Inspections, Compliance, Enforcement, and Criminal Investigations

FY 2016 Inspectional Observation Summaries

Number of 483s Issued from the System*

Inspections ending between 10/1/2015 and 9/30/2016

 
Center Name 483s Issued
Biologics 84
Bioresearch Monitoring 215
Devices 934
Drugs 691
Foods 2196
Human Tissue for Transplantation 92
Parts 1240 and 1250 97
Radiological Health 32
Veterinary Medicine 281
Sum Product Area 483s from System* 4622
Actual Total in System 483s** 4528
 
 

* 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, *** 39
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, *** 14
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,***



 
12
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, *** 12
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, *** 10
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, *** 8
155 21 CFR 606.160(b) Required records Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records.  Specifically, *** 5
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, *** 5
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, ***

 
4
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, *** 4
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, *** 4
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
9089 21 CFR 600.14(c) When to report Biological product deviations [were] [are] not reported within the 45 calendar day timeframe. Specifically, ***  4
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, *** 3
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, *** 3
159 21 CFR 606.160(a)(1) Legibility and indelibility Records are [illegible] [not indelible].  Specifically, *** 3
238 21 CFR 640.11(a) General requirements - storage Failure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing.  Specifically, *** 3
9044 21CFR 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, *** 3
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, *** 3
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,  3
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, *** 3
84 21 CFR 606.100(b)(5) Accurate measurement of quantity of blood The standard operating procedure fails to include a written description of the blood collection procedure, including in-process precautions taken to measure accurately the quantity of blood removed from the donor.  Specifically, *** 2
92 21 CFR 606.100(b)(13) Procedures to relate blood from donor to final disposition The standard operating procedure fails to include a written description of the procedures used for relating a unit of blood or blood component from the donor to its final disposition.  Specifically, *** 2
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, *** 2
165 21 CFR 606.170(a) Adverse reaction - Maintenance of Reports Failure to maintain reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of [blood collection] [transfusion]. Specifically, *** 2
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, *** 2
9078 21 CFR 600.12(a) Maintenance  - tracing Records are not maintained in a manner which allows steps in the [manufacture] [distribution] of product to be traced.  Specifically, *** 2
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, *** 1
35 21 CFR 606.40 Clean & orderly Failure to maintain facilities in a clean and orderly manner.  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
95 21 CFR 606.100(b)(16) Labeling procedures to avoid labeling mix-ups The standard operating procedure fails to [include a written description of the labeling procedures] [include safeguards to avoid labeling mix-ups].  Specifically, *** 1
100 21 CFR 606.110(b) Center approval for collection of rare antibodies The plasmapheresis of donor(s) whose blood contained rare antibodies but did not meet the donor requirements for [donor eligibility] [collection] [plasmapheresis] was performed without the prior approval of the Director, Center for Biologics Evaluation and Research.  Specifically, *** 1
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, *** 1
114 21 CFR 606.121(c)(1) Proper name of product The container label fails to include the [proper name] [modifier(s)] [attribute(s)] of the product in a prominent position. Specifically, *** 1
121 21 CFR 606.121(c)(2) Name, address, unique facility identifier The container label fails to include the [name] [address] [unique facility identifier] [license number of each manufacturer, for a licensed product].  Specifically, *** 1
123 21 CFR 606.121(c)(4)(i) Expiration date The container label fails to include the [expiration date, including the day, month, and year] [hour of expiration, for product less than 72 hours expiration, including product prepared in a system that might compromise sterility].  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
157 21 CFR 606.160(d) Retention period Failure to retain records [for 10 years after the  records of processing have been completed] [for 6 months after the latest expiration date for the individual product] [indefinitely where there is no expiration date].  Specifically, *** 1
166 21 CFR 606.170(a) Adverse reaction - Disposition of Reports Written reports of a product at fault in causing a transfusion reaction are not [forwarded to] [maintained by] the [manufacturer] [collecting facility].  Specifically, *** 1
167 21 CFR 606.170(b) Adverse reaction - fatality A confirmed, fatal complication of [blood collection] [transfusion] was not [reported as soon as possible] [submitted in writing within 7 days after the fatality] to the Director, Office of Compliance, Center for Biologics Evaluation and Research by the [collecting facility in the event of a donor reaction] [facility that performed the compatibility tests in the event of a transfusion reaction].  Specifically, *** 1
205 21 CFR 640.3(f) Donations in less than eight weeks A person served as a source of blood more than once in 8 weeks and was not examined at the time of donation and certified by a physician to be in good health as indicated in part in 21 CFR 640.3(b).  Specifically, *** 1
208 21 CFR 640.3(a)(1) Donor suitability procedures not followed  Failure to [follow] [maintain] [have available to personnel in the areas where procedures are performed] standard procedures and methods for determining the suitability of a donor as a source of blood.  Specifically, *** 1
300 21 CFR 640.67 Laboratory tests Failure to test each unit of Source Plasma for evidence of infection due to relevant transfusion-transmitted infections.  Specifically, *** 1
318 21 CFR 640.63(c)(3) Blood hemoglobin Each donor was not in good health on the day of donation, as indicated in part by a blood hemoglobin level of less than 12.5 grams per 100 milliliters of blood or 38% hematocrit.  Specifically, *** 1
320 21 CFR 640.63(c)(5) Serum protein Each donor was not in good health on the day of donation, as indicated in part by a total [serum] [plasma] protein of less than 6.0 grams per 100 milliliters of blood.  Specifically, *** 1
324 21 CFR 640.63(c)(9) Transmissible blood disease Each donor was not in good health on the day of donation, as indicated in part by a history and examination indicative of disease transmissible by blood transfusion (other than malaria).  Specifically, *** 1
335 21 CFR 640.65(b)(1)(i) Serological test Failure to draw from each donor [on the day of the first medical exam or plasmapheresis] [at least every 4 months after the day of the first medical exam or plasmapheresis] a sample of blood tested for [syphilis] [total plasma or serum protein determination] [serum protein electrophoresis or equivalent test].  Specifically, *** 1
368 21 CFR 640.72(d) Donor reaction Failure of the donor record to contain a full explanation of a donor reaction, while on the plasmapheresis premises or reported to the center after the donor has left the premises, including the measures taken to assist the donor and the outcome of the incident.  Specifically, *** 1
371 21 CFR 640.72(a)(3) Donor consent Failure to maintain the original or a clear copy or other durable record of the donor's written consent for participation in the plasmapheresis program or for immunization.  Specifically, *** 1
3245 21 CFR 640.61 Explanation of hazards Failure of a qualified physician to explain to the prospective Source Plasma donor the [hazards of the plasmapheresis procedure] [risks of a hemolytic transfusion reaction] [hazards involved if the donor was hyperimmunized].  Specifically, *** 1
3248 21 CFR 640.63(a) Determining donor suitability Failure to have donor suitability determined [by a qualified licensed physician or trained persons under his supervision].  Specifically, *** 1
3252 21 CFR 640.63(a) Determination not made on day of collection Determination of the suitability of Source Plasma donors was not made on the day of collection.  Specifically, *** 1
9050 21 CFR 600.11(a) Work areas  The [manufacturing] [storage] areas are not kept [clean] [ventilated] [orderly] [free from dust, dirt, vermin and other objects not required for manufacturing].  Specifically, *** 1
9052 21 CFR 600.11(b) Equipment  There is no assurance that equipment is [adequately sterilized] [properly cleaned] [inspected for cleanliness] [suitable for use].  Specifically, *** 1
9081 21 CFR 600.12(c) Sterilization of Equipment and Supplies Records relating to sterilization [equipment] [supplies] used in the in the processing of products are [incomplete] [not generated by means of automated recording devices] [not accurate] [not reliable] [not maintained in a manner that relates the record to the product].  Specifically, *** 1
9086 21 CFR 600.14(a)(1) Who must report - manufacturer Failure to submit [a] biological deviation [report] [reports].  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
9234 21 CFR 630.40(c) Notification w/in 8 weeks Failure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor was deferred or determined not to be eligible for donation.  Specifically, *** 1
9261 21 CFR 610.40(a) Test for HIV, HBV, HCV 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 [HIV]  [HBV] [HCV] .  Specifically, *** 1
9262 21 CFR 610.40(b) One or more approved screening tests Blood and blood components intended for transfusion or for use in manufacturing a product were not tested for evidence of infection due to relevant transfusion-transmitted infections [using one or more screening tests that the FDA has licensed, approved, or cleared for such use] [in accordance with the manufacturer's instructions].  Specifically, *** 1
9269 21 CFR 610.40(h) Shipment/use of reactive units, units from deferred donors Human blood or blood components that were [reactive by a screening test] [collected from a donor with a previous record of a reactive screening test] for evidence of relevant transfusion-transmitted infection were [shipped] [used] without meeting the exceptions set forth in the regulations.  Specifically, *** 1
9282 21 CFR 640.15(a) Accompanying unit Failure to provide one or more segments with each unit of [Whole Blood] [Red Blood Cells] when [issued] [reissued].  Specifically, *** 1
9424 21 CFR 680.1(b)(2)(iii) Maintained Written procedures [are not maintained] [do not ensure the identity of the seed culture] [do not prescribe adequate processing of the mold] [do not specify acceptable limits and kinds of contamination].  Specifically, *** 1
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, *** 1
15076 21 CFR 610.46(b)(3) Notify MD, Legal Rep, or Relative of Transf Recip [Consign] 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 HIV infection, of the need for recipient HIV testing and counseling.  Specifically, *** 1
18080 21 CFR 630.10(e) Medical History Interview Failure to conduct a medical history interview prior to collection of blood or blood components [to determine if the donor is in good health] [to identify risk factors closely associated with exposure to, or clinical evidence of, a relevant transfusion-transmitted infection] [to determine if there are other conditions that may adversely affect the health of the donor or the safety, purity, or potency or the blood or blood components or any product manufactured from the blood or blood components].  Specifically, *** 1
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, *** 1
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, *** 1
18132 21 CFR 640.21(e) Frequency of plateletpheresis Failure to prevent a plateletpheresis donor from donating at a frequency greater than allowed by the applicable regulations.  Specifically, ***  1
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, *** 1
Cite Id Ref No 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, *** 120
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, ***

 
70
7526 21 CFR 312.62(a) Accountability records Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects].  Specifically, ***

 
26
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, *** 20
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, *** 12
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, *** 12
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, *** 11
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
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, *** 9
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, *** 8
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, *** 7
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, *** 6
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, *** 6
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, *** 6
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, *** 6
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, *** 5
7479 21 CFR 312.56(a) Monitoring investigations Failure to monitor the progress of an investigation conducted under your IND.  Specifically, *** 5
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, ***



 
5
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, *** 4
7293 21 CFR 56.109(f) Continuing review The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of not less than once per year].  Specifically, *** 4
7319 21 CFR 56.115(a)(3) Records of continuing review Records have not been [prepared] [maintained] of all continuing review activities.  Specifically, *** 4
7321 21 CFR 56.110(c) Method to keep members advised The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for keeping members advised of research proposals which have been approved under the procedure.  Specifically, ***  4
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, *** 4
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, *** 4
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, *** 4
3955 21 CFR 58.63(b) Equipment: maintenance SOPs The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment are not adequate.  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
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, *** 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
7324 21 CFR 56.111(a)(4) Informed consent sought The IRB approved the conduct of research, but did not determine that informed consent would be sought from each prospective subject or the subject's legally authorized representative, to the extent required by 21 CFR 50.  Specifically, *** 3
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, *** 3
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, ***

 
3
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, *** 2
3957 21 CFR 58.81(a) SOPs: laboratory methods The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study.  Specifically, *** 2
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, *** 2
7279 21 CFR 56.107(f) Invited individual allowed to vote with IRB The IRB invited an individual with competence in a special area to assist in the review of complex issues which required expertise beyond or in addition to that available on the IRB; however, the IRB allowed the individual to vote with the IRB.  Specifically, *** 2
7286 21 CFR 56.108(b)(1) Prompt reporting of unanticipated problems The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any unanticipated problems involving risks to human subjects or others.  Specifically, *** 2
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, *** 2
7337 21 CFR 56.115(b) Retention of records Records required by 21 CFR 56 have not been maintained for three years following completion of the research.  Specifically, *** 2
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, *** 2
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, *** 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
7543 21 CFR 312.61 Unauthorized recipients (investigator) A study drug was [administered to subjects] [provided to persons] not under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator.   Specifically, ***

 
2
7628 21 CFR 312.57(b) Other financial interests of the investigator Failure to maintain [complete] [accurate] records of all financial interests of clinical investigators subject to financial interest reporting requirements.  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
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
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, *** 1
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, *** 1
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, *** 1
3948 21 CFR 58.47(a)(3) Facility: article mixture storage areas The testing facility does not provide separate areas, as necessary, to prevent contamination or mix-ups for storage of the test and control article mixtures.  Specifically, *** 1
3954 21 CFR 58.63(a) Equipment: calibration Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized.  Specifically, *** 1
3961 21 CFR 58.81(c) SOPs: availability Not all laboratory areas have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed.  Specifically, *** 1
3963 21 CFR 58.83 Reagents: labeling Not all reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and expiration date.  Specifically, *** 1
3988 21 CFR 58.105(d) Test article: reserve sample retention Not all reserve samples from each batch of test and control articles for studies of more than 4 weeks' duration were retained for the required period of time.  Specifically, *** 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
4002 21 CFR 58.120(a)(9) Protocol: tests, analyses, and measurements Not all protocols contained the type and frequency of tests, analyses, and measurements to be made.  Specifically, *** 1
4007 21 CFR 58.130(a) Conduct: in accordance with protocol Not all nonclinical laboratory studies were conducted in

accordance with the protocol.  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
4037 21 CFR 58.190(b) Archives: conditions of storage Conditions of storage failed to minimize deterioration of the [documents] [specimens] in accordance with the requirements for the time period of their retention and the nature of the [documents] [specimens].  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
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, *** 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
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, ***: 1
7298 21 CFR 56.109(a) Authority of the IRB The IRB does not have the authority to [approve] [require modifications in] [disapprove] all research activities covered by the regulations.  Specifically, *** 1
7317 21 CFR 56.115(a)(1) Copies of all research proposals and related documents Copies have not been [prepared] [maintained] of all [research proposals reviewed] [scientific evaluations, if any, accompanying research proposals] [approved sample consent documents] [progress reports submitted by investigators] [reports of injuries to subjects].  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
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, *** 1
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, *** 1
7339 21 CFR 56.108(a)(4) Changes in approved research The IRB [has no] [did not follow its] written procedure for ensuring that changes in approved research, during the periods for which IRB approval had already been given, would not be initiated without IRB review and approval (except where necessary to eliminate apparent immediate hazards to the human subjects).  Specifically, *** 1
7340 21 CFR 56.108(a)(3) Prompt reporting of changes The IRB [has no] [did not follow its] written procedure for ensuring prompt reporting to the IRB of changes in research activity.  Specifically, *** 1
7343 21 CFR 56.108(b)(3) Reporting  of suspension/termination The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval .  Specifically, *** 1
7367 21 CFR 50.55(e)(2) Two parents' permission: studies under Parts 50.53 - 50.54  For a clinical investigation involving children, conducted under [21 CFR 50.53] [21 CFR 50.54], the investigator did not always obtain the permission of both parents where feasible.  Specifically, *** 1
7368 21 CFR 56.108(a)(2) More frequent reviews, verification of no changes The IRB [has no] [did not follow its] written procedure for determining which projects [require review more often than annually] [need verification from sources other than the investigator that no material changes have occurred since previous IRB review] . Specifically, *** 1
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, *** 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
7381 21 CFR 50.27(b)(2) Short form: Summary copy not signed/given In a situation where a short form written consent document was prepared, a copy of the summary of what was to be said to the subject or the subject's legally authorized representative [was not signed by the witness] [was not signed by the person actually obtaining the consent] [was not given to the subject or the subject's legally authorized representative (in addition to a copy of the short form)].  Specifically, *** 1
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, *** 1
7392 21 CFR 50.25(a)(7) Whom to contact The informed consent document lacked an explanation of whom to contact [for answers to pertinent questions about the research and research subjects' rights] [in the event of a research-related injury to the subject].  Specifically, *** 1
7406 21 CFR 56.109(a) Scope of reviews The IRB does not review all research activities covered by the regulations.  Specifically, *** 1
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, *** 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
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
7461 21 CFR 312.58(a) FDA access to sponsor records Failure to permit FDA to [have access to] [review] [copy] records or reports related to a clinical investigation.  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
7499 21 CFR 312.64(a) Progress reports Not all investigational progress reports were furnished to the drug study sponsor.  Specifically, *** 1
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, ***

 
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
7546 21 CFR 312.64(d) Financial info update Updated financial information was not provided to the study sponsor when relevant changes occurred during [the course of the investigation] [the year following completion of the study].  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
7638 21 CFR 312.20(a) Failure to submit an IND The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,*** 1
7639 21 CFR 312.20(b) Starting a study before IND is in effect The sponsor began a clinical investigation subject to IND requirements before an IND was in effect.  Specifically,*** 1
7656 21 CFR 56.108(c) Approval from a majority of members present For other than expedited reviews, research approved by the IRB does not always receive the approval of a majority of those IRB members present.  Specifically, *** 1
7665 21 CFR 50.20 Exculpatory language, waiving of rights The general requirements for informed consent were not met in that the consent form contained exculpatory language [through which the subject or the subject's representative was made to waive or appear to waive some of the subject's legal rights] [that released or appeared to release the investigator, sponsor, the institution, or its agents from liability for negligence].  Specifically, *** 1
7666 21 CFR 50.20 Understandable language The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative.  Specifically, *** 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, *** 344
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,***  264
630 21 CFR 803.17 Lack of Written MDR Procedures Written MDR procedures have not been [developed] [maintained] [implemented].  Specifically, *** 146
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, ***  135
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, *** 122
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, *** 119
3696 21 CFR 820.100(b) Documentation Corrective and preventive action activities and/or results have not been [adequately] documented.  Specifically, ***   99
3103 21 CFR 820.30(i) Design changes - Lack of or Inadequate Procedures Procedures for design change have not been [adequately] established.  Specifically,*** 78
2327 21 CFR 820.22 Quality audits - Lack of or inadequate procedures  Procedures for quality audits have not been [adequately] established. Specifically, ***  76
3331 21 CFR 820.181 DMR - not or inadequately maintained  A device master record has not been [adequately] maintained.  Specifically, *** 65
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, *** 61
14712 21 CFR 820.184 DHR - not or inadequately maintained  A device history record has not been [adequately] maintained.  Specifically, *** 56
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, ***  53
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, ***  53
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, ***  52
3160 21 CFR 820.184 Lack of or inadequate DHR procedures  Procedures for device history records have not been [adequately] established.  Specifically,***  52
3168 21 CFR 820.198(a) Complaints  Complaint files are not [adequately] maintained.  Specifically, ***  47
3125 21 CFR 820.80(d) Lack of or inadequate final acceptance procedures  Procedures for finished device acceptance have not been [adequately] established. Specifically, ***  46
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].



 
46
3666 21 CFR 820.20(c) Management review - Lack of or inadequate procedures  Procedures for management review have not been [adequately] established.  Specifically,***  45
541 21 CFR 820.70(c) Environmental control  Lack of or inadequate procedures  Procedures to control environmental conditions have not been [adequately] established.  Specifically, *** 44
3101 21 CFR 820.30(g) Design validation- Lack of or inadequate procedures  Procedures for design validation have not been [adequately] established.  Specifically,***  44
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, *** 43
2371 21 CFR 820.30(a) Design control - no procedures  Procedures for design control have not been established.  Specifically,***  42
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, *** 36
14722 21 CFR 820.40 Procedures not adequately established or maintained Document control procedures have not been adequately [established] [maintained].  Specifically,***  36
3120 21 CFR 820.80(a) Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been [adequately] established.  Specifically,*** 35
3415 21 CFR 820.22 Quality Audit/Reaudit - conducted  Quality [audits] [reaudits] have not been performed.  Specifically, ***  32
3678 21 CFR 820.30(g) Design Validation - Risk analysis not performed/inadequate  Risk analysis [was not performed] [is inadequate] [is incomplete].  Specifically, ***  32
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, ***  30
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, *** 29
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].   29
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, *** 29
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, *** 27
3118 21 CFR 820.75(a) Documentation Process validation [activities] [results] have not been  [documented] [approved] [adequately documented] [adequately approved].  Specifically, *** 24
2604 21 CFR 820.30(e) Design review - Lack of or inadequate procedures  Procedures for design review have not been [adequately] established.  Specifically,***  23
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, *** 23
3837 21 CFR 820.25(b) Training records  Personnel training is not documented. Specifically, *** 23
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, ***  22
2650 21 CFR 820.30(f) Design verification - Lack of or inadequate procedures  Procedures for design verification have not been [adequately] established.  Specifically,***  22
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, ***  21
2302 21 CFR 820.20(e) Quality System Procedures Quality system procedures and instructions have not been established.  Specifically,***  21
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, *** 21
3128 21 CFR 820.90(a) Nonconforming product control Products that do not conform to specifications are not adequately controlled. Specifically, *** 21
3263 21 CFR 820.250(b) Sampling plans  Sampling plans are not [written] [based on valid statistical rationale].  Specifically, ***  21
3375 21 CFR 820.198(e) Records of complaint investigation  Records of complaint investigations do not include required information.  Specifically, ***  21
447 21 CFR 820.40 Lack of procedures, or not maintained   Document control procedures have not been [established] [maintained].  Specifically,***  20
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, *** 20
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, *** 19
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, *** 18
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, *** 18
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, ***  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
14720 21 CFR 820.50(a)(3) Acceptable supplier records, inadequate records  Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.  18
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, ***  17
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, ***  16
2557 21 CFR 820.30(c) Design input - documentation  Design input requirements were not [adequately] documented.   Specifically, *** 15
3102 21 CFR 820.30(h) Design transfer - Lack of or inadequate procedures   Procedures for design transfer have not been [adequately] established.  Specifically,*** 15
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,***  15
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, ***  15
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, ***  15
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, ***  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
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, *** 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
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, ***  13
3235 21 CFR 820.72(a) Equipment control activity documentation Equipment [calibrations] [inspections] [checks] [maintenance activities] have not been documented.  Specifically, *** 13
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, ***  13
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, ***  13
3132 21 CFR 820.120 Lack of or inadequate procedures for labeling  Procedures to control labeling activities have not been [adequately] established. Specifically, ***  12
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, *** 12
14718 21 CFR 820.30(g) Design validation - Risk analysis  Results of the design risk analysis were not [adequately] documented.  Specifically, *** 12
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, ***  11
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, *** 11
3671 21 CFR 820.25(a) Personnel  Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***  11
2328 21 CFR 820.22 Quality audits - auditor independence  Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***  10
3203 21 CFR 820.40(b) Document change records, maintained. Records of changes to documents were not [adequately] maintained.  Specifically, *** 10
3426 21 CFR 820.50(a)(1) Documented evaluation  The evaluation of potential [suppliers] [contractors] [consultants] was not documented.  Specifically, ***  10
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, *** 10
14715 21 CFR 820.30(d) Design output - Lack of or inadequate procedures  Procedures for design output have not been [adequately] established.  Specifically,*** 10
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, ***  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
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, ***  9
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, *** 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
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, *** 8
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, *** 8
658 21 CFR 803.30(a)(2) Report of Serious Injury Within 10 Days The user facility did not submit FDA Form 3500A or electronic equivalent to the [known device manufacturer] [FDA, because the device manufacturer was unknown,] within 10 working days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility.  Specifically, *** 8
2293 21 CFR 820.20(d) Quality plan A quality plan has not been [adequately] established.  Specifically, *** 8
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, ***



 
8
3674 21 CFR 820.30(d) Design output - documentation  Design output was not [adequately] documented before release.  Specifically, *** 8
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, ***  8
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,*** 8
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, *** 8
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,***  8
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, *** 7
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, *** 7
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, *** 7
3677 21 CFR 820.30(g) Design validation - software validation not performed  Validation of device software [was not performed] [is inadequate] [is incomplete].  Specifically, ***  7
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, *** 7
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, *** 6
640 21 CFR 803.18(a) Event files--failure to establish MDR event files have not been established and maintained.  Specifically, *** 6
656 21 CFR 803.30(a)(1) Report of Death  Within 10 Days The user facility did not submit FDA Form 3500A or electronic equivalent to [FDA] [the device manufacturer] within ten working days after becoming aware of information that reasonably suggests that a device has or may have caused or contributed to the death of a patient of the facility.  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, *** 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
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, ***  6
3668 21 CFR 820.20(c) Management review dates The results and/or dates of management reviews are not documented. Specifically, *** 6
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, ***  6
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,*** 6
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, *** 5
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, ***  5
3190 21 CFR 820.30(g) Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.  Specifically, *** 5
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, ***



 
5
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,*** 5
3409 21 CFR 820.200(d) Service reports   Service reports [are not documented] [do not include the required information].  Specifically, ***  5
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,*** 5
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, *** 4
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, ***  4
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, ***  4
3269 21 CFR 820.80(b) Incoming acceptance records, documentation  Acceptance or rejection of incoming product was not documented. Specifically, *** 4
3270 21 CFR 820.80(c) Documentation In-process inspections, tests, or other verification activities and approvals were not documented. 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
6800 21 CFR 807.20 Establishment not registered An establishment for which registration is required has not been registered.  Specifically, *** 4
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, ***  4
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, *** 3
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, *** 3
2969 21 CFR 812.100 No investigator protection - subject rights, safety, welfare The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected.  Specifically, *** 3
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
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, *** 3
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, *** 3
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, ***  3
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, ***  3
3139 21 CFR 820.140 Lack of or inadequate procedures for handling Procedures for product handling have not been [adequately] established.  Specifically,***



 
3
3193 21 CFR 820.30(g) Design validation - simulated testing The design was not validated under actual or simulated use conditions.  Specifically, ***  3
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, ***  3
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, ***  3
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, *** 3
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, *** 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
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, *** 3
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, *** 3
6802 21 CFR 807.21(a) Annual registration Your annual registration [is not current] [was not updated within 30 days of receipt of form FDA 2891a from FDA].   Specifically, *** 3
7012 21 CFR 812.100 Investigator lack of control of investigational devices Devices under investigation were not properly controlled.  Specifically, *** 3
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, *** 3
14717 21 CFR 820.30(g) Design validation - software validation documentation  Results of the validation of the device software were not [adequately] documented.  Specifically, *** 3
14719 21 CFR 820.30(h) Incorrect translation to production specifications The device design was not correctly translated into production specifications.  Specifically, ***  3
636 21 CFR 803.17(b)(2) Reports and information documentation The written MDR procedure does not include documentation and recordkeeping requirements for all Medical Device Reports and information submitted to [FDA] [device manufacturers].  Specifically, *** 2
648 21 CFR 803.18(e) MDR not  evaluated per 820.162 and 820.198 A submitted MDR event was not evaluated in accordance with the requirements of the regulations regarding [Failure Investigations] [Complaint Files].  Specifically, *** 2
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, *** 2
793 21 CFR 803.53(a) Firm Did Not Submit 5 Day Report A 5 day report was not submitted to FDA on Form 3500A within 5 workdays of becoming aware that a reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.  Specifically, *** 2
2339 21 CFR 820.22 Quality Audit/Reaudit - documentation   The dates of quality [audits] [reaudits] have not been documented.  Specifically, ***  2
2431 21 CFR 820.30(b) Design plans- updated  Design plans were not [reviewed] [updated] [approved] as design and development evolves.  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
2949 21 CFR 812.46(a) Sponsor securing investigator compliance An investigator was not complying with the [signed agreement] [investigational plan] [requirements of the regulations] [conditions of approval imposed by the IRB or FDA] and [compliance of the investigator was not promptly secured] [shipments of the investigational device to the investigator were not discontinued] [the investigator's participation in the investigation was not terminated].  Specifically, *** 2
2994 21 CFR 812.140(b)(3) Sponsor records of investigator agreements inadequate Signed investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current]. Specifically, *** 2
3147 21 CFR 820.170(a) Lack of or inadequate instructions [Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established.  Specifically,*** 2
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, ***  2
3175 21 CFR 820.186 QSR  The quality system record has not been [adequately] maintained.  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
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, *** 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
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.  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
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, ***  2
3372 21 CFR 820.198(d) Records of MDR Investigation  Investigation records of MDR reportable complaints do not include required information.  Specifically, ***  2
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, *** 2
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, *** 2
3838 21 CFR 820.40(a) Document review procedures, designated individual The document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance.  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
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, ***  2
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, *** 2
512 21 CFR 820.65 Traceability Lack of or inadequate {see also 820.120(e)}  Procedures for identifying with a control number each unit, lot, or batch of implantable or life supporting, life sustaining finished devices or appropriate components have not been [adequately] established.   Specifically, *** 1
621 21 CFR 803.11 Failure to use FDA Form 3500A An MDR adverse event report was submitted on a form other than FDA Form 3500A (MEDWATCH form) or an approved electronic equivalent.  Specifically, *** 1
638 21 CFR 803.17(b)(4) Info which facilitates timely FDA follow-up   The written MDR procedure does not include documentation and recordkeeping requirements for systems that ensure access to information that facilitates timely follow-up and inspection by FDA.  Specifically, *** 1
645 21 CFR 803.18(b)(2) FDA access not permitted An authorized FDA employee was not permitted to [access] [copy] [verify] MDR required records during reasonable times.  Specifically, ***   1
661 21 CFR 803.32 Reporting All Information Reasonably Known The user facility report submitted on FDA Form 3500A did not include all information reasonably known.  Specifically, *** 1
771 21 CFR 803.52(e)(1) Contact Office Name and Address An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block G the [contact office name and address] [device manufacturing site].  Specifically, *** 1
2916 21 CFR 812.7(d) Investigational device represented as safe and /or effective An investigational device was represented as being [safe] [effective] for the purposes for which it [is] [was] being investigated. Specifically, *** 1
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, *** 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
2973 21 CFR 812.110(a) Subject participation prior to study approval Subjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, *** 1
2976 21 CFR 812.110(c) Supply of investigational device to unauthorized person An investigational device was supplied to a person not authorized to receive it. Specifically, *** 1
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, *** 1
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, *** 1
2992 21 CFR 812.140(b)(2) Sponsor device shipment records inadequate Records of shipment of an investigational device that include the [name and address of the consignee] [type and quantity of device] [date of shipment] [batch number or code mark] reports are not all [accurate] [complete] [current]. Specifically, *** 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
3029 21 CFR 812.150(a)(4) Investigator report of emergency use The [sponsor] [reviewing IRB] was not notified [within five working days] of a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency situation.  Specifically, *** 1
3064 21 CFR 812.140(a)(4) Investigator protocol records inadequate Copies maintained of the study protocol are not all [accurate] [complete] [current].  Specifically, *** 1
3065 21 CFR 812.140(a)(5) Additional investigator records FDA requires Records that FDA requires by [regulation] [specific requirement] to be maintained for [a category of investigations] [a particular investigation] are not all [accurate] [complete] [current].  Specifically, *** 1
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, *** 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
3355 21 CFR 820.198(f) Records accessibility  Investigated complaints and records of investigation were not accessible to the manufacturing establishment.  Specifically, *** 1
3672 21 CFR 820.30(c) Design input - review and approval  Design input requirements were not [reviewed] [approved] by designated individual(s).  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
4207 21 CFR 806.10(d) Notification of extended action No amended notification with required information was submitted within 10 working days of initiating an extension of the correction or removal action.  Specifically,*** 1
4249 21 CFR 821.25(c) Not established, maintained Written procedures for the collection, maintenance, and auditing of device tracking information were not [established] [implemented] [complete] [provided to the FDA].  Specifically,*** 1
4278 21 CFR 821.50(a) Not available for inspection All device tracking records and all tracking information were not available for inspection.  Specifically,*** 1
4429 21 CFR 803.18(d)(2) Record retention period - distributor The device distributor has not maintained required copies of device complaint records [including information regarding the evaluation of the allegations] for a period of [2 years from the date of inclusion of the record in the file] [time equivalent to the expected life of the device].  Specifically, *** 1
4431 21 CFR 803.18(d)(1) Distributor's device incident records Device incident records kept by device distributors are not [prominently identified as such] [filed by device] [maintained in written form] [maintained in electronic form which is backed up].  Specifically, *** 1
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, *** 1
6803 21 CFR 807.20(a) Devices not listed Devices for which listing is required have not been listed.  Specifically, *** 1
6805 21 CFR 807.25(b) Device activities not reported Device activities have not been reported to FDA.  Specifically, *** 1
7006 21 CFR 812.43(c)(5) No financial disclosure info in investigator agreement A signed agreement was not obtained from each participating investigator that includes [sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement] [a commitment to promptly update financial disclosure information if any relevant changes occur during the investigation and for one year following completion of the study].  Specifically, *** 1
7019 21 CFR 812.150(b)(10) No sponsor report in response to a request In response to a request from [FDA] [a reviewing IRB], [accurate] [complete] [current] information about an  investigation was not provided.  Specifically, *** 1
9010 21 CFR 809.10(a)(2)  Intended use A statement of intended use(s) does not appear on the [product label] [outside container] [wrapper] of an in vitro diagnostic product.  Specifically, *** 1
9150 21 CFR 809.10(b)(14) Name/Address Labeling accompanying an in vitro diagnostic product labeling does not include the [name] [place of business] of the manufacturer, packer, or distributor.  Specifically, *** 1
9674 21 CFR 809.10(c)(2)(ii) Not exempt--lacks For Investigational Use statement  A [shipment] [delivery for product testing] of an in vitro diagnostic product prior to full commercial marketing, is  not exempt from the requirements for labels and accompanying labeling because all labeling does not bear a prominently placed statement "For Investigational Use Only.  The performance characteristics of this product have not been established.".  Specifically, *** 1
9676 21 CFR 809.10(e)(1)(v) Warnings or precautions statement Labeling for an analyte specific reagent product does not include [a statement of warnings or precautions as established in the regulations contained in 16 CFR part 1500] [warnings appropriate to the hazard presented by the product].  Specifically, *** 1
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, *** 1
14517 21 CFR 812.35(a)(1) No approval for changes requiring prior approval [FDA] [IRB] approval was not obtained for changes to an investigational plan that require prior approval.  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, *** 147
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, *** 133
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, *** 126
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, *** 85
1434 21 CFR 211.42(c)(10)(iv) Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.  Specifically, *** 78
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, *** 76
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, *** 73
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, *** 70
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, *** 65
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, *** 65
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, ***

 
63
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, *** 57
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, *** 55
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, ***

 
52
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, *** 49
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, *** 48
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, *** 48
1890 21 CFR 211.165(e) Test methods  The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].  Specifically, *** 47
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, *** 44
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, *** 41
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, *** 39
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, *** 36
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, , *** 35
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, *** 32
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, *** 31
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, *** 31
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, *** 30
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, *** 30
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, *** 29
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, *** 29
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, *** 28
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, *** 27
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, *** 27
9001 21 CFR 211.22(a) Lack of quality control unit There is no quality control unit.  Specifically, *** 26
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, *** 25
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, ***

 
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
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, *** 23
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, *** 23
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, *** 22
1912 21 CFR 211.166(a) Written program not followed The written stability testing program is not followed.  Specifically, *** 22
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, *** 22
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, *** 21
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, *** 21
3572 21 CFR 211.100(b) Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not [recorded] [justified].  Specifically, *** 21
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, *** 20
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, *** 20
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, *** 20
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, *** 20
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, *** 19
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, *** 18
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, *** 18
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, *** 18
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, *** 18
1162 21 CFR 211.28(a) Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.  Specifically, *** 17
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, *** 17
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, *** 17
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, *** 17
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, *** 16
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, *** 16
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, *** 15
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, ***  15
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, *** 15
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, *** 15
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, *** 15
4340 21 CFR 211.142 Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not [established] [followed].  Specifically, *** 15
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, *** 14
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, *** 14
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, *** 14
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, *** 14
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, *** 14
1227 21 CFR 211.67(c) Cleaning/maintenance records not kept Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment.  Specifically, *** 13
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, *** 13
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, *** 12
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, *** 11
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
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, *** 11
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, *** 11
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, *** 11
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, *** 11
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, *** 10
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, *** 10
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, *** 10
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, *** 10
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, *** 10
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, *** 10
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, *** 10
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,*** 9
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,*** 9
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, *** 9
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, *** 9
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, ***

 
8
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, *** 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, *** 8
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,  *** 8
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, *** 8
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, *** 8
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, *** 8
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, *** 8
4336 21 CFR 211.150 Written distribution procedure Written distribution procedures are not [established] [followed].  Specifically, *** 8
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, *** 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
8907 21 CFR 314.81(b)(1)(ii) Contamination, chemical or physical change, deterioration An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product.   Specifically, *** 8
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, ***  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
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, *** 7
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, *** 7
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, *** 7
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, *** 7
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, *** 7
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, ***  7
17764 21 CFR 212.20(e) Written QA procedures established, followed You did not [establish] [follow] written quality assurance procedures. Specifically,*** 7
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, *** 6
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, ***  6
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, *** 6
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, *** 6
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, *** 6
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, *** 6
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, *** 6
4302 21 CFR 211.56(b) Written sanitation procedures not followed Written procedures for sanitation are not followed.  Specifically, *** 6
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, ***    5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
17743 21 CFR 212.30(b) Equipment procedures overall You did not implement procedures to ensure that all your equipment is [properly installed] [maintained] [capable of repeatedly producing valid results].  Specifically,*** 5
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, *** 4
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
1163 21 CFR 211.28(b) Habits of good sanitation & health  Production personnel were not practicing good sanitation and health habits.  Specifically, *** 4
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, *** 4
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, *** 4
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, *** 4
1633 21 CFR 211.130(d) Examination of packaging and labeling Examination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not documented in the batch production records].  Specifically, *** 4
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,  *** 4
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, *** 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
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
4320 21 CFR 211.84(d)(6) Microbiological Contamination Exam Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.  Specifically, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
4378 21 CFR 211.188(b)(2) Identity of major equipment and lines used Batch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product produced.  Specifically, *** 4
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, *** 4
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, *** 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
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,*** 4
18008 FDCA 503B(a)(10) Drug product label, outsourcer facility The labels of your outsourcing facility?s drug products are deficient.  Specifically,*** 4
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, *** 3
1409 21 CFR 211.42(c)(4) In-Process Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials.  Specifically, *** 3
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, *** 3
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, *** 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
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, *** 3
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, ***

 
3
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,  *** 3
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, *** 3
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, *** 3
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, *** 3
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, *** 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
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, *** 3
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, *** 3
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, *** 3
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, *** 3
2400 21 CFR 211.194(a)(3) Statement of Sample Weights and Measures Laboratory records are deficient in that they do not include a statement of the [weight] [measure] of the sample used for testing.  Specifically, *** 3
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, *** 3
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, *** 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
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, *** 3
3573 21 CFR 211.101(b) Measured components for manufacturing Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate].  Specifically, *** 3
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, ***  3
3610 21 CFR 211.160(b)(3) Drug product sample Drug product samples are not [representative of the entire batch] [properly identified].  Specifically, *** 3
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, *** 3
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,*** 3
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, *** 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
4370 21 CFR 211.188(b)(10) Records of any sampling performed Batch production and control records do not include a record of any sampling performed, for each batch of drug product produced.  Specifically, *** 3
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, *** 3
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, *** 3
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, *** 3
4417 21 CFR 211.204 Associated batches implicated, investigated No appropriate investigation was conducted when a returned drug product appeared to implicate associated batches of drug products.   Specifically, *** 3
6735 21 CFR 314.80(c)(1)(ii) Failure to investigate serious, unexpected events Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated.  Specifically, *** 3
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, *** 3
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, *** 3
17742 21 CFR 212.30(b) Equipment not suitable You did not implement procedures to ensure that all your equipment is suitable for its intended purposes.  Specifically,*** 3
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,*** 3
1164 21 CFR 211.28(c) Unauthorized Personnel in Limited Access Areas Unauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas.  Specifically, *** 2
1384 21 CFR 211.101(c) Weighing/measuring/subdividing supervision Component [weighing] [measuring] [subdividing] operations are not adequately supervised.  Specifically, *** 2
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, *** 2
1431 21 CFR 211.42(c)(10)(ii) Temperature / Humidity Controls Aseptic processing areas are deficient regarding [temperature] [humidity]  controls.  Specifically, *** 2
1456 21 CFR 211.115(b) Reprocessing/quality control unit Reprocessing  was  performed without the [review] [approval] of the quality control unit.  Specifically, *** 2
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, *** 2
1506 21 CFR 211.122(e) Destruction of obsolete labeling Obsolete or outdated labels, labeling and packaging materials are not destroyed.  Specifically, *** 2
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, *** 2
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, ***  2
1724 21 CFR 211.134(b) Representative samples after completion Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations.  Specifically, *** 2
1774 21 CFR 211.142(a) Quarantine - actual practice Drug products are not quarantined before being released by the quality control unit.  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
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, *** 2
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, *** 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
2014 21 CFR 211.188(b)(2) Identification of Equipment and Lines The batch production and control records are deficient in that they do not  include the identity of major [equipment] [lines] used.  Specifically, *** 2
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, *** 2
2016 21 CFR 211.188(b)(4) Weights and Measures of Components Used The batch production and control records are deficient in that they do not  include [weights] [measures] of components used in the process.  Specifically, *** 2
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, *** 2
2019 21 CFR 211.188(b)(7) Documentation of Actual Yield and Theoretical Yield The batch production and control records are deficient in that they do not  include a statement of the [actual yield] [percentage of theoretical yield].  Specifically, *** 2
2086 21 CFR 211.208 Salvaging and return to marketplace Drug products that have been subjected to improper storage conditions  were salvaged and returned to the marketplace without further evidence or inspection.  Specifically, ***   2
2087 21 CFR 211.208 Salvaging performed without evidence Salvaging operations  on drug products which may have been subjected to improper storage conditions proceeded  in the absence of evidence from [laboratory tests and assays to establish that the drug products meet all applicable standards of identity, strength, quality and purity] [inspection of the premises to establish  that the drug products and their associated packaging were not subjected to improper storage conditions as a result of a disaster or accident].  Specifically, ***  2
2088 21 CFR 211.208 Organoleptic examinations sole basis Organoleptic examinations formed the sole basis to indicate that salvaged drug products meet appropriate standards of identity, strength, quality and purity, with no supplemental evidence.. Specifically, *** 2
2089 21 CFR 211.208 No records maintained No records are maintained for salvaged drug products.  Specifically, *** 2
2090 21 CFR 211.208 Records for salvaged drug products Records for salvaged drug products do not  include [name] [lot number] [disposition].  Specifically, *** 2
2569 21 CFR 211.198(b) Maintenance of Complaint File Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.  Specifically, *** 2
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, *** 2
3549 21 CFR 211.46(c) Air recirculation of dust from production areas Air is recirculated to production areas, without adequate measures to control recirculation of dust.  Specifically, *** 2
3552 21 CFR 211.48(a) Potable water not under positive pressure There is a failure to supply potable water under continuous positive pressure.  Specifically, *** 2
3554 21 CFR 211.48(a) Potable water standards not met The potable water being permitted for use in the potable water system fails to meet  standards prescribed by the Environmental Protection Agency.  Specifically, *** 2
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, *** 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
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, *** 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
4308 21 CFR 211.94(d) Written Procedures to Remove Pyrogens Not Followed Written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilizing] [methods of processing] to remove pyrogenic properties of drug product containers and closures are not followed.  Specifically, *** 2
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, *** 2
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, *** 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
4355 21 CFR 211.165(c) Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product.  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
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, *** 2
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, *** 2
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, ***

 
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
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, *** 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
4379 21 CFR 211.188(b)(1) Dates not included for each significant step Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the batch for each batch of drug product produced.  Specifically, *** 2
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, *** 2
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, ***  2
4416 21 CFR 211.204 Reprocessed returned drug products Returned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety, identity, strength, quality and purity.  Specifically, *** 2
6823 21 CFR 314.80(c) Failure by applicant to report ADE Adverse drug experience information has not been reported to FDA.  Specifically, *** 2
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, *** 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
6835 21 CFR 314.80(d) Failure to submit scientific article A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy of the published article.  Specifically, *** 2
8935 FDCA 760(b)(1) Failure of responsible person to report AE (non-RX Drug)   Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to the Secretary. Specifically, *** 2
17722 21 CFR 212.10 Lack Adequate Resources, Facilities, Equipment. You lack adequate [resources] [facilities] [equipment] to enable your personnel to perform their functions.  Specifically, *** 2
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,*** 2
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,*** 2
17759 21 CFR 212.20(c) Adverse effects of changes made You did not demonstrate that any change does not adversely affect the [identity] [strength] [quality] [purity] of your PET drug. 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
17813 21 CFR 212.50(a) Written control procedures You did not have written production and process control procedures to [ensure] [document] that [all key process parameters are controlled] [any deviations from the procedures are justified].  Specifically,*** 2
17839 21 CFR 212.50(c)(11) Results of investigations  Your batch production and control records did not include the results of any investigations conducted.  Specifically,*** 2
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,*** 2
17897 21 CFR 212.71(b) Investigation of nonconforming product You did not [completely] document the investigation of a PET drug product that did not meet specifications. Specifically,*** 2
1207 21 CFR 211.65(b) Substances That Come in Contact Substances required for equipment operations such as lubricants and coolants come in contact with [components] [drug product containers] [closures] [in-process materials] [drug product] so as to alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements.  Specifically, *** 1
1218 21 CFR 211.67(b)(1) Cleaning SOP/responsibility Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.  Specifically, *** 1
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, *** 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
1393 21 CFR 211.103 Yield calculations not verified by 2nd person Yield calculations are not performed by one person and independently verified by a second person.  Specifically, *** 1
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,*** 1
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,*** 1
1503 21 CFR 211.122(c) Records not kept for each shipment Records are not maintained for each shipment received of each different labeling and packaging material.  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
1546 21 CFR 211.125(d) Destruction of excess labels with lot numbers Excess labeling bearing lot or control numbers is not destroyed.  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
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
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, *** 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
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, ***  1
1817 21 CFR 211.84(c)(1) Cleaning of Component Containers Prior to Sampling Sample collection from component container is deficient regarding cleaning of the container after sampling.  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
1848 21 CFR 211.84(d)(5) Examination for Filth/Insect/Extraneous Material Examination of a lot of a component, drug product container or closures liable to contamination with [filth] [insect infestation] [or other extraneous adulterant] is deficiently examined against established specifications for such contamination.  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
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, *** 1
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, *** 1
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, *** 1
1977 21 CFR 211.182 Dedicated equipment: records part of batch record The records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record.  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
2022 21 CFR 211.188(b)(10) Documentation of Sampling Performed The batch production and control records are deficient in that they do not include documentation of sampling performed.  Specifically, *** 1
2025 21 CFR 211.188(b)(13) Results of drug product inspections and examinations The batch production and control records are deficient in that they do not include results of drug product [examinations] [inspections].  Specifically, *** 1
2035 21 CFR 211.194(e) Stability testing records not  included Laboratory records do not include complete records of all stability testing performed.  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
2404 21 CFR 211.194(a)(6) Comparison of Test Results to Specifications Laboratory records are deficient in that they do not include a statement of the results of tests and how they compare to the established [specifications] [standards].  Specifically, *** 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
3545 21 CFR 211.44 Adequate lighting not provided Adequate lighting is not provided in all  areas.  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
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, *** 1
3568 21 CFR 211.84(d)(3) Container/closure visual identification Visual identification is not conducted of [containers] [closures] that have been accepted based on the supplier's report of analysis.  Specifically, *** 1
3574 21 CFR 211.101(b)(1) Subdivided component container identification Containers holding subdivided components for drug product manufacturing are deficiently identified in that they lack the [component name] [item code].  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
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, *** 1
3594 21 CFR 211.110(d) Rejected in-process materials not quarantined Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable.  Specifically, *** 1
3596 21 CFR 211.122(g) Failure to include one of special control procedures Packaging and labeling operations involving the use of cut labels fail to include one of the three special control procedures provided for in the regulations ( e.g., dedicated lines, automated equipment for 100% exam, visual inspection for 100% exam).  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
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, *** 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
3609 21 CFR 211.160(b)(2) In-process sample representation/identification In-process samples are not [representative] [properly identified]. Specifically, *** 1
3630 21 CFR 211.170(b) Drug product reserve containers Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate container-closure system that has essentially the same characteristics as the marketed product].  Specifically, *** 1
3640 21 CFR 211.204 Returned drug products identified and held Returned drug products are not [identified as such] [held].  Specifically, *** 1
4310 21 CFR 211.84(c)(3) Sterile Equipment, Aseptic Techniques in sample collecting Failure to use [sterile equipment] [aseptic sampling techniques] when necessary in collecting a sample.  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
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, *** 1
4326 21 CFR 211.122(g)(2) Electronic or electromechanical equipment The packaging and labeling operation for cut labels which relies on the use of electronic or electromechanical equipment does not provide for 100-percent examination for correct labeling [during] [after completion of] finishing operations.  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
4343 21 CFR 211.160(b)(1) Incoming lots - conformance to written specs- Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] used in the manufacture, processing, packing, or holding of drug products.  Specifically, *** 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
4354 21 CFR 211.165(d) Acceptance/Rejection Levels The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].  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
4371 21 CFR 211.188(b)(9) Description of containers and closures Batch production and control records do not include a description of drug product [containers] [closures] used for each batch of drug product produced.  Specifically, *** 1
4386 21 CFR 211.198(b) Written complaint record  to be maintained at facility A written record of each complaint is not maintained in a file designated for drug product complaints [at the facility where the drug product was manufactured, processed or packed] [at a facility other than the facility in which the drug product was manufactured, processed or packed provided the written records are readily available for inspection at that other facility].  Specifically, ***  1
4393 21 CFR 211.186(b)(2) Name, weight of active ingredient; total weight or measure The master production and control records do not include [the name of each active ingredient] [the weight or measure of each active ingredient per dosage unit or per unit of weight or measure of the drug product] [a statement of the total weight or measure of any dosage unit].  Specifically, *** 1
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, *** 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
4412 21 CFR 211.194(a)(7) Signatures and dates--person who performs test Laboratory records do not include [the initials or signature of the person who performs each test] [the date(s) the tests were performed].  Specifically, *** 1
6706 21 CFR 310.305(c)(1)(i) Late submission Each post marketing 15-day Alert report was not submitted to FDA within 15 calendar days of initial receipt of the information.  Specifically, *** 1
6729 21 CFR 314.80(b) Failure to submit follow-up information to FDA Follow-up information has not been submitted on adverse drug experience reports provided to you by FDA.  Specifically, *** 1
6736 21 CFR 314.80(c)(1)(ii) Submission of report follow-up Follow-up reports were not submitted [within 15 calendar days of receipt of new information] [as requested by FDA] concerning post marketing 15-day reports.  Specifically, *** 1
6826 21 CFR 314.80(c)(1)(iii) Records not maintained by non-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 maintain complete records of these submissions, including [the date you received the information] [a copy of each adverse drug experience report] [the date the report was submitted to the applicant] [the name and address of the applicant].  Specifically, *** 1
6841 21 CFR 314.80(f)(1) Incomplete patient information on ICSR An ICSR failed to include [patient information code] [patient age at the time of the adverse drug experience or date of birth] [patient gender] [patient weight].  Specifically, *** 1
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, *** 1
8908 21 CFR 314.81(b)(2)(i) Summary An annual report did not include [a brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product] [a brief description of actions the applicant has taken or intends to take as a result of this new information] [a brief description of actions the applicant has taken or intends to take as a result of new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product] [a brief statement whether labeling supplements for pediatric use have been submitted and whether new studies in the pediatric population have been initiated].  Specifically, *** 1
8921 21 CFR 314.81(b)(2)(vii)(a) Post marketing study status report required information An annual, status report of a post marketing study did not include [the applicant's name] [the product name] [the NDA, ANDA, and supplement number] [the date of U.S. approval of NDA or ANDA] [the date of post marketing study commitment] [a description of the post marketing study commitment sufficient to uniquely describe the study] [a schedule for completion and reporting of the post marketing study commitment] [the current status of the post marketing study commitment] [an explanation of the study's status].   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
17002 FDCA 501(a) Drug Field Exam During a field examination of drug products at your facility the following [was] [were] observed: 1
17745 21 CFR 212.30(b) Equipment not properly maintained You did not document your activities in accordance with your procedures for ensuring the equipment suitability for its intended purposes.  Specifically,*** 1
17760 21 CFR 212.20(c) Initial specifications, methods, processes You did not approve or reject, before implementation, initial [specifications] [methods] [processes] [procedures] to ensure that they would maintain the identity, strength, quality and purity of a PET drug.  Specifically,*** 1
17769 21 CFR 212.40(a) Content of written procedures You did not [establish] [maintain] [follow] appropriate written procedures that describe the [receipt] [login] [identification] [storage] [handling] [testing] [acceptance and/or rejection] of [components] [drug product containers] [closures].  Specifically,*** 1
17770 21 CFR 212.40(a) Suitable for intended use Your written procedures are not adequate to ensure that the [components] [containers] [closures] are suitable for their intended use.  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
17780 21 CFR 212.40(c)(1)(ii) ID testing - components  You did not conduct identity testing on each lot of [component that yields an active ingredient] [inactive ingredient] in a PET drug product for which you did not conduct finished product testing to ensure that the correct components were used.  Specifically,*** 1
17787 21 CFR 212.40(d) Contamination, mix-ups and deterioration You did not handle and store [components] [containers] [closures] in a manner that prevents [contamination] [mix-ups] [deterioration] and ensures that they are and remain suitable for their intended use.  Specifically,*** 1
17822 21 CFR 212.50(b)(7) Complete instructions, procedures, specs Your master production and control records did not contain [complete production and control instructions] [complete sampling and testing procedures] [complete specifications] [special notations] [precautions to be followed].  Specifically,*** 1
17825 21 CFR 212.50(b)(3) List of components Your master production and control records did not [all] contain a complete list of components designated by names and codes sufficiently specific to indicate any special quality characteristic.  Specifically,*** 1
17837 21 CFR 212.50(c)(9) Labeling Your batch production and control records did not include labeling.  Specifically,*** 1
17841 21 CFR 212.50(d) Production area & equipment checks Your [production area] [equipment in the production area] was not checked to ensure [cleanliness] [suitability] immediately before use.  Specifically,*** 1
17853 21 CFR 212.60(d) Supplies adequately controlled Your [reagents] [solutions] [supplies] used in your testing procedures are not adequately controlled.  Specifically,*** 1
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,*** 1
17858 21 CFR 212.60(f) Documenting procedures You did not document the [calibration] [inspection] [checking] [maintenance] of laboratory equipment. Specifically,*** 1
17867 21 CFR 212.61(a) Stability testing program You did not [establish] [follow] [maintain] a written testing program to assess the stability characteristics of your PET drug products.  Specifically,*** 1
17872 21 CFR 212.70(a) Specifications You did not establish [adequate] specifications for each PET drug product, including criteria for determining [identity, strength, quality and purity] [sterility] [pyrogens].  Specifically,*** 1
17877 21 CFR 212.70(c) Conform to specs prior to release You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug conforms to specifications before final release.  Specifically,*** 1
17878 21 CFR 212.70(c) Sub-batches You did not conduct an appropriate laboratory determination on a PET drug produced in sub-batches before final release to ensure that each sub-batch conformed to specifications.  Specifically,*** 1
17918 21 CFR 212.70(f)(1)(iv) Correct malfunction, re-do test You approved a conditional final release of a PET drug product batch due to analytical equipment malfunction, but you did not [promptly correct the malfunction of analytical equipment] [complete the omitted test using the reserve sample after correcting the malfunction] [document that reasonable efforts had been made to prevent recurrence of the malfunction].  Specifically,*** 1
17920 21 CFR 212.70(f)(1)(vi) Documenting conditional release You approved a conditional release of a PET drug product due to analytical equipment malfunction, but you did not document all actions regarding the conditional final release of a PET drug product batch, including [the justification for the release] [all follow-up actions] [the results of completed testing] [all notifications] [corrective actions to prevent recurrence of analytical equipment malfunction].  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
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, *** 1
17965 21 CFR 361.1(c)(3) Annual reports not submitted to FDA The RDRC did not submit annual reports to FDA as required by regulations.  Specifically, *** 1
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, *** 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
18009 FDCA 503B(a)(10) Container label, outsourcer facility The container labels of your outsourcing facility?s drug products are deficient.  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, *** 314
1306 21 CFR 110.20(b)(7) Screening Failure to provide adequate screening or other protection against pests.  Specifically, *** 224
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, *** 202
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, *** 165
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, *** 162
905 21 CFR 123.6(b) HACCP plan implementation You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan.  Specifically, *** 148
1552 21 CFR 110.35(a) Buildings/sanitary Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.  Specifically, *** 143
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, *** 139
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, *** 131
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, *** 126
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, *** 123
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, *** 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
1581 21 CFR 110.37(e) Running water at suitable temperature Hand-washing facilities lack running water of a suitable temperature.  Specifically, *** 108
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, *** 105
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, *** 103
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, *** 95
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, *** 95
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*** 92
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, 89
1597 21 CFR 110.37(b)(3) As source of contamination Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils].  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, *** 85
2386 21 CFR 110.80(a)(1) Storage Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration].  Specifically, *** 84
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*** 82
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, *** 81
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, *** 76
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, *** 76
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, *** 76
1125 21 CFR 110.40(a) Materials and workmanship The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance].  Specifically, *** 75
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, *** 72
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, *** 69
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, *** 68
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, *** 68
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
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, *** 65
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, *** 63
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, *** 62
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,*** 59
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, *** 58
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, *** 56
1599 21 CFR 110.37(b)(5) Backflow prevention Lack of backflow protection from piping systems that discharge [waste water] [sewage].  Specifically, *** 55
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, *** 54
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, *** 52
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, ***  51
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, *** 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, *** 50
1698 21 CFR 110.80(b)(5) Work-in-progress Failure to handle work-in-progress in a manner that protects against contamination.  Specifically, *** 50
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, *** 50
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, *** 49
3658 21 CFR 110.37(e)(2) Hand cleaning and sanitizing preparations Lack of effective hand [cleaning] [sanitizing] preparations.  Specifically, *** 48
15927 21 CFR 111.103 Written procedures - quality control operations You did not [establish] [follow] written procedures for quality control operations.  Specifically, *** 48
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, *** 46
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, *** 44
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, *** 43
3659 21 CFR 110.37(e)(3) Hand drying Lack of a sanitary towel service or suitable hand drying devices.  Specifically, *** 43
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, *** 42
3654 21 CFR 110.37(d)(1) Maintained Failure to maintain toilet facilities in a sanitary condition.  Specifically, *** 40
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, *** 40
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, *** 39
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, *** 39
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, *** 38
15829 21 CFR 111.70(b)(1) Specifications - component identity  You did not establish an identity specification for each component.  Specifically, *** 38
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, *** 38
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, *** 37
3071 21 CFR 114.80(a)(1) Scheduled process Acidified food is not manufactured in accordance with the scheduled process.  Specifically, *** 37
3661 21 CFR 110.37(e)(5) Signs Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate.  Specifically, *** 37
12720 21 CFR 1.225 Not registered Your food facility is not registered as required.  Specifically, *** 36
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, *** 35
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, *** 35
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, *** 34
15830 21 CFR 111.70(b)(2) Specifications-component purity, strength, composition  You did not establish component specifications for [purity] [strength] [composition].  Specifically, *** 34
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, *** 33
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,*** 33
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, *** 33
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, *** 32
933 21 CFR 123.8(a)(2)(ii) Calibration - adequacy Your process monitoring equipment is not calibrated to ensure that it reads accurately.  Specifically, *** 31
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, *** 31
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, *** 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***



 
30
15641 21 CFR 111.453  Written procedures - holding  You did not [establish] [follow written] procedures for holding and distributing operations.  Specifically, *** 30
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, *** 28
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, *** 27
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, *** 27
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, *** 27
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, *** 27
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, *** 26
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, *** 26
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, *** 26
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, *** 26
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, *** 25
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, *** 25
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, *** 25
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, *** 25
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, *** 24
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, *** 24
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, *** 23
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, *** 23
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, *** 23
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, *** 22
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, *** 22
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, *** 22
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, *** 21
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, *** 20
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,  *** 20
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, *** 20
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, *** 19
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, *** 19
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, *** 19
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, *** 18
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, *** 18
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, *** 18
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, *** 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
15838 21 CFR 111.70(d) Specifications - labels, packaging  You did not establish [label] [packaging] specifications.  Specifically, ***

 
18
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, *** 17
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, *** 17
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, *** 17
932 21 CFR 123.7(d) Corrective action documentation You do not have records that document corrective actions that were taken.  Specifically, *** 16
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, *** 16
3656 21 CFR 110.37(d)(3) Self-closing doors Toilet facilities lack self-closing doors.  Specifically, *** 16
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, *** 16
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,*** 16
1129 21 CFR 110.40(a) Food-contact - corrosion resistant Lack of corrosion-resistant food contact surfaces.  Specifically, *** 15
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, *** 15
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, *** 15
1570 21 CFR 110.35(d)(5) Safe and adequate for use Sanitizing agents are [inadequate] [unsafe] under conditions of use.  Specifically, *** 15
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, *** 15
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, *** 15
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, *** 15
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, *** 15
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, *** 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
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, *** 14
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, "*** 14
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, *** 14
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, *** 13
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, *** 13
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, *** 13
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, *** 13
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, *** 13
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, *** 13
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, *** 13
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, *** 12
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, *** 12
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, *** 12
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, *** 12
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, *** 12
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, *** 12
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, ***
12
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, *** 12
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, *** 12
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, *** 12
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, ***  12
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, *** 12
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, *** 12
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, *** 12
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, *** 12
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, *** 11
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, *** 11
2361 21 CFR 110.80 Testing Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, *** 11
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, *** 11
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, *** 11
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, *** 11
15790 21 CFR 111.403  Written procedures - labeling operations  You did not [establish] [follow] written procedures for labeling operations.  Specifically, *** 11
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, *** 10
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, *** 10
1483 21 CFR 113.87(a) Operating processes not posted Operating processes for each product and container size were not [posted in a conspicuous place near the processing equipment] [readily available to the retort or processing system operator] [readily available to FDA investigators].  Specifically, *** 10
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, *** 10
3653 21 CFR 110.37(d) Readily accessible Failure to provide employees with [readily accessible] [adequate] toilet facilities.  Specifically, *** 10
3655 21 CFR 110.37(d)(2) Good repair Failure to keep toilet facilities in good repair.  Specifically, *** 10
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, *** 10
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, 10
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, *** 10
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, *** 10
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, *** 10
15410 21 CFR 111.14(b)(2) Personnel - records - training You did not make and keep documentation of training.  Specifically, *** 10
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, *** 10
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, *** 10
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, *** 10
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, *** 10
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, *** 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
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, *** 10
1425 21 CFR 110.20(b)(4) Spacing of equipment Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width].  Specifically, *** 9
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
2393 21 CFR 110.80(b)(1) Teardown equipment/thorough cleaning Failure to take apart equipment as necessary to ensure thorough cleaning.  Specifically, *** 9
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, *** 9
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, *** 9
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, *** 9
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, *** 9
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, *** 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
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, *** 8
1642 21 CFR 113.100(b) Review not signed/dated A [processing] [production] record was not [signed or initialed] [dated] by the reviewer.  Specifically, *** 8
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, *** 8
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, *** 8
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, *** 8
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, *** 8
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, *** 8
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, *** 8
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, *** 8
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, *** 8
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,  8
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,  *** 8
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, *** 8
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, *** 8
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, *** 8
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, *** 7
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, *** 7
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, *** 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
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, *** 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
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, *** 7
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, *** 7
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, ***

 
7
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, *** 7
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, *** 7
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, *** 7
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, *** 7
15660 21 CFR 111.475(b)(2)  Records - product distribution  You did not make and keep records of product distribution.  Specifically, *** 7
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, *** 7
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, *** 7
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, *** 7
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, *** 6
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, *** 6
1670 21 CFR 110.80(a)(4) Safety assurance - pests/extraneous materials There is no assurance that [raw materials] [ingredients] [rework materials] which are susceptible to contamination with [pests] [undesirable microorganisms] [extraneous materials] comply with current FDA standards and defect action levels.  Specifically, *** 6
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, *** 6
2888 21 CFR 113.40(j) Critical factors - frequency measured, recorded A critical factor specified in the scheduled process for processing a low-acid food in hermetically sealed containers was not [measured] [recorded] at intervals of sufficient frequency to ensure that the critical factor was within the limits specified in the scheduled process.  Specifically, *** 6
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, ***  6
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, *** 6
15401 21 CFR 111.12(b) Personnel - quality control operations You have not identified personnel to be responsible for your quality control operations.  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
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
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, *** 6
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, *** 6
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, *** 6
15736 21 CFR 111.353   Manufacturing operations - written procedures  You  did not [establish] [follow] written procedures for manufacturing operations.  Specifically, *** 6
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, *** 6
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, *** 6
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, *** 6
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, *** 6
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, *** 5
1331 21 CFR 113.100(a)(1) Still retorts For a still retort, records were not maintained for [the time that steam was turned on] [the time that the retort reached processing temperature] [the time that steam was shut off] [the venting time] [the venting temperature].  Specifically, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
3872 21 CFR 113.60(a)(3) Closures other than double seams and glass Appropriate detailed inspections and tests of containers were not conducted [by qualified personnel] [at intervals of sufficient frequency to ensure proper closing machine performance and consistently reliable hermetic seal production].  Specifically, *** 5
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, *** 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
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, *** 5
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, *** 5
15453 21 CFR 111.16 Written procedures - cleaning You did not [establish] [follow] written procedures for cleaning the physical plant.  Specifically, *** 5
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, *** 5
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, *** 5
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, *** 5
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, *** 5
15529 21 CFR 111.30(e) Equipment - controls, intended use You did not [establish] [use] appropriate controls to ensure that your automated, mechanical, or electronic equipment functions in accordance with its intended use.  Specifically, *** 5
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, *** 5
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, *** 5
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, *** 5
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, ***

 
5
15652 21 CFR 111.465(b) Retain reserve samples - 1 year, 2 years  You did not retain reserve samples for the required time.  Specifically, *** 5
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, *** 5
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,  5
15860 21 CFR 111.75(a)(2) Component - confirm identity; specifications met  You did not confirm the identity of components.  Specifically, *** 5
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, *** 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
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, *** 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
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, *** 5
16118 21 CFR 118.4 Written SE plan not implemented/followed Your written SE prevention plan is not [fully] implemented and followed. Specifically,*** 5
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, *** 5
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, *** 5
1325 21 CFR 113.100(g) Record retention Copies of required records were not maintained [at the processing plant for a period of not less than 1 year from the date of manufacture] [at the processing plant or other reasonably accessible location for an additional 2 years after the initial 1 year retention period].  Specifically, *** 4
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, *** 4
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, *** 4
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, *** 4
1706 21 CFR 110.80(b)(10) Mechanical manufacturing control Failure to perform mechanical manufacturing steps so as to protect food against contamination.  Specifically, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 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
15381 21 CFR 111.8 Written procedures - hygienic practices You did not [establish] [follow] written procedures for hygienic practices.  Specifically, *** 4
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, *** 4
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, *** 4
15443 21 CFR 111.15(b)(2) Physical plant - repair You did not maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.  Specifically, *** 4
15454 21 CFR 111.16 Written procedures - pest control You did not [establish] [follow] written procedures for pest control.  Specifically, *** 4
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, *** 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
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, *** 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
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
15737 21 CFR 111.210(h)(5) Corrective action plans The written instructions in your  master manufacturing did not include instructions for corrective action plans to use when specifications are not met.  Specifically, *** 4
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, *** 4
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, *** 4
15786 21 CFR 111.410(b) Labels - issuance, use  You did not control the [issuance] [use] of labels, Specifically, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 4
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, *** 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
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, *** 4
15999 21 CFR 111.127(h) QC operations - packaging, labeling; approving, rejecting Your quality control operations for packaging and labeling did not include approving for release, or rejecting, any packaged and labeled dietary supplement.  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
1093 21 CFR 110.40(g) Compressed air/gases Failure to ensure that compressed air or other gases [mechanically introduced into food] [used to clean food-contact surfaces or equipment] have been treated in such a way that foods are not contaminated with unlawful indirect food additives.  Specifically, *** 3
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, *** 3
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, *** 3
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, *** 3
1648 21 CFR 113.40(a)(1) No TID Each retort did not have at least one temperature-indicating device that accurately indicated the temperature during processing.  Specifically, *** 3
1660 21 CFR 113.40(a)(1)(v) TID not reference instrument The reference instrument for indicating the processing temperature was not a temperature-indicating device.  Specifically, *** 3
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, *** 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
1735 21 CFR 113.40(a)(2)(iii) Unauthorized adjustment A means of preventing unauthorized adjustment to the temperature-recording device was not provided.  Specifically, *** 3
2104 21 CFR 113.40(a)(13)(iii) 15 minute interval (S) Measurements and recordings of critical factors specified in the scheduled process were not made at intervals of 15 minutes or less.  Specifically, *** 3
2144 21 CFR 113.40(b)(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, *** 3
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, *** 3
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, *** 3
2389 21 CFR 110.80(a)(5) Identify rework Failure to identify material scheduled for rework as such. 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
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, *** 3
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, *** 3
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, *** 3
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, *** 3
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, *** 3
4421 21 CFR 110.20(a) Maintenance of grounds Maintenance of the grounds is inadequate to protect against contamination of food.  Specifically, ***  3
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, *** 3
4530 21 CFR 114.100(c) Process deviations - product disposition Failure to record the disposition of product involved in a departure from a scheduled process.  Specifically, *** 3
6002 21 CFR 123.11(b) Sanitation corrections You did not correct sanitation deficiencies in a timely manner.  Specifically,*** 3
12732 21 CFR 120.10(a) Corrective action - predetermined plan Your HACCP plan includes a corrective action plan.  There was a deviation from a critical limit and you did not take corrective action that ensured [product that was injurious to health or otherwise adulterated did not enter commerce] [the cause of the deviation was corrected].  Specifically, *** 3
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, *** 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
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, *** 3
15491 21 CFR 111.25 Equipment - procedures You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and utensils.  Specifically, *** 3
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, *** 3
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, *** 3
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, *** 3
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,  *** 3
15550 21 CFR 111.260(j) Batch record - manufacture Your batch production records did not include documentation, at the time of performance, of the manufacture of the batch.  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
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, *** 3
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, *** 3
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, *** 3
15570 21 CFR 111.153 Written procedures - components You did not [establish] [follow] written procedures for the requirements for components of dietary supplements.  Specifically, *** 3
15572 21 CFR 111.153  Written procedures - labels  You did not [establish] [follow] written procedures for the requirements for labels received.  Specifically, *** 3
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, *** 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
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, *** 3
15624 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, *** 3
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,  *** 3
15675 21 CFR 111.315(b) Sampling plans; establish, follow You did not [establish] [follow] sampling plans for obtaining representative samples.  Specifically, *** 3
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, *** 3
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, *** 3
15751 21 CFR 111.210(d) Master manufacturing record - Supplemental Facts  Your master manufacturing record did not include the [identity] [weight or measure] of each dietary ingredient that will be declared on the Supplement Facts label.  Specifically, *** 3
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, *** 3
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, *** 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
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, *** 3
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, *** 3
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, *** 3
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, *** 3
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, *** 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
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, *** 3
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, *** 3
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, *** 3
15989 21 CFR 111.127 Quality control operations - packaging, labeling You do not have quality control operations for [packaging] [labeling].  Specifically, *** 3
16016 21 CFR 111.140(b)(2)(ii)   Signature; review, approval, rejection; reprocessing Your written documentation that quality control personnel reviewed, approved, or rejected for reprocessing did not include the signature of the person performing the review, approval, or rejection.  Specifically, *** 3
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, *** 3
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, *** 3
16135 21 CFR 118.4(b)(4) Stray animals Stray animals are not prevented from entering poultry houses.  Specifically,*** 3
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,*** 3
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, *** 3
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, *** 2
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, *** 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, *** 2
949 21 CFR 123.12(c) Records, English The records that document the performance and results of the affirmative step you chose are not in English.   Specifically, *** 2
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, *** 2
1045 21 CFR 113.10 Supervisors Supervisors have not satisfactorily completed training in a school approved by the Commissioner for areas under their responsibility.   Specifically, *** 2
1060 21 CFR 123.11(a) SSOP(S) You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP).  Specifically, *** 2
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,*** 2
1317 21 CFR 113.87(d) Thermal processing - timing devices A timing device used in recording thermal process time information was not accurate to the extent needed to ensure that the [processing time] [venting time]

specified in the scheduled process [was] [were] achieved.  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
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, *** 2
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, *** 2
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, *** 2
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, *** 2
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, *** 2
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, *** 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
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, *** 2
2156 21 CFR 113.40(b)(2)(iv) Recorder-controller sensor: placement, vertical retort The temperature recorder-controller sensor for a vertical retort equipped with a combination recorder-controller was not located at the bottom of the retort below the lowest crate rest in such a position that the steam did not strike it directly.  Specifically, *** 2
2167 21 CFR 113.40(b)(10) No indicator A retort did not have a means of determining the water level in the retort during operation.  Specifically, *** 2
2838 21 CFR 113.40(g)(1)(i)(A) No accurate TID Each product sterilizer did not have at least one temperature-indicating device that accurately indicated the temperature during processing.  Specifically, *** 2
2846 21 CFR 113.40(g)(1)(i)(B)(1) Recorder 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, *** 2
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, *** 2
3090 21 CFR 114.100(d) Product distribution Records identifying initial distribution of finished product are not maintained.  Specifically, *** 2
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, *** 2
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, *** 2
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, *** 2
3800 21 CFR 113.40(a)(1) TID identity - tag, seal A temperature-indicating device did not have a tag, seal, or other means of identity.  Specifically, ***  2
3862 21 CFR 113.60(a)(1) Teardown examinations - did not perform Teardown examinations for double-seam cans were not performed [by a qualified individual].  Specifically, *** 2
3875 21 CFR 113.60(b) Cooling water - residual sanitizer (S) There was no measurable residual of the cooling water sanitizer at the water discharge point of the container cooler.  Specifically, *** 2
3879 21 CFR 113.60(d) Postprocess handling: checks, repairs Container handling equipment was not [checked with sufficient frequency] [repaired or replaced as necessary] to prevent damage to containers and container closures.  Specifically, *** 2
4295 21 CFR 110.40(a) Food contact - non-toxic materials Food-contact surfaces are not made of non-toxic materials.  Specifically, *** 2
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, *** 2
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, *** 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
9917 21 CFR 120.10(c) Corrective action documentation You do not have records that [fully] document corrective actions that were taken.  Specifically, *** 2
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, *** 2
9933 21 CFR 120.6(b) GMP correction - timely  You do not [always] correct deficiencies from good manufacturing practice in a timely manner.  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
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, *** 2
12721 21 CFR 1.234 Registration not updated You did not submit an update to your facility's registration within 60 calendar days of [a change] [changes] to the registration information previously submitted.  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
15389 21 CFR 111.10(b)(1) Outer garments Your personnel did not wear outer garments in a manner that protects against contamination of components, dietary supplements or contact surfaces.  Specifically, *** 2
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, *** 2
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, *** 2
15400 21 CFR 111.12(a) Personnel - qualified - general Your personnel are not qualified to [manufacture] [package] [label] [hold] dietary supplements.  Specifically, *** 2
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, *** 2
15405 21 CFR 111.13(a) Supervisor - qualified You have not assigned qualified personnel to supervise the [manufacturing] [packaging] [labeling] [holding] of dietary supplements].  Specifically, *** 2
15433 21 CFR 111.15(d)(1) Animals and pests in facility You allowed [animals] [pests] in your physical plant. Specifically, *** 2
15447 21 CFR 111.15(c)(3) Cleaning compounds and toxic materials - holding You did not [identify] [hold] cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces.  Specifically, *** 2
15468 21 CFR 111.20(c)(2) Physical plant - material review and disposition 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 supplements by separating components, dietary supplements, packaging, and labels that are to be used in manufacturing from those that are awaiting material review and disposition decision, reprocessing, or disposal.  Specifically, ***  2
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, *** 2
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, *** 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
15535 21 CFR 111.255(d)  Batch record - 1 year, 2 years You did not keep batch production records for the required time period.  Specifically, ***

 
2
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,  *** 2
15539 21 CFR 111.260(a)(1)  Batch record - control number, finished batch Your batch production records did not include the batch, lot, or control number of the finished batch of dietary supplement.  Specifically, *** 2
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, *** 2
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, *** 2
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, *** 2
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, *** 2
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, *** 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
15601 21 CFR 111.160(e) Packaging, labels - contamination, deterioration  You did not hold [packaging] [labels] under conditions that will protect against contamination or deterioration.  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
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, ***



 
2
15615 21 CFR 111.180(a) Records - components, packaging, labels, product received:   You did not keep records required for [components] [packaging] [labels] [product received for packaging or labeling] for the required time period.  Specifically, *** 2
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, *** 2
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, 2
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,  *** 2
15630 21 CFR 111.180(b)(3)(i) Document - required operation  The person who performed a required operation did not document, at the time of performance, that the required operation was performed.  Specifically, *** 2
15662 21 CFR 111.303 Written procedures - laboratory operations  You did not [establish] [follow] written procedures for laboratory operations. Specifically, *** 2
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,  *** 2
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, *** 2
15708 21 CFR 111.325(a) Written procedures, laboratory operations You did not make and keep written procedures for laboratory operations. Specifically, *** 2
15712 21 CFR 111.325(b)(2)(ii) Records - document; results  The documentation for laboratory tests and examinations did not include the results of the testing and examination.  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
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, *** 2
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, *** 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
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,  *** 2
15750 21 CFR 111.210(d) Master manufacturing record - ingredients list  Your master manufacturing record did not include the identity of each ingredient that will be declared on the ingredients list of the dietary supplement.  Specifically, *** 2
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, *** 2
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, *** 2
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, *** 2
15784 21 CFR 111.410(c)  Packaging, labels - master manufacturing record  You did not examine, before [packaging] [labeling] operations, [packaging] [labels] for each batch of dietary supplement to determine whether the [packaging] [labels] conformed to the master manufacturing record.  Specifically, *** 2
15785 21 CFR 111.410(b) Label, packaging - discrepancies  You did not control the reconciliation of any issue and use [label discrepancies] [packaging discrepancies].  Specifically,  *** 2
15787 21 CFR 111.410(b)  Packaging - issuance, use  You did not control the [issuance] [use] of packaging.  Specifically, *** 2
15791 21 CFR 111.403  Written procedures -packaging operations  You did not [establish] [follow] written procedures for packaging operations.  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
15820 21 CFR 111.55 Production, process controls - packaged, labeled  You did not implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record.  Specifically, *** 2
15823 21 CFR 111.60(b) Production, in-process control system review, approved Your production and in-process control system was not reviewed and approved by quality control personnel.  Specifically, *** 2
15847 21 CFR 111.73 Specifications met - component identity  You did not determine whether you met identity specifications established for components.  Specifically, *** 2
15848 21 CFR 111.73   Specifications met - component purity, strength, composition You did not determine whether you met established component specifications established to ensure the [purity] [strength] [composition] of dietary supplements manufactured using the components.  Specifically,  *** 2
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, *** 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
15880 21 CFR 111.75(f)(2) Label - visual examination, review supplier's documentation  You did not [conduct a visual examination of the label] [review the supplier's invoice, guarantee, or certification] to determine whether label specifications are met.  Specifically, *** 2
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,  *** 2
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, *** 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
15920 21 CFR 111.95(b)(1) Records - established specifications  You did not make and keep records of established specifications.  Specifically, *** 2
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, *** 2
15931 21 CFR 111.105 Quality control - packaged, labeled Your quality control personnel did not ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record.  Specifically, *** 2
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, *** 2
15950 21 CFR 111.110(b) Quality control operations - tests, examinations Your quality control operations did not include ensuring that [tests] [examinations] required for your laboratory operations were conducted.  Specifically, *** 2
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, *** 2
15957 21 CFR 111.113(a)(4)   QC- calibration; quality; material review, disposition Your quality control personnel did not conduct a material review and make a disposition decision when calibration of an instrument or control suggested a problem that may have resulted in a failure to ensure the quality of [a batch] [batches] of a dietary supplement.  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
15967 21 CFR 111.117(b)   Quality control operations - calibration records Your quality control operations did not include periodically reviewing all records for calibration of instruments and controls.  Specifically, *** 2
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,  *** 2
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, *** 2
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, *** 2
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, *** 2
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, *** 2
16004 21 CFR 111.130(b)   Returned dietary supplement; salvage, redistribution Your quality control operations for returned dietary supplements did not include approving or rejecting salvage and redistribution of a returned dietary supplement.  Specifically, *** 2
16007 21 CFR 111.135 Quality control operations - product complaints You do not have quality control operations for product complaints.  Specifically, *** 2
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, *** 2
16038 21 CFR 111.605(b)  Records - original, true copies  You did not keep original records, true copies, or electronic records. Specifically,   *** 2
16046 21 CFR 111.503  Written procedures returned dietary supplement investigation You did not [establish] [follow] written procedures for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement.  Specifically, *** 2
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, *** 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
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, *** 2
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,*** 2
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,*** 2
16192 21 CFR 118.10(a)(3)(1) Biosecurity measures documentation You did not maintain records documenting compliance with biosecurity 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
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,*** 2
16492 FDCA 601(a) Poisonous substance Your cosmetic bears or contains a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling or under the conditions of use that are customary or usual.  Specifically, *** 2
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, *** 2
976 21 CFR 123.9(b)(2) Process adequacy records The records that relate to the general adequacy of your [processes] [equipment] were not maintained for at least two years after their applicability to the product you produced.  Specifically, *** 1
1188 21 CFR 110.37(c) Sewage disposal Failure to dispose of sewage into an adequate sewerage system or by other adequate means.  Specifically, *** 1
1288 21 CFR 110.20(a)(2) Roads/yards/parking lots Failure to properly maintain [roads] [yards] [parking lots] so that they do not constitute a source of contamination in areas where food is exposed. Specifically, *** 1
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, *** 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
1305 21 CFR 113.81(f) Water activity - supervision Failure to carefully supervise the equilibrium water activity of the finished product to ensure that the water activity requirements of the scheduled process are met.  Specifically, *** 1
1379 21 CFR 129.35(a)(4)(iv) Quality standards - compliance Finished bottled water did not comply with the bottled water quality standards. Specifically, *** 1
1401 21 CFR 129.37(a) Product water-contact surfaces - inspection You did not inspect all product water-contact surfaces as often as necessary [to maintain the sanitary condition of such surfaces] [to assure such surfaces are kept free of scale, evidence of oxidation, and other residue].  Specifically, *** 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
1423 21 CFR 129.37(d) Containers kept sanitary You did not [fill] [cap] [close] [seal] [package] containers in a sanitary manner so as to preclude contamination of the bottled drinking water. Specifically, *** 1
1486 21 CFR 113.87(b) Retort room: traffic control system not established A system of traffic control to prevent unretorted product from bypassing the retort process was not established.  Specifically, *** 1
1532 21 CFR 113.100(a)(7) Other systems - records; critical factors Records were not maintained for critical factors specified [in the formulation of the product] [in the scheduled process].  Specifically, *** 1
1559 21 CFR 110.35(c) Guard/guide dogs The [guard dog] [guard dogs] [guide dog] [guide dogs] in the plant [is] [are] likely to result in the contamination of [food] [food-contact surfaces] [food-packaging materials].  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
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, *** 1
1655 21 CFR 113.40(a)(1)(v) TID sensor - retort shell, well A temperature-indicating device sensor was not either within the retort shell or in an external well attached to the retort.  Specifically, *** 1
1659 21 CFR 113.40(a)(1)(v) Well bleeders - continuous steam emission A bleeder for an external well for a temperature-indicating device did not emit steam continuously during the entire processing period.  Specifically, *** 1
1691 21 CFR 113.40(a)(4) Steam controller A retort was not equipped with an automatic steam controller to maintain the retort temperature.  Specifically, *** 1
1731 21 CFR 113.40(a)(2) Present each retort, accurate Each retort did not have an accurate temperature-recording device.    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
1746 21 CFR 113.40(a)(6) Bottom crate supports A vertical still retort did not have a bottom crate support.  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
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
1944 21 CFR 129.80(d) Sanitizing operations inadequate Sanitizing operations were not adequate to sanitize the intended [product water-contact surfaces] [critical areas]. Specifically, *** 1
2105 21 CFR 113.40(a)(13)(iv) Can positioning The positioning of containers in a still retort was not according to the scheduled process.  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
2143 21 CFR 113.40(b)(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
2148 21 CFR 113.40(b)(1)(v) Sensor: beneath water, circulation A temperature-indicating device sensor was not located [so that it was beneath the surface of the water throughout the process] [where there was adequate circulation to ensure accurate temperature measurement].  Specifically, *** 1
2150 21 CFR 113.40(b)(2) Present each retort, accurate Each retort did not have an accurate temperature-recording device.  Specifically, *** 1
2151 21 CFR 113.40(b)(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
2207 21 CFR 113.40(b)(15)(i) Fill-in weight, drained weight - recording frequency The [maximum fill-in weight] [drained weight] specified in the scheduled process was not [measured] [recorded] at intervals of sufficient frequency to ensure that the weight of the product did not exceed the maximum for the container size as specified in the scheduled process.  Specifically, *** 1
2220 21 CFR 113.40(b)(9) Pressure controller An automatic pressure control unit was not used to control pressure in [a horizontal retort] [a vertical still retort] for pressure processing in water.  Specifically, *** 1
2221 21 CFR 113.40(b)(9) Check valve A check valve to prevent water from entering the system was not provided in the air supply line.  Specifically, *** 1
2229 21 CFR 113.40(b)(15)(iv) Can positioning The positioning of containers in a still retort was not according to the scheduled process.  Specifically, *** 1
2272 21 CFR 129.80(e) Records - product, volume, date, code, distribution You did not record and maintain information as to the [kind of product] [volume produced] [date produced] [lot code used] [distribution of finished product to wholesale and retail outlets].  Specifically, *** 1
2306 21 CFR 113.40(c)(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
2320 21 CFR 113.40(c)(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
2321 21 CFR 113.40(c)(2)(iii) Unauthorized adjustment A means of preventing unauthorized adjustment to the temperature-recording device was not provided.  Specifically, *** 1
2582 21 CFR 113.40(c)(10) Minimum headspace Minimum headspace of containers was not [measured] [recorded] at intervals of sufficient frequency to ensure that the headspace is as specified in the scheduled process.  Specifically, *** 1
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, *** 1
2899 21 CFR 113.40(g)(2)(ii)(C) Operating conditions - observed, recorded The [media flow rates] [temperatures] [container and closure rates through the sterilizing system] [sterilization conditions of a batch system used for container sterilization] [operating conditions] were not [observed] [recorded].  Specifically, *** 1
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, *** 1
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,  *** 1
3644 21 CFR 110.10(b)(5) Impermeable (S) Gloves used for food handling are not impermeable.  Specifically,  *** 1
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, *** 1
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, *** 1
3709 21 CFR 110.80(a)(1) Inspection of containers and carriers upon receipt Failure to inspect [containers] [carriers] of raw materials upon receipt to ensure that their condition does not contribute to the contamination or deterioration of food.  Specifically, *** 1
3771 21 CFR 113.40(a)(7) Location of steam spreader perforations (S) Perforations in the steam spreader along the bottom of the retort were not located along the top 90 degrees of the steam spreader.  Specifically, *** 1
3856 21 CFR 113.60(a) Frequency: visual closure examination, qualified person. A qualified container closure inspection person did not visually examine [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, *** 1
3857 21 CFR 113.60(a) Record: visual closure examination, qualified person A qualified container closure inspection person did not record visual observations of gross closure defects.  Specifically, *** 1
3860 21 CFR 113.60(a) Closure inspection following jams - record A pertinent observation from visual closure inspection made [following a jam in a closing machine] [after a closing machine adjustment] [after startup of a machine following a prolonged shutdown] 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
3870 21 CFR 113.60(a)(2) Glass containers; cold water vacuum check The capper efficiency for glass containers with vacuum closures was not checked by a measurement of the cold water vacuum before filling operations.  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
3888 21 CFR 113.40(b)(15)(iii) 15 minute interval (S) Critical factors specified in the scheduled process were not [measured] [recorded] at intervals of 15 minutes or less.  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
4062 21 CFR 113.100(a) Critical factors - no record A record was not was not made of [the closing machine vacuum in vacuum-packed products] [the maximum fill-in weight] [the drained weight] [a critical factor specified in the scheduled process].  Specifically, *** 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
4460 21 CFR 114.80(a)(1) Use of preservatives (S) Failure to use preservatives (in lieu of thermal processing) to inhibit reproduction of microorganisms of non-health significance. Specifically, ***  1
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, *** 1
4520 21 CFR 108.35(c)(3)(ii) Process information availability Failure to provide FDA, when requested in writing, with information concerning processes and procedures deemed necessary to determine the adequacy of the process. Specifically, *** 1
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, *** 1
9847 21 CFR 107.50(e)(2) Notify FDA district - adulterated exempt, infant formula You did not [promptly] notify FDA by telephone that you had knowledge that reasonably supports the conclusion that an exempt infant formula you processed and that left an establishment subject to your control may be adulterated and presents a risk of human health.  Specifically, *** 1
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, *** 1
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, *** 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
9938 21 CFR 120.7(d) Hazard analysis - evaluation of effect on safety (S) You did not evaluate [product ingredients] [processing procedures] [packaging] [storage] [intended use] [facility and equipment function and design] [plant sanitation, including employee hygiene] to determine the potential effect on the safety of the finished food for the intended consumer.  Specifically, *** 1
9959 21 CFR 120.12(d)(1) Record retention - general You do not retain [all of] the required records at your facility for the required time period.  Specifically, *** 1
9964 21 CFR 120.25 Finished product not analyzed for E.coli You do not [always] analyze your finished juice product for biotype I Escherichia coli.   Specifically, *** 1
9965 21 CFR 120.25(b) Process verification - sampling each product You do not [always] take samples from each juice product you produce that is subject to the requirements for Escherichia coli analysis.  Specifically, *** 1
9969 21 CFR 120.25(a) Process verification - sample size You did not [randomly] take the required samples for Escherichia coli testing for the amount of juice produced [from finished consumer packages].  Specifically, *** 1
12709 21 CFR 129.80(c) Records - cleaning, sanitizing solutions You did not maintain records of [sampling] [testing] of cleaning and sanitizing solutions.  Specifically, *** 1
12725 21 CFR 129.80(b)(1) Mechanical washers - inspection You did not inspect mechanical washers [as often as necessary] to assure adequate performance.  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
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, *** 1
15352 FDCA 761(b)(1) No label copy submitted with AE report (dietary supplement)  Copies of labels from on or within the retail package of a dietary supplement did not accompany serious drug event report. Specifically, *** 1
15396 21 CFR 111.10(b)(6) Hair restraints Your personnel did not wear [effective] hair restraints [in an effective manner].  Specifically, *** 1
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, *** 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
15430 21 CFR 111.15(k) Sanitation supervisors - qualified The [supervisor] [supervisors] you assigned to supervise sanitation [is] [are] not qualified by education, training, or experience to develop and supervise sanitation procedures.  Specifically, *** 1
15432 21 CFR 111.15(e)(2) Water supply - may be component - suitability Water that was used a manner such that the water may become a component of a dietary supplement did not comply with applicable [Federal] [State] [local] requirements.  Specifically, *** 1
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, ***        1
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, *** 1
15446 21 CFR 111.15(c)(2) Toxic materials - use You [used] [held] toxic materials in your physical plant that were not necessary to maintain clean and sanitary conditions, for use in laboratory testing procedures, for maintaining or operating your physical plant or equipment, or for use in your plant's operations.  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
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, *** 1
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, *** 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
15473 21 CFR 111.20(c)(7) Physical plant - separate areas - holding You [did not have] [did not use] separate or defined areas of adequate size or other control systems prevent contamination or mix-ups of components or dietary supplements during holding operations.  Specifically, *** 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
15504 21 CFR 111.27(a)(3)(iv) Equipment - withstand environment Your equipment or utensils are not designed or constructed to withstand [the environment in which they are used] [the action of components or dietary supplements] [cleaning compounds and sanitizing agents].  Specifically, *** 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
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, *** 1
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, *** 1
15527 21 CFR 111.30(c) Equipment - automated - QC check Your quality control personnel did not periodically review routine [calibrations] [inspections] [checks] of your automated, mechanical, or electronic equipment.  Specifically, *** 1
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, *** 1
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, *** 1
15574 21 CFR 111.153  Written procedures - rejected components, packaging, labels You did not [establish] [follow] written procedures for the requirements for rejected components, packaging, or labels.  Specifically, *** 1
15575 21 CFR 111.153 Written procedures - rejected products  You did not [establish] [follow] written procedures for the requirements for rejected products that are received for packaging or labeling as a dietary supplement.  Specifically, *** 1
15581 21 CFR 111.155(c)(3) Quality control - components, approve, release Your quality control personnel did not [approve components while the components were quarantined] [release components from quarantine] for use in the manufacture of a dietary supplement.  Specifically, *** 1
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,  *** 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
15591 21 CFR 111.160(c)(1) Labels - quarantine; samples You did not collect representative samples of labels while the labels were quarantined.  Specifically, *** 1
15596 21 CFR 111.160(c)(3) Packaging - quality control; approve, release Your quality control personnel did not approve packaging for use in the manufacture of a dietary supplement and release it from quarantine.  Specifically, *** 1
15606 21 CFR 111.165(c)(1) Product received - quarantine; representative samples  You did not collect representative samples of received product while the received product was quarantined.  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
15627 21 CFR 111.180(b)(3) Documentation - product received; packaging, labeling  You did not make and keep documentation that the requirements that apply to production and process control for product received for packaging or labeling as a dietary supplement were met.  Specifically, *** 1
15647 21 CFR 111.460(b) Hold - in-process material; temperature, humidity, light  You did not hold in-process material under appropriate conditions of temperature, humidity, and light.  Specifically, *** 1
15648 21 CFR 111.465(a)(2) Hold - reserve sample; 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, *** 1
15651 21 CFR 111.465(a)(2) Hold - reserve sample; closure system- packaged, labeled Your reserve sample of a dietary supplement that was distributed to be packaged and labeled was not held using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it was distributed for packaging and labeling elsewhere.  Specifically, *** 1
15671 21 CFR 111.315 Laboratory control  processes - requirements  You did not [establish] [follow] laboratory control processes.  Specifically, *** 1
15673 21 CFR 111.315(a) Criteria for establishing specifications  You did not [establish] [follow] laboratory control processes for use of criteria for establishing appropriate specifications.  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
15687 21 CFR 111.315(b)(4)   Sampling plans; product for packaging, labeling You did not [establish] [follow] sampling plans for obtaining representative samples of product that you received for packaging or labeling as a dietary supplement.  Specifically, *** 1
15691 21 CFR 111.315(b)(2)  Sampling plans; in-process materials You did not [establish] [follow] sampling plans for obtaining representative samples of in-process materials.  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
15710 21 CFR 111.325(b)(2)(i) Document; laboratory methodology followed The person who conducted the testing and examination did not document [at the time of performance] that established laboratory methodology was followed.  Specifically, *** 1
15716 21 CFR 111.375(a) Records - manufacturing operation:  readily available  You did not have records or copies of records required for manufacturing operations readily available during the required retention period for inspection and copying by FDA when requested.  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
15724 21 CFR 111.365(h)  Mechanical steps - contamination  You did not perform mechanical manufacturing steps by effective means to protect the dietary supplements against contamination.  Specifically, *** 1
15725 21 CFR 111.365(g) Identifying, holding - contamination, mix-ups  You did not identify and hold [components] [dietary supplements] for which a material review and disposition decision is required in a manner that protects [components] [dietary supplements] that are not under a material review against contamination and mix-ups with those that are under a material review.  Specifically, *** 1
15726 21 CFR 111.365(f) Holding - prevent becoming adulterated  You did not hold [components] [dietary supplements] that can support the rapid growth of microorganisms of public health significance in a manner that prevents them from becoming adulterated.  Specifically, *** 1
15730 21 CFR 111.365(c)  Water - Federal, State, local requirements  The water you used that may become a component of a finished batch of dietary supplement, did not at minimum comply with the applicable Federal, State, and local requirements.  Specifically, *** 1
15734 21 CFR 111.360   Manufacturing operations - sanitation  You did not conduct manufacturing operations in accordance with adequate sanitation principles.  Specifically, *** 1
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, *** 1
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, *** 1
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, *** 1
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, *** 1
15766 21 CFR 111.430(a) Records - packaging, labeling operations: 1 year, 2 years  You did not keep the records required for your packaging and labeling operations for the required time period.  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
15775 21 CFR 111.415(e)  Dietary supplement containers - mix-ups  You did not [identify] [identify by effective means] filled dietary supplement containers that are set aside and held in unlabeled condition for future label operations, to prevent mix-ups.  Specifically, *** 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
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
15780 21 CFR 111.415 Fill, assemble, package, label - master record  You did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a way that ensured that the dietary supplement is packaged and labeled as specified in the master manufacturing record.  Specifically, *** 1
15803 21 CFR 111.560? 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
15806 21 CFR 111.570(a) Records - product complaints:  originals, copies, electroni You did not keep the records required for product complaints as original records, true copies, or as electronic 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
15812 21 CFR 111.570(b)(2)(ii)(A)  Record - product complaint; name, description  The written record of a product complaint did not include the name and description of the dietary supplement.  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
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, *** 1
15826 21 CFR 111.65 Quality control - packaged, labeled  You did not implement quality control operations to ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record.  Specifically, *** 1
15835 21 CFR 111.70(c)(2) Documentation specifications - contamination limits  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 limits on contamination that may adulterate or may lead to adulteration of the finished dietary supplement.  Specifically, *** 1
15846 21 CFR 111.73  Specifications met - packaged, labeled, master record  You did not determine whether you met specifications established to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.  Specifically, *** 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
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, *** 1
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, *** 1
15876 21 CFR 111.75(d)(2) Exempted, periodic testing; quality control Your quality control personnel did not review and approve the documentation of why an exempted product specification is met without verification through periodic testing of the finished batch.  Specifically, *** 1
15881 21 CFR 111.75(g)  Packaging, labeling - visual examination   You did not conduct a visual examination of the [packaging] [labeling] of the finished [packaged] [labeled] dietary supplements to determine whether you [used] [applied] the specified label.  Specifically, *** 1
15890 21 CFR 111.80(a) Components packaging, labels used You did not collect representative samples of each unique lot of [components] [packaging] [labels] that you used to determine whether the [components] [packaging] [labels] meet(s) established specifications.  Specifically, *** 1
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, *** 1
15901 21 CFR 111.83(b)(3) Reserve sample - retained   You did not retain reserve samples for the required time.  Specifically, *** 1
15918 21 CFR 111.95(a)  Records - production, process control:  electronic  Your electronic records for your production and process control system do not comply with the electronic records requirements.  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
15924 21 CFR 111.95(b)(5) Documentation - exempted product specification met  You did not make and keep documentation for why component and in-process testing, examination, monitoring or other information will ensure that an exempted product specification is met, without verification through periodic testing of the finished batch.  Specifically, *** 1
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, *** 1
15949 21 CFR 111.110(a) QC-Laboratory control processes; production, process control Your quality control operations did not include reviewing and approving laboratory control processes associated with the production and process control system.  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
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, *** 1
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, *** 1
15962 21 CFR 111.113(b)(1) Quality control - label; master manufacturing record Your quality control personnel did not reject the label when there was a deviation or unanticipated occurrence during the production and in-process control system that could lead to the use of a label not specified in the master manufacturing record.  Specifically,  *** 1
15970 21 CFR 111.120 Quality control operations - components, packaging, labels You do not have quality control operations for [components] [packaging] [labels] before use in the manufacture of a dietary supplement.  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
15987 21 CFR 111.123(b)(3)   Quality control - batch released, adulteration Your quality control personnel approved and released for distribution a batch of dietary supplement that was not manufactured, packaged, labeled, or held under conditions to prevent adulteration.  Specifically, *** 1
15992 21 CFR 111.127(b)   Quality control operations - packaging; quarantine Your quality control operations for packaging did not include approving and releasing from quarantine, prior to use, products you receive for packaging.  Specifically, *** 1
15993 21 CFR 111.127(b)   Quality control operations - labeling; quarantine Your quality control operations for labeling did not include approving and releasing from quarantine, prior to use, products you receive for labeling.  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
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, *** 1
16009 21 CFR 111.140(a)   Records - quality control operations: 1 year, 2 years You did not keep the records required for your quality control operations for the required time period.  Specifically, *** 1
16022 21 CFR 111.140(b)(3)(iv)   Material review, disposition, follow-up; identification  Your documentation of your material review and disposition decision and follow-up did not include identification of the action taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence.  Specifically, *** 1
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, *** 1
16044 21 CFR 111.503   Written procedures - returned dietary supplement; salvaged  You did not [establish] [follow] written procedures for when a returned dietary supplement may be salvaged.  Specifically, *** 1
16050 21 CFR 111.525(a) Returned dietary supplement - specifications  You did not ensure that a returned dietary supplement that was reprocessed 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
16069 21 CFR 111.35(b)(1)(iii) Procedures contact surfaces; maintaining, cleaning, sanitize You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.  Specifically, *** 1
16085 21 CFR 111.75(c)(3)  Specifications met limits on contamination ; basis   You did not provide adequate documentation of your basis for determining that compliance with the specification[s] you selected for the limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement will ensure that the finished batch of dietary supplement will not be adulterated as a result of such contamination. Specifically, ***  1
16090 FDCA 417(d)(1)(A) Report data elements You did not include in a reportable food report [your food facility registration number(s)] [the date on which the food was determined to be a reportable food] [a description of the food] [the quantity or amount of the food] [the extent and nature of the adulteration] [the results of your investigation] [the disposition of the article of food] [product information typically found on packaging].  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
16120 21 CFR 118.4 Written SE plan lacks required elements Your written SE prevention plan lacks appropriate SE prevention measures.  Specifically,*** 1
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,*** 1
16138 21 CFR 118.4(c)(1) Monitoring for rodents The presence of rodents is not monitored by appropriate monitoring methods.  Specifically,*** 1
16140 21 CFR 118.4(c)(2) Monitoring for flies The presence of flies is not monitored by appropriate monitoring methods. Specifically,*** 1
16179 21 CFR 118.8(a) Method to be used, environmental samples For testing to detect SE in environmental samples, you did not have the sample testing conducted by the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses." most current edition, or an equivalent method in accuracy, precision and sensitivity in detecting SE.  Specifically,*** 1
16184 21 CFR 118.9 Lack of supervisory personnel You do not have one or more supervisory personnel who are responsible for ensuring compliance with each farm's SE prevention plan.  Specifically,*** 1
16206 21 CFR 118.10(b)(3) Signature and date on SE plans Your written SE plan does not [bear a date] [carry the signature(s) and not the initials of the person(s) who administer the plan].  Specifically,*** 1
16232 21 CFR 118.11(f) 60 day updates You failed to submit an update to a registration within 60 calendar days of a change to previously submitted information.  Specifically,*** 1
16272 21 CFR 700.25(c) Tamper-resistant feature, vaginal product The identifying characteristic of the tamper-resistant feature of the retail package for a non-aerosol cosmetic vaginal product is not referred to in the labeling statement of the package. Specifically, ***

 
1
16290 21 CFR 113.100(c)(1) TID: accuracy record; identity, tag, seal A record of the accuracy of a temperature-indicating device did not include a reference to the tag, seal, or other means of identity.  Specifically, *** 1
16301 21 CFR 113.100(d)(3) Accuracy record: outside facility, traceability A record of a reference device accuracy test conducted by an outside facility did not include a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentation regarding the traceability of the accuracy to a National Institute of Standards and Technology or other national metrology institute standard.  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
16308 21 CFR 113.40(a)(1)(iv) Still steam retorts: TID not accurate to 1 ?F A temperature-indicating device was not accurate to 1 ?F (0.5 ?C).  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
16317 21 CFR 113.40(a)(1)(iii) Still Retorts: TID defective, could not be adjusted A temperature-indicating device was defective or could not be adjusted to an accurate calibrated reference device.  Specifically, ***  1
16346 21 CFR 113.40(b)(1)(iv) Still water retorts: TID not accurate to 1 ?F A temperature-indicating device was not accurate to 1 ?F (0.5 ?C).  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
16368 21 CFR 113.40(c)(1)(iv) Continuous agitating retorts: TID not accurate to 1?F A temperature-indicating device was not accurate to 1?F (0.5?C).  Specifically, *** 1
16376 21 CFR 113.40(c)(2)(ii) Digital record, intervals insufficient A temperature-recording device that creates a digital record did not record the temperature at intervals that will assure that the parameters of the process time and process temperature were met.  Specifically, *** 1
16450 21 CFR 113.40(g)(1)(i)(A)(1) TID design, electromagnetic interference, environmental A temperature-indicating device was not designed to ensure that the accuracy was not affected by [electromagnetic interference] [environmental conditions].  Specifically, *** 1
16463 21 CFR 113.40(g)(1)(i)(B)(2) Recorder: Digital records - intervals insufficient A temperature-recording device that creates a digital record did not record the temperature at intervals that would assure that the parameters of the process time and process temperature were met.  Specifically, *** 1
16495 FDCA 601(c) Insanitary conditions; injurious to health Your cosmetic was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.  Specifically, *** 1
16500 21 CFR 129.35(a)(3)(i) E. coli follow-up, eliminate, prevent reoccurrence You did not take appropriate measures to rectify or otherwise eliminate the cause of Escherichia coli contamination of your [product] [operations] source water [in a manner sufficient to prevent its reoccurrence].  Specifically, *** 1
16508 21 CFR 129.80(f) Container sample results Your container sample results indicated [that more than one sample exceeded more than one bacteria per milliliter of capacity or one colony per square

centimeter of surface area] [the presence of coliform organisms].  Specifically, ***
1
17004 FDCA 402(a) Food Field Exam During a field examination of food products at your facility the following [was] [were] observed: 1
18140 21 CFR 117.20(b) Plant Construction and Design Your plant was not [constructed] [designed] to facilitate maintenance and sanitary operations.  Specifically, *** 1
18141 21 CFR 117.35(a)

 
Sanitary Operations - Plant Maintenance You did not maintain your plant [in a clean and sanitary condition] [in repair].  Specifically, *** 1
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, *** 1
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, ***  1
18148 21 CFR 117.37

 
Sanitary Facilities and Control Your plant did not have adequate sanitary facilities and accommodations.  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
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, *** 18
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, *** 14
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, *** 13
12416 21 CFR 1271.260(e) Storage temperatures recorded, maintained Storage temperatures of HCT/Ps were not [recorded] [maintained].  Specifically, *** 12
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, *** 10
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, *** 8
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, *** 8
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, *** 8
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, *** 7
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, *** 7
12247 21 CFR 1271.55(d)(2) Accurate, indelible, legible Donor eligibility records are not [accurate] [indelible] [legible].  Specifically, *** 6
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, *** 6
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, *** 6
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, *** 5
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, *** 5
12286 21 CFR 1271.80(b) Specimen collections not  timely Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.  Specifically, *** 5
12365 21 CFR 1271.195(d) Documentation not maintained Documentation of environmental control and monitoring activities was not maintained.  Specifically, *** 5
12223 21 CFR 1271.47(b) Review and approval of procedures Donor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation.  Specifically, *** 4
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, *** 4
12356 21 CFR 1271.195(a) Adequate control, proper conditions Environmental conditions existed in which [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease agents] could occur, and [environmental conditions were not adequately controlled] [proper conditions for operations were not provided].  Specifically, *** 4
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, *** 4
12222 21 CFR 1271.47(a) Design of procedures to ensure compliance Procedures were not designed to ensure compliance with the donor eligibility requirements.  Specifically, *** 3
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, *** 3
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, *** 3
12338 21 CFR 1271.180(b) Review and approval-responsible person Procedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation.  Specifically, *** 3
12395 21 CFR 1271.225 Verification/validation Process changes were not [validated] [verified]  to ensure the change does not cause an adverse impact elsewhere in operations.  Specifically, *** 3
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, *** 3
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, *** 3
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, **** 3
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, *** 3
12238 21 CFR 1271.55(b)(1) Statement re: certified testing lab The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.  Specifically, *** 2
12270 21 CFR 1271.65(a) Improper release prevention--storage, I.D. HCT/Ps from ineligible donors are not [stored] [identified] in a manner to prevent improper release.  Specifically, *** 2
12311 21 CFR 1271.160(b)(1) Ensuring appropriate core requirements followed The quality program has not ensured that appropriate procedures related to core CGTP requirements were  [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [approved] [revised].  Specifically, *** 2
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, *** 2
12340 21 CFR 1271.180(d) Adopted from another organization Current standard procedures adopted from another organization were [not verified to be consistent with the requirements of the CGTP regulations] [not appropriate for your operations].  Specifically, *** 2
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, *** 2
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, *** 2
12372 21 CFR 1271.200(c) Calibrated per established schedules Equipment used for [inspection] [measuring] [testing] was not calibrated  according to established schedules.  Specifically, *** 2
12373 21 CFR 1271.200(d) Inspected routinely Equipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to maintenance schedules].  Specifically, *** 2
12384 21 CFR 1271.215 Potential problems with recovery HCT/Ps were not recovered in a way [that does not cause contamination or cross contamination during recovery] [that does not increase the risk of introduction, transmission or spread of communicable disease].  Specifically, *** 2
12401 21 CFR 1271.230(b) Reduced risk representation Written representation that processing methods reduce the risk of transmission of communicable disease by HCT/Ps was not based on a fully validated or verified process.  Specifically, *** 2
12437 21 CFR 1271.270(a) Records incomplete Records [did not identify the person performing the work] [did not show the dates of entries] [were not detailed as necessary to provide a complete history of work performed] [did not relate to the HCT/P involved].  Specifically, *** 2
12454 21 CFR 1271.290(f) Timely informing of consignees Consignees were not informed in writing at or before the time of distribution of an HCT/P, of [the requirements related to HCT/P tracking] [the tracking system you have established and are maintaining].  Specifically, *** 2
12489 21 CFR 1271.90(b)(1) Autologous use only--labeling HCT/Ps for autologous use and for which the donor eligibility determination was not performed were not labeled for autologous use only.  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
12237 21 CFR 1271.55(a)(3) Summary--records used to make determination After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary of the records used to make the donor-eligibility determination.  Specifically, *** 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
12243 21 CFR 1271.55(d)(1) Documentation maintained (general) Documentation was not maintained after the donor-eligibility determination was complete.  Specifically, *** 1
12245 21 CFR 1271.55(d)(1)(ii) Results, interpretation of CD screening Documentation of [the results] [the interpretation] of all donor screening for communicable diseases was not maintained.  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
12271 21 CFR 1271.65(b)(2) Prominently labeled (limited use) HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled.  Specifically, *** 1
12275 21 CFR 1271.65(c) Nonclinical use--label requirements HCT/Ps from ineligible donors which were made available for nonclinical use were not labeled ["For Nonclinical Use Only"] [with the Biohazard legend].  Specifically, *** 1
12280 21 CFR 1271.75(c) Reproductive cells/ tissues- general Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of communicable diseases of the genitourinary tract.  Specifically, *** 1
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, *** 1
12288 21 CFR 1271.80(c) Manufacturer instructions not followed Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.  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
12309 21 CFR 1271.160(a) Program is appropriate for the HCT/Ps A quality program appropriate for the  HCT/Ps manufactured and manufacturing steps performed has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 1
12312 21 CFR 1271.160(b)(2) Procedures for complaints and other information The quality program has not ensured that procedures exist for [receiving] [investigating] [evaluating] [documenting] information relating to core CGTP requirements, including complaints. 1
12315 21 CFR 1271.160(b)(2) Sharing of information (general) The quality program has not ensured that procedures exist for sharing of information pertaining to the possible contamination or communicable disease transmission of HCT/Ps.  Specifically, *** 1
12321 21 CFR 1271.160(b)(3) Problem description, disposition, date et. al. Documentation of corrective actions did not include [a description of the HCT/Ps] [the disposition] [the nature of the problem] [the description of the corrective action] [the date of the corrective action].  Specifically, *** 1
12324 21 CFR 1271.160(b)(6) Deviations--Investigation, documenting, trending The quality program does not include [the investigation] [the documentation] [the trending] [the reporting] of HCT/P deviations relating to core CTGP requirements.  Specifically, *** 1
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, ***  1
12329 21 CFR 1271.160(d) Documentation/approval prior to implementation Computer software [validation] [verification] activities and results have not been [documented] [approved] prior to implementation.  Specifically, *** 1
12332 21 CFR 1271.170(b) Qualifications lacking Personnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions.  Specifically, *** 1
12337 21 CFR 1271.180(a) Design adequate to bar spread of CD's Procedures were not designed to prevent circumstances that increase the risk of communicable disease introduction, transmission and spread through the use of HCT/Ps.  Specifically, *** 1
12342 21 CFR 1271.190(a) Size, construction, location--prevent mix-ups etc. Facilities were not of suitable [size] [construction] [location] to [prevent contamination of HCT/Ps with communicable disease agents] [ensure the orderly handling of HCT/Ps without mix-ups].  Specifically, *** 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
12361 21 CFR 1271.195(b) Periodic inspection Environmental control systems are not periodically inspected to verify adequate and proper function.  Specifically, *** 1
12362 21 CFR 1271.195(b) Corrective actions Appropriate corrective actions were not taken related to the inspections of environmental control systems.  Specifically, *** 1
12364 21 CFR 1271.195(c) Monitoring-microorganisms where appropriate Environmental conditions were not monitored for microorganisms.  Specifically, *** 1
12369 21 CFR 1271.200(b) Procedures inadequate Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [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
12385 21 CFR 1271.150(c)(2) Responsibility for review before distribution HCT/Ps were determined to meet all release criteria and made available for distribution without review of [manufacturing] [tracking] records to determine that all applicable requirements were met.  Specifically, *** 1
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, *** 1
12389 21 CFR 1271.220(c) Specified requirements for in-process controls Specified requirements for in-process controls were not met.  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
12405 21 CFR 1271.250(a) Controlling the labeling of HCT/Ps Procedures to control the labeling of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 1
12408 21 CFR 1271.250(c) All labeling requirements met Labeling procedures did not ensure that HCT/Ps are labeled in accordance with all labeling requirements.  Specifically, *** 1
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, *** 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
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, *** 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
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
12435 21 CFR 1271.270(a) Records maintained concurrently Records were not maintained concurrently with the performance of each step.  Specifically, *** 1
12441 21 CFR 1271.270(c) Back-up of electronic records Records stored on electronic systems are not backed up.  Specifically, *** 1
12469 21 CFR 1271.350(a)(1) Adverse reaction reporting to FDA Adverse reactions which involved a communicable disease related to an HCT/P made available for distribution and were fatal or life threatening, resulted in permanent impairment or damage to the body, or necessitated medical or surgical intervention, were not reported to FDA.  Specifically, *** 1
12470 21 CFR 1271.350(a)(2) 15 day reporting timeframe Adverse reactions were not reported to FDA using form FDA 3500A within 15 calendar days of initial receipt of information.  Specifically, *** 1
12490 21 CFR 1271.85(b)(1) Cell-associated CD  Donors of leukocyte-rich cells or tissues were not tested for cell-associated communicable diseases.  Specifically, *** 1
15020 21 CFR 1271.200(e) Documentation of maintenance and cleaning Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained.  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, *** 51
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, ***  18
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, *** 14
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, *** 9
6569 21 CFR 1250.33(b) Equipment kept clean Failure to keep all equipment clean.  Specifically, *** 9
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, *** 8
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, *** 8
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, *** 6
6591 21 CFR 1250.42(a) Backflow protection A water system not protected against backflow.  Specifically, *** 6
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, *** 6
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, *** 6
7089 21 CFR 1250.82(d) Identification marks on tanks and piping Not all [tanks] [piping] bear clear marks of identification.  Specifically, *** 6
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, *** 6
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, *** 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, *** 4
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, *** 4
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, *** 4
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, *** 3
6572 21 CFR 1250.34 Thermometers Failure to equip each refrigerator with a thermometer located in the warmest region thereof.  Specifically, *** 3
7034 21 CFR 1250.65 Pooling Drainage at places where water or food supplies are loaded into or removed from conveyances is inadequate to prevent pooling.  Specifically, *** 3
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, *** 3
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, *** 2
6561 21 CFR 1250.32(b) Clean hands Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment].  Specifically, *** 2
6580 21 CFR 1250.38(b) Signs Signs directing food-handling employees to wash their hands after each use of toilet facilities are not [posted] [readily observable by such 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
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
7037 21 CFR 1250.67 Outlets for non-potable water Outlets for non-potable water have not been provided with fittings different from those provided for outlets for potable water.  Specifically, *** 2
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, *** 2
7039 21 CFR 1250.67 Bulk ice Equipment used to [store] [wash] [handle] [deliver] bulk ice intended for [the cooling of drinking water or other beverages] [food preservation purposes] is not [constructed so as not to become a factor in the transmission of communicable diseases] [used for no other purposes].  Specifically, *** 2
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, *** 2
7054 21 CFR 1250.75(b) Soil cans and removable containers Failure to [thoroughly] clean [soil cans] [removable containers] prior to return to use.  Specifically, *** 2
7118 21 CFR 1250.90 Clean condition Toilet and lavatory [equipment] [spaces] not maintained in a clean condition.  Specifically, *** 2
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, *** 1
6522 21 CFR 1240.80 Unapproved watering point Potable water has been obtained from a watering point not approved by the Commissioner of Food and Drugs.  Specifically, *** 1
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, *** 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
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, *** 1
7056 21 CFR 1250.75(c) Persons handling soil cans and other containers Persons who have handled [soil cans] [containers which have come in contact with human wastes] do not [wash their hands thoroughly with soap and warm water] [remove any garments which have become soiled with human wastes] before engaging in work connected with the [loading] [unloading] [transporting] [handling] of [food] [water] [ice].  Specifically, *** 1
7081 21 CFR 1250.82(a) Separate systems The potable water system is [not separate and distinct from other water systems] [used for other purposes].  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
Cite Id Reference Number Short Description Long Description Frequency
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, *** 7
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, *** 6
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, *** 6
5940 21 CFR 1030.10(c)(3)(i) tests--errors and uncertainties accounted for Tests for microwave oven compliance failed to account for all measurement errors and uncertainties to ensure that the equivalent plane-wave power density did not exceed the required limit.  Specifically, *** 6
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, *** 3
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, *** 2
5472 21 CFR 1020.30(k) Compliance measurements--diagnostic source assembly Compliance for radiation leakage from the diagnostic source assembly was not determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.  Specifically, *** 2
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, *** 2
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, *** 1
5017 21 CFR 1003.21(a) Incomplete notification of affected persons Your notification to dealers, distributors, and purchasers regarding an electronic product, upon discovery of a [defect] [noncompliance with a Federal standard], lacked the following information: [identification of the product] [a description of the defect] [a description of the manner of noncompliance] [instructions concerning use of the product pending correction of the problem] [a clear evaluation in non-technical terms of hazards related to the problem] [a statement that you would, without charge, remedy the problem in accordance with a plan to be approved by the Secretary of Heath and Human Services, the details of which would be included in a subsequent communication].  Specifically, *** 1
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, *** 1
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, *** 1
5042 21 CFR 1010.3(a) ID label or tag An identification 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, *** 1
5043 21 CFR 1010.3(a)(1) ID label lacks name and address An identification label failed to provide the name and address of the [manufacturer] [individual or company under whose name the product was sold].  Specifically, *** 1
5046 21 CFR 1010.3(a)(2)(ii) Manufacture date abbreviated or unapproved date coding The date of manufacture provided on the identification label is [not clear and legible] [abbreviated] [not stated in the prescribed manner].  Specifically, *** 1
5137 21 CFR 1040.10(c)(1)  Classification error of laser product Each laser product was not classified into Class I, IIa, II. IIIa, IIIb, or IV in accordance with definitions set forth in the CFR]  [does not have its product classification based on the highest accessible emission level(s) of laser radiation to which human access is possible during operation in accordance with the CFR sections on admissible emission limits, tests for determination of compliance and protective housing requirements].  Specifically, *** 1
5143 21 CFR 1040.10(f)(1) Protective housing Each laser product is not provided with a protective housing that prevents human access during operations to laser and collateral radiation that exceeds the limits of Class I and table VI, respectively, wherever and whenever such human access is not necessary for the product to perform its intended function(s).  Specifically, *** 1
5171 21 CFR 1040.10(g)(3) Class IV "Danger" label Each Class IV laser product does not have affixed a label  [bearing the DANGER logotype specified in the regulation] [bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION" in the position specified in the regulation] [bearing the wording "CLASS IV LASER PRODUCT" in the position specified in the regulation].  Specifically, *** 1
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, *** 1
5209 21 CFR 1040.11(a)(3) Aperture label A label bearing the wording: "Laser aperture". is not affixed to the medical laser product, in close proximity to the aperture through which was emitted accessible laser radiation in excess of the accessible emission limits of Class I. Specifically, *** 1
5449 21 CFR 1020.30(h)(1)(ii) Maintenance schedule Failure to provide to the purchasers or others upon request at cost, a schedule of maintenance necessary to keep the x-ray equipment in compliance with the applicable standard.  Specifically, *** 1
5705 21 CFR 1002.31(a) Five year requirement You have not preserved your required record(s) for a period of five years from the date of the record.  Specifically, *** 1
5783 21 CFR 1003.20 Failure to confirm in writing to FDA You did not confirm in writing the notification to the Secretary required by 21 CFR 1003.10(a) for an electronic product which [has a defect] [does not comply with an applicable Federal standard].   Specifically, *** 1
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, *** 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
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, *** 1
Cite Id Reference Number Short Description Long Description Frequency
4185 FDCA 402(a)(4) Record keeping Treatment records were not [maintained] [complete].  Specifically,***  191
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, *** 132
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, *** 56
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, *** 42
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, *** 36
1360 FDCA 501(a)(5) Expired drugs Expired drug(s) were observed in the drug storage area.  Specifically, *** 35
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, *** 29
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, *** 22
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, *** 20
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, *** 14
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, *** 14
1446 FDCA 402(a)(4) Hospital pen Failure to [identify] [segregate] [quarantine] treated animals.  Specifically, *** 14
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, ***
 
13
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, *** 11
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, *** 10
4184 FDCA 501(a)(5) Conditions of use Administration of a drug for conditions not [specified in its labeling] [prescribed].  Specifically, *** 10
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, *** 9
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, *** 9
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, *** 8
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, *** 8
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, *** 7
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, *** 7
1457 FDCA 402(a)(4) Feeding colostrum Feeding colostrum or milk from treated cows to calves intended for slaughter.  Specifically, *** 6
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, *** 6
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, *** 6
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, *** 5
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, *** 5
1765 21 CFR 225.42(b)(6)(i) - (v) 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, ***   4
2093 21 CFR 225.102(b)(2)(i)-(iv) 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 MRF].  Specifically, *** 4
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, ***

 
4
4183 FDCA 501(a)(5) Frequency of administration Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed].  Specifically, *** 4
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, *** 4
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, *** 3
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
1955 21 CFR 225.80(a) Appropriate labeling for medicated feed Medicated feed is not identified by appropriate labeling which provides the user with directions for use which if adhered to, will assure the article is safe and effective for its intended purpose.  Specifically, *** 3
4094 21 CFR 530.11(b) Use in animal feed An approved drug was used in or on an animal feed in a manner not in accordance with the approved labeling. Specifically, *** 3
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, *** 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
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, *** 3
1469 21 CFR 225.20(b)(3) Pest access minimized The building is not constructed to minimize access by [rodents] [birds] [insects] [pests].  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
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, *** 2
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, *** 2
1821 21 CFR 225.58(b)(1) First batch assay No assay was performed on the first batch for the calendar year of medicated feed requiring a medicated feed mill license.  Specifically, *** 2
1850 21 CFR 225.58(d) Assay results out of specification Failure to [investigate] [implement corrective action] [maintain a record on the premises of corrective action] when assay results show medicated feeds [not in accord with label specifications] [not within permissible assay limits].  Specifically,*** 2
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, *** 2
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, ***

 
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
4098 21 CFR 530.20(a)(2)(i) Diagnosis and evaluation of conditions Failure to make a careful diagnosis and evaluation of the conditions for which an approved human or animal drug was to be used in a food-producing animal, contrary to the drug's labeling.  Specifically, *** 2
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, *** 2
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, *** 2
4113 21 CFR 530.12(e) Withdrawal, withholding, or discard time Failure to provide labeling containing [withdrawal] [withholding] [discard] time as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.  Specifically, *** 2
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, *** 2
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, *** 2
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, *** 2
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, *** 2
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, ***  2
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, *** 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
1447 FDCA 402(a)(4) Feeding areas Failure to adequately clean feed and water containers to prevent cross-contamination of medicated and non-medicated feeds and liquids.  Specifically, *** 1
1470 21 CFR 225.20(b)(4) Space and lighting for operations Buildings do not provide adequate [space] [lighting] for [receipt, control, and storage of components] [component processing] [medicated feed manufacturing] [packaging and labeling] [storage of containers and packaging materials] [storage of  labeling] [storage of finished products] [routine maintenance of equipment].  Specifically, *** 1
1491 21 CFR 225.30(b)(2) Maintenance reasonably clean & orderly Equipment is not  maintained in a reasonably clean and orderly manner.  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
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
1930 21 CFR 225.65(b)(3) Sequential production Sequential production of medicated feeds is not done on a predetermined basis designed to prevent unsafe contamination of feeds with residual drugs.  Specifically, *** 1
1951 21 CFR 225.80(b)(1) Receipt, handling, and storage The [labels] [labeling] [placards] are not [received] [handled] [stored] in a manner to prevent mix-ups and assure correct labeling is employed for the medicated feed.  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
2189 21 CFR 225.110(b)(1) Distribution record elements Distribution record(s) for medicated feeds fail to include the [date of shipment] [name and address of purchaser] [quantity shipped] [name of the medicated feed] [lot, control number, date of manufacture, or other suitable identification].  Specifically, *** 1
2232 21 CFR 225.115(b)(1) Maintaining records of complaints The original or copy of a record of each oral or written complaint received relating to the safety and effectiveness of the product produced is not maintained on the premises.  Specifically, *** 1
2233 21 CFR 225.115(b)(1) Records of oral or written complaints The record of each oral or written complaint relating to the safety and effectiveness of a  medicated feed  fails to include the [date of the complaint] [complainant's name] [complainant's address] [name and lot or control number or date of manufacture] [specific details of the complaint] [correspondence from the complainant and/or memoranda of conversations] [description of all investigations made by the manufacturer] [method of disposition of the complaint]. Specifically, *** 1
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, *** 1
4109 21 CFR 530.12(a) Name and address - drug dispensed by pharmacist Failure to provide labeling showing the [name of the prescribing veterinarian] [name and address of the dispensing pharmacist] for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.  Specifically, *** 1
4116 21 CFR 530.13(b)(2) Approved drug available Compounding a drug from an approved human or animal drug, where there already exists an approved human or animal drug which would appropriately treat the condition diagnosed.  Specifically, *** 1
4118 21 CFR 530.13(b)(3) Outside of scope of professional practice Compounding  of an approved drug for use in an extralabel manner was not performed by a licensed [pharmacist] [veterinarian] within the scope of a professional practice.  Specifically, *** 1
4119 21 CFR 530.13(b)(4) Inadequate procedures and processes Failure to follow adequate procedures and processes to ensure the safety and effectiveness of a compounded animal drug.  Specifically, *** 1
4131 21 CFR 589.2000(c)(1)(i) Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants."  Specifically, *** 1
4158 21 CFR 225.80(b)(4) Label stock review Label stock is not [reviewed periodically] [discarded when discontinued labels are found].  Specifically, *** 1
4297 21 CFR 226.42(a) Components receiving, testing, handling, et. al. Drug components used in the manufacture and processing of Type A medicated articles are not [received] [examined or tested] [stored] [handled] [controlled] in a manner to maintain the [integrity] [identification] of such articles.  Specifically, *** 1
4454 21 CFR 225.20(a) Facilities features  The features of the facility necessary for the proper manufacture of medicated feeds fail to provide for [ease of access to structures and equipment for routine maintenance] [ease of cleaning of equipment and work areas] [facilities to promote personal hygiene] [structural conditions for control of vermin and pests] [adequate space for the orderly receipt and storage of drugs and feed ingredients] [adequate space for the controlled flow of materials through the processing and manufacturing operations] [equipment necessary for the accurate packaging and delivery of a medicated feed of specified labeling and composition].  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
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
13578 21 CFR 589.2001(c)(1) Comply with 589.2001 Failure to comply with all applicable requirements in the regulations regarding cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy (BSE).  Specifically,*** 1

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