shown in table 1 [under "Specified dental systems" for the dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980] [under "Other X-ray systems" for all x-ray systems other than specified dental systems]. Specifically, *** 1
5479 21 CFR 1020.30(n) Compliance measurement 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, *** 1
5504 21 CFR 1020.31(c)(1) Independent mA selection For equipment having independent selection of x-ray tube current, the average ratios of exposure to the indicated milliampere-seconds product obtained at any two consecutive tube current settings differed by more than 0.10 times their sum.  Specifically, *** 1
5811 21 CFR 1002.30(a)(1) Quality control procedures You have not [established] [maintained] records containing a description of quality control procedures with respect to electronic product radiation safety.  Specifically, *** 1
5812 21 CFR 1002.30(a)(2) Results of tests 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, *** 1
5813 21 CFR 1002.30(a)(2) Methods, devices, procedures for testing You have not [established] [maintained] records of the [methods] [devices] [procedures] used in tests for electronic product radiation safety.  Specifically, *** 1
5814 21 CFR 1002.30(a)(2) Basis for selecting methods, devices, procedures You have not [established] [maintained] records of the basis for selecting the [methods] [devices] [procedures] used in tests for electronic product radiation safety.  Specifically, *** 1
5905 21 CFR 1020.30(d) Assembling, installing, adjusting, testing  The assembler did not [assemble] [install] [adjust] [test] certified component(s) in a diagnostic x-ray system according to the manufacturer's instructions.  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
4185 FDCA 402(a)(4) Record keeping Treatment records were not [maintained] [complete].  Specifically,***  139
4093 21 CFR 530.11(d) Tissue residue 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, *** 117
1360 FDCA 501(a)(5) Expired drugs Expired drug(s) were observed in the drug storage area.  Specifically, *** 37
7001 FDCA 402(a)(4) Drug inventory You lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock].  Specifically, *** 37
13509 FDCA 402(a)(4) Identity of animals 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, *** 27
4182 FDCA 501(a)(5) Extra label use w/o veterinary client-patient relationship Use of [a human] [an animal] drug in a manner contrary to label directions without benefit of a valid veterinary client-patient relationship.  Specifically, *** 25
13521 21 CFR 530.41(a) Drugs prohibited for extralabel use in food producing animal A prohibited [drug] [substance] was administered in an extralabel manner to [a] food-producing animal(s).  Specifically, ***





25
4097 21 CFR 530.20(a)(2)(iv) Tissue residue 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, *** 18
4298 21 CFR 530.11(a) Rx not followed 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, *** 18
1366 21 CFR 530.11(a) Dosage level Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship.  Specifically, *** 15
4186 FDCA 402(a)(4) System for administration of drugs Failure to have a system to control administration of drug treatments to your animals.  Specifically, *** 15
1442 FDCA 402(a)(4) Records review prior to slaughter 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, *** 12
1362 21 CFR 530.11(a) Species or class 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, *** 11
1389 21 CFR 530.11(a) Withdrawal period 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, *** 11
4545 21 CFR 225.120 Vermin and pest infestation Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation.  Specifically, *** 11
1446 FDCA 402(a)(4) Hospital pen Failure to [identify] [segregate] [quarantine] treated animals.  Specifically, *** 10
13508 FDCA 402(a)(4) Medication status of animals  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, *** 10
1373 21 CFR 530.11(a) Route of administration 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, *** 7
1811 21 CFR 225.58(b)(1) Three assays per year 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, *** 6
4184 FDCA 501(a)(5) Conditions of use Administration of a drug for conditions not [specified in its labeling] [prescribed].  Specifically, *** 6
18206 21 CFR 507.19(e)

Pest Control You did not take effective measures to [exclude pests from your plant] [protect against contamination of animal food by pests].  Specifically, *** 6
1469 21 CFR 225.20(b)(3) Pest access minimized The building is not constructed to minimize access by [rodents] [birds] [insects] [pests].  Specifically, *** 5
1744 21 CFR 225.42(b)(6) Daily inventory record kept Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds.  Specifically, *** 5
4560 21 CFR 225.165 Establishment and use of adequate procedures 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, *** 5
1457 FDCA 402(a)(4) Feeding colostrum Feeding colostrum or milk from treated cows to calves intended for slaughter.  Specifically, *** 4
1923 21 CFR 225.65(b) Reasonable and effective procedures followed 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, *** 4
18201 21 CFR 507.19(a)

Plant Maintenance You did not maintain your plant [in a clean manner] [in good repair] to prevent animal food from becoming adulterated.  Specifically, *** 4
1760 21 CFR 225.42(b)(6) Lot number or shipment I.D. number The daily inventory records for drugs do not include [the manufacturer's lot number] [the feed manufacturer's shipment identification number].  Specifically, *** 3
2097 21 CFR 225.102(b)(4) Daily review of production records 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, ***

3
4132 21 CFR 589.2000(d)(1) Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants."  Specifically, *** 3
4547 21 CFR 225.130 Cleanliness, inspection, cleanout  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, *** 3
4552 21 CFR 225.142 Adequate procedures for Type A and Type B articles 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, *** 3
4564 21 CFR 225.180 Bagged or bulk deliveries All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that the feed can be properly used.  Specifically, *** 3
13541 FDCA 501(a)(5) Use of veterinary prescription drugs without a prescription Administration of veterinary prescription drugs was performed without the lawful written or oral order of a licensed veterinarian. Specifically, *** 3
1466 21 CFR 225.20(b)(2) Maintained in clean and orderly condition Buildings are not maintained in a reasonably clean and orderly manner.  Specifically, *** 2
1482 21 CFR 225.30(b)(1) Capability to produce a medicated feed Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity].  Specifically, *** 2
1821 21 CFR 225.58(b)(1) First batch assay No assay was performed on the first ever produced medicated feed batch of a medicated feed requiring a medicated feed license.  Specifically, *** 2
2098 21 CFR 225.102(b)(4) Discrepancies investigated, reported 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, ***



2
4100 21 CFR 530.20(a)(2)(iii) Identity of treated animals 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, *** 2
4111 21 CFR 530.12(c) Directions for use 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, *** 2
4548 21 CFR 225.130 Scales and metering devices The [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision] [accuracy] for their intended purpose.  Specifically, *** 2
18199 21 CFR 507.17(b)

Plant Construction and Design Your plant is not constructed or designed to facilitate cleaning, maintenance and pest control to reduce the potential for contamination.  Specifically, *** 2
18202 21 CFR 507.19(b)

Sanitation You did not [clean] [maintain] [store] utensils and equipment in a manner that protects against contamination.  Specifically, *** 2
1262 21 CFR 225.10(b)(2) Evaluation and supervision of employees Failure to provide an on-going program of evaluation and supervision of employees in the manufacture of medicated feeds.  Specifically, *** 1
1376 21 CFR 530.11(a) Frequency and duration Administration of an approved animal drug [more frequently] [for a longer time period] than specified in the labeling, without benefit of a valid veterinarian-client-patient relationship.  Specifically, *** 1
1493 21 CFR 225.30(b)(4) Calibration of scales and metering devices 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, *** 1
1634 21 CFR 225.42(b)(5) Receipt for each lot of drug received Failure to [prepare] [maintain] a receipt record for each lot of drug received.  Specifically, *** 1
1638 21 CFR 225.42(b)(5) Elements of receipt record 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, *** 1
1765 21 CFR 225.42(b)(6) Information required Daily Inventory records for each drug used do not include [the quantity of drug on hand at the beginning and end of the work day][the amount of each drug used, sold, or otherwise disposed of][the batches or production runs of medicated feed in which each drug was used][information concerning any semiprocessed intermediate mix to be used in a medicated feed][the action taken to reconcile any discrepancies in the inventory record].  Specifically, ***   1
1782 21 CFR 225.42(b)(7) Daily comparison, actual vs theoretical A daily comparison is not made between the actual amount of drug used and the theoretical amount of drug to be used in terms of the [semiprocessed] [intermediate] [finished] medicated feeds manufactured.  Specifically, *** 1
1792 21 CFR 225.42(b)(7) Discrepancies Failure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage and theoretical drug usage.  Specifically, *** 1
1835 21 CFR 225.58(c) Assay results kept one year Failure to maintain on the premises, originals or copies of all results of assays [including those from State feed control officials or any other governmental agency] for a period of not less than one year after distribution of the medicated feed.  Specifically, *** 1
1880 21 CFR 225.58(e) Distribution discontinued Distribution of a medicated feed which failed to meet its labeled drug potency was not discontinued.  Specifically, *** 1
1953 21 CFR 225.80(b)(2) Maintaining proofread label 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, *** 1
2074 21 CFR 225.102(a) Lack of MRF Failure to have a  Master Record File for manufacturing a specific product, which provides the complete procedure for manufacturing a specific product.  Specifically, *** 1
2075 21 CFR 225.102(b)(1) Preparation of MRF 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, ***

1
2076 21 CFR 225.102(b)(1) Elements of the MRF 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, *** 1
2093 21 CFR 225.102(b)(2) Elements of production record(s) 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, *** 1
2381 21 CFR 226.40(g) Discontinuing distribution Production and control procedures do not include provisions for discontinuing distribution of any Type A medicated article found by assay procedures or other controls to fail to conform to appropriate specifications.  Specifically, *** 1
4099 21 CFR 530.20(a)(2)(ii) Extended withdrawal period 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, *** 1
4101 21 CFR 530.20(a)(1) Approved drug available Failure to determine that an approved animal drug was clinically ineffective for its intended use in a food-producing animal, prior to prescribing or dispensing an approved human or animal drug contrary to the drug's labeling.  Specifically, *** 1
4135 21 CFR 589.2000(c)(1)(ii) Records maintained and available for inspection Failure to [maintain] [make available for inspection and copying] those records required to track those materials being rendered for feed use throughout their receipt, processing and distribution.  Specifically, *** 1
4144 21 CFR 589.2000(e)(1) Separate equipment and facilities Failure to maintain separate [equipment] [facilities] for the manufacture, processing, or blending of protein derived from mammalian tissues, to avoid commingling with or cross-contamination of products containing non-mammalian protein.  Specifically, *** 1
4157 21 CFR 225.42(b)(7) Detention of feeds with yield discrepancies Medicated feeds implicated in drug inventory discrepancies based on a comparison of actual vs. theoretical usage are not detained until the discrepancies have been reconciled.  Specifically, *** 1
4453 21 CFR 225.10(b)(1) Employees lack understanding All employees involved in the manufacture of medicated feeds do not have an understanding of the [manufacturing or control operations they perform] [location and proper use of equipment].  Specifically, *** 1
4541 21 CFR 225.42(b) Adequate procedures established 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, *** 1
4544 21 CFR 225.120 Buildings--space and access Buildings for the production of medicated feed lack adequate space for [equipment] [processing] [orderly receipt and storage of medicated feed] [access to equipment for routine maintenance and cleaning].  Specifically, *** 1
4550 21 CFR 225.135 Physical separation of areas The [work areas] [equipment] for the production or storage of [medicated feeds] [components] are [used for] [not physically separated from] the manufacture and storage of [fertilizers] [herbicides] [insecticides] [fungicides] [rodenticides] [pesticides].  Specifically, *** 1
4553 21 CFR 225.142 Packaged Type A and Type B designated areas The [packaged Type A medicated articles] [packaged Type B medicated feed] are not [stored in designated areas] [stored in their original closed containers].  Specifically, *** 1
4554 21 CFR 225.142 Bulk Type A and Type B storage Bulk [Type A medicated articles] [Type B medicated feeds] are not identified and stored in a manner such that their identity, strength, quality and purity will be maintained.  Specifically, ***  1
4555 21 CFR 225.142 Use in accord with directions All [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled mixing directions.  Specifically, *** 1
4557 21 CFR 225.158 Investigation and corrective action 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, *** 1
4558 21 CFR 225.158 Records kept for one year Records of [investigation] [corrective action] with respect to assays of drug components not meeting permissible levels are not maintained on the premises for a period of one year.  Specifically, *** 1
4562 21 CFR 225.180 Assuring correct labels are used Labels are not [received] [handled] [stored] in a manner that [prevents label mix-ups] [assures that the correct labels are used for the medicated feed].  Specifically, *** 1
4566 21 CFR 225.202 Elements of records Formula, production and distribution records are not maintained identifying the [formulation] [date of mixing] [date of shipment (if not for own use)].  Specifically, *** 1
4567 21 CFR 225.202 Facilitation of recall The [formula] [production] [distribution] records are not adequate to facilitate the recall of specific batches of medicated feed that have been distributed.  Specifically, ***  1
13564 21 CFR 589.2001(c)(2)(i) Exclude entire carcass not inspected and passed  Failure to exclude from use in animal food the entire carcass of cattle not inspected and passed for human consumption when the brain and spinal cord are not effectively removed and such cattle are 30 months of age or older.  Specifically,*** 1
13565 21 CFR 589.2001(c)(2)(ii) Renderer's maintaining adequate written procedures Failure to maintain adequate written procedures specifying how the process of [removing the brain and spinal cord from cattle not inspected and passed for human consumption] [separating animals based on whether or not they are 30 months of age or older] is carried out.  Specifically,*** 1
13567 21 CFR 589.2001(c)(2)(iv) Label "Do not feed to animals" Failure to conspicuously label [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with the statement "Do not feed to animals".  Specifically,*** 1
13568 21 CFR 589.2001(c)(2)(v) Marking with readily detected agent Failure to mark [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with an agent that can be readily detected on visual inspection.  Specifically,*** 1
13569 21 CFR 589.2001(c)(2)(vi) Tracking records: establish, maintain, make available Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are sufficient to track cattle materials prohibited in animal feed to ensure such material is not introduced into animal feed.  Specifically,*** 1
18198 21 CFR 507.17(a)

Grounds You did not keep the grounds around your animal food plant in a condition that would protect against the contamination of animal food.  Specifically, *** 1
18212 21 CFR 507.22(a)(4)

Animal Food Contact Surfaces Animal food contact surfaces are not [made of appropriate materials] [maintained] to protect animal food from being contaminated.  Specifically, *** 1
18213 21 CFR 507.22(b)

Processing Systems Your processing system is not [designed] [constructed] [maintained] in a way that protects against the contamination of animal food.  Specifically, *** 1
18217 21 CFR 507.25(a)

Plant Operations 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, *** 1
18219 21 CFR 507.25(b)(1)

Raw Material Controls 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, *** 1
18222 21 CFR 507.25(c)(1) Manufacturing, Processing, Packing, Holding Operations You did not maintain animal food under conditions that will minimize the potential for growth of undesirable microorganisms during manufacturing, processing, packing, and holding.  Specifically, *** 1
18240 21 CFR 507.202(a)

Record Requirements Your records are not [original] [actual values and observations obtained during monitoring and verification activities] [accurate, indelible and legible] [created concurrently with performance of the activity documented] [detailed to provide history of work performed].  Specifically, *** 1

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