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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FY 2006 Inspectional Observation Summaries

 

 

Number of 483s issued from the System* 

Inspections ending between 10/1/2005 12:00:00 AM and 9/30/2006 12:00:00 AM

Center Name483s issued
Foods2452
Devices887
Drugs649
Incidental text418
Bioresearch monitoring286
Veterinary medicine202
Biologics299
Parts 1240 and 1250204
Human tissue for transplantation86
Radiological health2
Special requirements12
Sum Product Area 483s from System*5497
Actual Total in system 483s**4849

* 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.

Back to Inspectional Observation Summaries

 


 

Foods

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Foods90521 CFR 123.6(b)364HACCP plan implementationYou did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan. Specifically, ***
152421 CFR 123.11(b)323Sanitation monitoringYou 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, ***
156021 CFR 110.35(c)263Lack of effective pest exclusionEffective measures are not being taken to [exclude pests from the processing areas] [protect against the contamination of food on the premises by pests]. Specifically, ***
90421 CFR 123.6(b)258No HACCP planYou do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur. Specifically, ***
152521 CFR 123.11(c)250Sanitation RecordsYou 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, ***
1272021 CFR 1.225249Not registeredYour food facility is not registered as required. Specifically, ***
94521 CFR 123.12(a)(2)238Importer verificationYou 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, ***
90821 CFR 123.6(d)210Signed and datedYour HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually]. Specifically, ***
600421 CFR 123.6(c)(4)204Monitoring - adequacyYour HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit. Specifically***
96121 CFR 123.6(c)(3)195Critical limitsYour 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,
600821 CFR 123.8(a)(3)186Verification - record review - frequencyYou 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, ***
96021 CFR 123.6(c)(2)165Critical control pointsYour HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards. Specifically, ***
142221 CFR 110.20(b)(4)145Floors, walls and ceilingsThe 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, ***
155221 CFR 110.35(a)140Buildings/sanitaryFailure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, ***
602021 CFR 123.9(a)139Records - contentYour 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, ***
96321 CFR 123.6(c)(5)136Corrective action planYour 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***
155321 CFR 110.35(a)135Buildings/good repairFailure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated. Specifically, ***
130621 CFR 110.20(b)(7)131ScreeningFailure to provide adequate screening or other protection against pests. Specifically, ***
128721 CFR 110.20(a)(1)119Harborage areasFailure 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, ***
602121 CFR 123.10119HACCP training or qualificationNo one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience. Specifically, ***
95921 CFR 123.6(c)(1)117Food safety hazardsYour HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, ***
169521 CFR 110.80(b)(2)113Manufacturing conditionsFailure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination]. Specifically, ***
93321 CFR 123.8(a)(2)(ii)110Calibration - adequacyYour process monitoring equipment is not calibrated to ensure that it reads accurately. Specifically, ***
238621 CFR 110.80(a)(1)101StorageFailure to store raw materials in a manner that [protects against contamination] [minimizes deterioration]. Specifically, ***
600121 CFR 123.11(b)98Sanitation monitoring documentationYour sanitation control records do not accurately document the conditions or practices observed at your firm. Specifically***
155421 CFR 110.35(a)95Cleaning and sanitizing operationsFailure 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, ***
170121 CFR 110.80(b)(7)94Equipment, containers, utensilsFailure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold] [store] food in a manner that protects against contamination. Specifically, ***
142421 CFR 110.20(b)(4)92Drip and condensateThe plant is not constructed in such a manner as to prevent [drip] [condensate] from contaminating [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
140521 CFR 110.10(b)(6)89Failure to wearFailure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate. Specifically, ***
99021 CFR 110.10(b)(3)84Not washed/sanitized when appropriateEmployees 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, ***
100721 CFR 110.10(b)(9)83Precautions against contamination--micro, foreign substancesFailure to take necessary precautions to protect against contamination of [food] [food contact surfaces] [food packaging systems] with [microorganisms] [foreign substances]. Specifically, ***
142721 CFR 110.20(b)(5)81Safety lighting and glassFailure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food. Specifically, ***
600521 CFR 123.6(c)(6)76Verification procedures - adequacyYour 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, ***
117321 CFR 110.40(f)75Q.C. instrument accuracy, maintenanceInstruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms are not [accurate] [adequately maintained]. Specifically,***
161521 CFR 110.9374Storage/transportation of finished goods (contamination)Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination. Specifically, ***
601821 CFR 123.7(a)74Corrective action per predetermined planYou did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]. Specifically,***
239221 CFR 110.80(b)(1)73Maintenance of equip., utensils, and finished food packagingFailure to maintain [equipment] [utensils] [finished food containers] in an acceptable condition through appropriate cleaning and sanitizing. Specifically, ***
168921 CFR 110.8072Reasonable precautionsAll reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, ***
993021 CFR 120.6(c)72SSOP recordsYou 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, ***
365921 CFR 110.37(e)(3)70Hand dryingLack of a sanitary towel service or suitable hand drying devices. Specifically, ***
100621 CFR 110.10(b)(8)67Personal food/drink/tobaccoEmployees were observed to be [eating food] [chewing gum] [drinking beverages] [using tobacco] in areas where [food is exposed] [equipment or utensils are washed]. Specifically, ***
155621 CFR 110.35(b)(2)67Storage requirementsFailure 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, ***
93121 CFR 123.8(d)66Verification - recordkeepingYou do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing]. Specifically, ***
156221 CFR 110.35(d)66Failure to clean - generalFailure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food. Specifically, ***
601521 CFR 123.6(c)(6)64Verification procedures - none/frequencyYour 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, ***
91321 CFR 123.8(a)(1)58Reassessment of HACCP planYour verification procedures do not include, at a minimum, reassessment of the HACCP plan [at least annually] [whenever modifications to the process are made]. Specifically, ***
129221 CFR 110.20(b)(1)58Sufficient spaceFailure 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, ***
159721 CFR 110.37(b)(3)58As source of contaminationPlumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils]. Specifically, ***
158121 CFR 110.37(e)55Running water at suitable temperatureHand-washing facilities lack running water of a suitable temperature. Specifically, ***
112621 CFR 110.40(a)54Precluding contaminantsThe [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food with [lubricants] [fuel] [metal fragments] [contaminated water] [contaminants]. Specifically, ***
600721 CFR 123.9(a)52Records entries - timingProcessing or other information was not [always] entered on your records at the time it was observed. Specifically, ***
90121 CFR 123.6(a)51Hazard analysisYou 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, ***
366121 CFR 110.37(e)(5)51SignsLack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate. Specifically, ***
994121 CFR 120.8(a)51No HACCP planYou do not have a written HACCP plan that outlines controls for one or more food safety hazards that are reasonably likely to occur. Specifically, ***
90621 CFR 123.6(b)50HACCP plan locationYour HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery product processed]. Specifically, ***
117221 CFR 110.40(e)50Lack of thermometerLack 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, ***
600621 CFR 123.6(c)(7)49Records values/observationsYour monitoring records do not contain the actual values and observations obtained during monitoring. Specifically, ***
112521 CFR 110.40(a)48Materials and workmanshipThe [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance]. Specifically, ***
140221 CFR 110.10(b)(4)48Unsecured jewelryEmployees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers]. Specifically, ***
169621 CFR 110.80(b)(3)46Holding foods - refrigerate/freeze/heatFailure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated. Specifically, ***
159921 CFR 110.37(b)(5)45Backflow preventionLack of backflow protection from piping systems that discharge [waste water] [sewage]. Specifically, ***
447021 CFR 108.25(c)(2)44Process filingFailure to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container size. Specifically, ***
993521 CFR 120.7(a)44No hazard analysisYou 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, ***
365221 CFR 110.37(e)(1)43Suitable locationsFailure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed. Specifically, ***
157121 CFR 110.35(d)(5)42Shown to be effectiveThe [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not been shown to provide adequate [cleaning] [sanitizing treatment]. Specifically, ***
365821 CFR 110.37(e)(2)42Hand cleaning and sanitizing preparationsLack of effective hand [cleaning] [sanitizing] preparations. Specifically, ***
601921 CFR 123.8(a)(2)42Ongoing verification - complaints, calibration recordsYour 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, ***
993121 CFR 120.6(b)42Sanitation monitoringYou 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, ***
995821 CFR 120.12(c)42Signed/datedYour [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, ***
365421 CFR 110.37(d)(1)41MaintainedFailure to maintain toilet facilities in a sanitary condition. Specifically, ***
98521 CFR 110.10(b)(1)40Suitable outer garmentsSuitable outer garments are not worn that protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, ***
601021 CFR 123.8(a)(3)(i)40Monitoring record review adequacyYour 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, ***
140621 CFR 110.10(b)(6)39Effective use of hair restraintFailure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner. Specifically, ***
106621 CFR 110.40(b)37Seams on food contact surfacesFailure 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, ***
157021 CFR 110.35(d)(5)36Safe and adequate for useSanitizing agents are [inadequate] [unsafe] under conditions of use. Specifically, ***
169821 CFR 110.80(b)(5)36Work-in-progressFailure to handle work-in-progress in a manner that protects against contamination. Specifically, ***
170221 CFR 110.80(b)(8)36Metal / extraneous materialsFailure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food. Specifically, ***
602221 CFR 123.12(c)36Lack of recordsYou 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, ***
95021 CFR 123.12(d)35Determination of complianceYou have not provided evidence that the [fish] [fishery products] you import have been processed under conditions that comply with the Seafood HACCP regulation. Specifically, ***
100521 CFR 110.10(b)(7)35Storage of personal itemsPersonal [clothing] [belongings] were stored in an area where [food is exposed] [equipment or utensils are washed]. Specifically, ***
1273421 CFR 120.12(a)35Required records not maintainedYou 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, ***
308021 CFR 114.8333Scheduled process establishmentA 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, ***
601621 CFR 123.6(c)(7)33Records systemYour HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points. Specifically, ***
129321 CFR 110.20(b)(2)32Contamination 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, ***
157821 CFR 110.37(f)32Odor, attractant for pests, harborageThe [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, ***
308621 CFR 114.100(b)32Maintenance of processing and production recordsFailure 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, ***
993221 CFR 120.6(a)32No SSOP or not implementedYou 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, ***
1274221 CFR 120.8(a)32HACCP plan not implementedYou did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan. Specifically, ***
93221 CFR 123.7(d)31Corrective action documentationYou do not have records that document corrective actions that were taken. Specifically, ***
156521 CFR 110.35(d)(3)29Non-food-contact surfaces (S)Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination. Specifically, ***
308521 CFR 114.100(a)29Raw materials, packaging, finished productRecords 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, ***
140321 CFR 110.10(b)(4)28Hand jewelry - remove/coverFailure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods where food is being manipulated by hand. Specifically, ***
142621 CFR 110.20(b)(5)28Adequate lightingFailure 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, ***
601421 CFR 123.6(c)(2)26Monitoring - noneYour 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,
995521 CFR 120.11(a)(1)26Verification activitiesYour 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, ***
1274921 CFR 120.8(b)(6)26Verification procedures - none/frequencyYour HACCP plan does not list the verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is being implemented. Specifically, ***
1275521 CFR 120.11(a)(1)(iv)26Records review signedYour 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, ***
128921 CFR 110.20(a)(3)25DrainageLack of adequate drainage of areas which may contribute to contamination of food by [seepage] [foot-borne filth] [providing a breeding place for pests]. Specifically, ***
170921 CFR 110.80(b)(13)25Filling, assembling, packing controlsFailure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated. Specifically, ***
998421 CFR 120.13(a)25Training requirementsDO NOT CITE. See Notes for more information.

 
91821 CFR 123.8(a)23Verification - reviewers qualificationsThe [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, ***
160221 CFR 110.37(a)23Suitable temp. and pressureFailure 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, ***
365621 CFR 110.37(d)(3)23Self-closing doorsToilet facilities lack self-closing doors. Specifically, ***
447921 CFR 108.25(e)23Recall proceduresFailure 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, ***
159821 CFR 110.37(b)(4)22DrainagePlumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage. Specifically, ***
364321 CFR 110.10(b)(5)22Glove conditionGloves used in food handling are not maintained in an intact, clean, and sanitary condition. Specifically, ***
992821 CFR 120.12(b)22General records requirementsYour 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, ***
1274721 CFR 120.8(b)(3)22Critical limitsYour 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, ***
106721 CFR 110.40(c)21Non food-contact equipment in processing areaNon food-contact equipment in [manufacturing] [food handling] areas is not constructed so that it can be kept in a clean condition. Specifically, ***
142921 CFR 110.20(b)(6)20Fans/air blowing equipmentFailure 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, ***
600921 CFR 123.8(a)(3)(iii)20Verification - record review - calibrationYou did not review [some of] your calibration records within a reasonable time after the records were made. Specifically, ***
446421 CFR 108.25(c)(1)19RegistrationFailure 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, ***
993621 CFR 120.7(a)19Hazard analysis - elementsYour 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, ***
307821 CFR 114.80(b)18Code - required elementsEach container is not marked with an identifying code specifying the [establishment where the product was packed] [product contained therein] [year] [date] [packing period]. Specifically, ***
601721 CFR 123.7(c)18Corrective action per regulationYou 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, ***
993421 CFR 120.6(a)18SSOP does not addressYour sanitation standard operating procedure does not address [the safety of the water that comes into contact with food or food contact surfaces or that is used to manufacture ice] [the condition and cleanliness of food contact surfaces] [the prevention of cross-contamination from insanitary objects] [the maintenance of hand washing, hand sanitizing, and toilet facilities] [the protection of food, food packaging material, and food contact surfaces from adulteration with contaminants] [the proper labeling, storage, and use of toxic compounds] [the control of employee health conditions that could result in microbiological contamination of the food, food packaging materials, and food contact surfaces] [the exclusion of pests from the food plant]. Specifically, ***
994721 CFR 120.11(b)18HACCP plan - failure to validateYou 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, ***
1274521 CFR 120.8(b)(1)18Food hazardsYour HACCP plan does not list all food hazards that are reasonably likely to occur. Specifically, ***
97521 CFR 123.9(b)(1)17Record retentionYour [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period. Specifically, ***
239321 CFR 110.80(b)(1)17Teardown equipment/thorough cleaningFailure to take apart equipment as necessary to ensure thorough cleaning. Specifically, ***
307321 CFR 114.80(a)(2)17pH testingFailure to exercise sufficient control including [frequent testing] [recording of results] so that the finished equilibrium pH values are not higher than 4.6. Specifically, ***
112821 CFR 110.40(a)16Installation and maintenance of equipment (S)Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces]. Specifically, ***
307121 CFR 114.80(a)(1)16Scheduled processAcidified food is not manufactured in accordance with the scheduled process. Specifically, ***
364721 CFR 110.10(c)16Training of handlers and supervisorsAppropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors]. Specifically, ***
366321 CFR 110.40(e)16Lack 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, ***
1274321 CFR 120.8(b)(4)15Monitoring - adequacyYour HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure compliance with the critical limits. Specifically, ***
118421 CFR 110.35(e)14Storage 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, ***
159621 CFR 110.37(b)(2)14Convey sewagePlumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey sewage and liquid disposable waste from the plant. Specifically, ***
306221 CFR 114.1014PersonnelOperators 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, ***
371221 CFR 110.9314Storage/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, ***
993921 CFR 120.7(c)14Consideration of hazardsIn 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, ***
995421 CFR 120.11(a)(1)(iv)14Record review - CCP, CAYou 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, ***
1274621 CFR 120.8(b)(2)14Critical control pointsYour HACCP plan does not list the critical control points for each of the identified food hazards. Specifically, ***
112921 CFR 110.40(a)13Food-contact - corrosion resistantLack of corrosion-resistant food contact surfaces. Specifically, ***
171121 CFR 110.80(b)(15)13Proper pH controlsFailure 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, ***
238421 CFR 110.80(a)(7)13Receipt/storage - liquid and dry raw materialsFailure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against contamination. Specifically, ***
238821 CFR 110.80(a)(5)13Holding in bulk or suitable containersFailure to hold [raw materials] [rework materials] [ingredients] in bulk or in suitable containers so as to protect against contamination. Specifically, ***
306721 CFR 114.80(a)13Quality control proceduresAppropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard. Specifically, "***
994321 CFR 120.8(a)13Location and typeYour HACCP plan is not specific to [each location where juice is processed] [each type of juice processed]. Specifically, ***
1275021 CFR 120.8(b)(6)13Validation procedures - none/frequencyYour 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, ***
160121 CFR 110.37(a)12Safe and adequate sanitary qualityFailure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces. Specifically, ***
239421 CFR 110.80(b)(6)12Contamination by raw materials, refuse, other ingredientsFailure to take effective measures to protect finished food from contamination by [raw materials] [refuse] [other ingredients] . Specifically, ***
1275121 CFR 120.8(b)(7)12Recordkeeping systemYour HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical control points. Specifically, ***
92921 CFR 123.8(b)11Verification - corrective actionYou 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, ***
156621 CFR 110.35(d)(4)11Single-service articlesFailure 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, ***
164221 CFR 113.100(b)11Review not signed/datedFailure of the reviewer to [sign or initial] [date] the [processing records] [production records] [recording temperature chart(s)] after the completion of the processing of a low-acid food product. Specifically, ***
365521 CFR 110.37(d)(2)11Good repairFailure to keep toilet facilities in good repair. Specifically, ***
93821 CFR 123.9(c)10Official reviewYou did not make available for official review and copying at reasonable times [all records] [all plans and procedures] required by the regulations. Specifically, ***
109021 CFR 110.40(d)10Holding, conveying, mfg systems - design & constructionLack of appropriate [design] [construction] to enable [holding] [conveying] [manufacturing] systems to be maintained in an appropriate sanitary condition. Specifically, ***
156121 CFR 110.35(c)10Insecticides/rodenticidesUse of [insecticides] [rodenticides] without observing necessary precautions and restrictions to protect against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
176321 CFR 110.35(b)(1)10Safe and adequate for useUse of cleaning compounds and sanitizing agents which are not [free from undesirable microorganisms] [safe and adequate under the conditions of use]. Specifically, ***
176621 CFR 110.35(b)(1)10Unacceptable toxic compoundsStorage 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, ***
236121 CFR 110.8010TestingFailure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, ***
991921 CFR 120.10(a)10Steps to be takenYou did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]. Specifically, ***
995721 CFR 120.12(a)(4)10Records - HACCP systemThe records you maintain to document the ongoing application of your HACCP plan do not include [the monitoring of critical control points and their limits] [corrective actions]. Specifically, ***
996121 CFR 120.24(a)10HACCP plan - microorganism reductionYour 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, ***
98621 CFR 110.10(b)(2)9Personal cleanlinessEmployees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness. Specifically, ***
142521 CFR 110.20(b)(4)9Spacing of equipmentAisles or working spaces between equipment and walls are [obstructed] [of inadequate width]. Specifically, ***
365721 CFR 110.37(d)(4)9Doors opening into processing areasToilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such contamination. Specifically, ***
992921 CFR 120.12(b)(4)9Recorded when observedProcessing and other information is not [always] entered on your records at the time it is observed. Specifically, ***
1274421 CFR 120.8(b)(4)9Monitoring - noneYour 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, ***
169721 CFR 110.80(b)(4)8Preventive control measuresFailure 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, ***
238521 CFR 110.80(a)(1)8Inspection, segregation, handling of raw materialsFailure to [inspect] [segregate] [handle] raw materials to ascertain that they are clean and suitable for processing into food. Specifically, ***
309021 CFR 114.100(d)8Product distributionRecords identifying initial distribution of finished product are not maintained. Specifically, ***
156821 CFR 110.35(d)(2)7Before use and after interruptionFailure 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, ***
164121 CFR 113.100(b)7Review not done/timelyA review of processing and production records by a qualified representative of plant management was not done [within one working day after the completion of the process] [before shipment or release for distribution] to determine [completeness of the records] [whether product was processed as specified by the scheduled process]. Specifically, ***
365321 CFR 110.37(d)7Readily accessibleFailure to provide employees with [readily accessible] [adequate] toilet facilities. Specifically, ***
366221 CFR 110.37(e)(6)7Refuse receptaclesRefuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food. Specifically, ***
600221 CFR 123.11(b)7Sanitation correctionsYou did not correct sanitation deficiencies in a timely manner. Specifically,***
601221 CFR 123.8(a)(3)(iii)7Calibration record review adequacyYour 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, ***
89921 CFR 123.166Process controlsYour HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. Specifically, ***
164321 CFR 113.100(c)6Incomplete informationWritten records of all container closure examinations did not specify [product code] [date of container closure inspection] [time of container closure inspection] [measurements obtained] [corrective actions taken]. Specifically, ***
239621 CFR 110.80(b)(6)6Conveyor transportationFailure to take effective measures to protect food transported by conveyor from contamination. Specifically, ***
366021 CFR 110.37(e)(4)6Devices and fixturesDevices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands. Specifically, ***
992621 CFR 120.14(a)6Importer verificationYou 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, ***
998121 CFR 120.12(b)(4)6Actual valuesYour records do not [always] contain the actual values and observations obtained during monitoring. Specifically, ***
97221 CFR 123.8(a)(1)5Modification HACCP planYou did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate. Specifically, ***
128821 CFR 110.20(a)(2)5Roads/yards/parking lotsFailure to properly maintain [roads] [yards] [parking lots] so that they do not constitute a source of contamination in areas where food is exposed. Specifically, ***
206521 CFR 123.28(c)5Shellstock recordsYou do not maintain records that document the [date of harvest] [location of harvest by State and site] [quantity and type of shellfish received] [date of receipt] [name of the harvester OR registration number of the harvester vessel OR the identification number of the harvester issued by the shellfish control authority]. Specifically, ***
227521 CFR 129.80(g)(2)5Chemical, physical, radiologicalYou do not take and analyze samples of bottled drinking water for [chemical] [physical] [radiological] testing at least annually [for each type of bottled drinking water produced during a day's production run]. Specifically, ***
239121 CFR 110.80(a)(6)5Thawed appropriatelyFailure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated. Specifically, ***
307521 CFR 114.80(a)(4)5Container testingFailure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination. Specifically, ***
308221 CFR 114.895Process deviationFailure 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, ***
309321 CFR 114.895Process deviation evaluation - recordFailure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations]. Specifically, ***
429621 CFR 110.80(a)(5)5Temperature and humidityFailure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming adulterated. Specifically, ***
441921 CFR 110.10(c)5Level 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, ***
991721 CFR 120.10(c)5Corrective action documentationYou do not have records that [fully] document corrective actions that were taken. Specifically, ***
996221 CFR 120.24(b)5Direct treatment - not exempt under 120.24(b)Your treatments intended to achieve a 5-log reduction in the most resistant microorganism of public health significance are not applied directly to the juice, and the exemption for surface treatment of fruit does not apply. Specifically, ***
996421 CFR 120.255Finished product not analyzed for E.coliYou do not [always] analyze your finished juice product for biotype I Escherichia coli. Specifically, ***
1273221 CFR 120.10(a)5Corrective action - predetermined planYour 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, ***
1275421 CFR 120.11(a)(1)(iv)(C)5Calibration, testing - record reviewYour 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, ***
106021 CFR 123.11(a)4SSOP(S)You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP). Specifically, ***
117621 CFR 110.40(f)4Insufficient number of Q.C. instrumentsAn inadequate number of instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms. Specifically,***
119621 CFR 110.10(a)4Employees with illness, lesions, contamination sourceEmployees 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, ***
133021 CFR 113.100(a)4Processing entry missing informationForms used to record processing or production information lack the [product] [code number] [date] [retort or processing system number] [container size] [approximate number of containers per coding interval] [initial temperature] [actual processing time] [mercury-in-glass thermometer readings] [recording thermometer readings] [appropriate processing data]. Specifically, ***
157721 CFR 110.37(f)4Contamination of food, contact surfaces, water supplies, etcThe [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of [food] [food-contact surfaces] [water supplies] [ground surfaces]. Specifically, ***
173421 CFR 113.40(a)(2)4Corresponding with MIGFailure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***
175121 CFR 113.40(a)(8)4Size, fully openBleeders were [smaller than 1/8-inch] [not wide open during the entire process] [not open during come-up-time]. Specifically, ***
236221 CFR 110.804Reject and reworkFood 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, ***
238721 CFR 110.80(a)(1)4Washing and cleaningFailure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination. Specifically, ***
238921 CFR 110.80(a)(5)4Identify reworkFailure to identify material scheduled for rework as such. Specifically, ***
284821 CFR 113.40(g)(1)(i)(b)4Corresponding with MIGFailure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] a known accurate mercury-in-glass thermometer. Specifically, ***
307721 CFR 114.80(b)4Visible codeEach container is not marked with an identifying code permanently visible to the naked eye. Specifically, ***
308821 CFR 114.100(b)4Processing and production - required informationThe [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, ***
308921 CFR 114.100(c)4Process deviations- identification and recordsDepartures 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, ***
364521 CFR 110.10(d)4SupervisionResponsibility for assuring compliance with current good manufacturing practices relating to personnel has not been assigned to competent supervisory personnel. Specifically, ***
365121 CFR 110.37(b)(5)4Cross contaminationSystems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing. Specifically, ***
406221 CFR 113.100(a)4Critical factors - entry missing informationForms used to record critical factors lack [closing machine vacuum in vacuum-packed products] [maximum fill-in weight] [drained weight] [critical factors specified in the scheduled process]. Specifically, ***
418121 CFR 113.894Process deviation identificationFailure to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control. Specifically, ***
442121 CFR 110.20(a)4Maintenance of groundsMaintenance of the grounds is inadequate to protect against contamination of food. Specifically, ***
451121 CFR 108.25(f)4Approved schoolFailure 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, ***
451521 CFR 108.35(c)(2)4Process filingFailure to provide FDA, before packing any new product, information as to the scheduled process for each low-acid canned food in each container. Specifically, ***
1270921 CFR 129.80(c)4Records of cleaning/sanitizing solutionsYou do not maintain records of [sampling] [testing] of cleaning and sanitizing solutions. Specifically, ***
1271821 CFR 120.6(a)4Before, during, after processingYour sanitation standard operating procedure does not address sanitation conditions and practices [before] [during] [after] processing. Specifically, ***
1273121 CFR 120.7(a)(2)4Hazard evaluation not completeThe evaluation of a food hazard identified in your written hazard analysis [did not determine if the hazard were reasonably likely to occur] [did not include an assessment of the severity of the illness or injury if the food hazard occurred]. Specifically, ***
97621 CFR 123.9(b)(2)3Process adequacy recordsThe 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, ***
113221 CFR 110.40(a)3Food-contact - unlawful indirect additivesFailure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives. Specifically, ***
125521 CFR 129.20(a)3Bottling room separationThe bottling room is not [adequately] separated from other plant operations or storage areas, so as to protect against contamination. Specifically, ***
129021 CFR 110.20(a)(4)3Waste disposalFailure 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, ***
153421 CFR 113.100(b)3Entries not doneRequired entries on [processing records] [production records] were not made by the retort or processing system operator or other designated person for specific retort operations or conditions specified in the scheduled process. Specifically, ***
156921 CFR 110.35(d)(2)3Continuous operationsFailure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary. Specifically, ***
160021 CFR 110.37(a)3General inadequacyFailure to use a water supply that is [sufficient for the operations] [derived from an adequate source]. Specifically, ***
166921 CFR 110.80(a)(3)3Aflatoxin and other natural toxinsThere 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, ***
167021 CFR 110.80(a)(4)3Safety assurance - pests/extraneous materialsThere 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, ***
170621 CFR 110.80(b)(10)3Mechanical manufacturing controlFailure to perform mechanical manufacturing steps so as to protect food against contamination. Specifically, ***
181221 CFR 129.80(c)3Testing of cleaning/sanitizing solutionsYou do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance. Specifically, ***
230121 CFR 129.80(f)3Bacteriological contamination of containers and closures (S)You do not take a bacteriological swab and/or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing. Specifically, ***
242721 CFR 110.80(b)(9)3Proper disposal of adulterated productFailure to dispose of adulterated [food] [raw materials] in a manner which protects against the contamination of other food. Specifically, ***
307421 CFR 114.80(a)(2)3Using pH meterFailure to [use a potentiometer to measure pH] [relate in-process measurements by titration or colorimetry to the finished equilibrium pH] when the finished equilibrium pH is above 4.0. Specifically, ***
365021 CFR 110.35(d)(1)3Wet cleaningFailure to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned. Specifically, ***
370921 CFR 110.80(a)(1)3Inspection of containers and carriers upon receiptFailure 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, ***
429521 CFR 110.40(a)3Food contact - non-toxic materialsFood-contact surfaces are not made of non-toxic materials. Specifically, ***
446521 CFR 114.100(c)3Process deviations - action to rectifyFailure to record the action taken to rectify a departure from a scheduled process. Specifically, ***
447521 CFR 108.25(c)(3)(i)3Process adherenceFailure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, ***
447621 CFR 108.25(c)(3)(ii)3Process information availabilityFailure to provide the FDA, after written request, any process and procedure information deemed necessary to determine the adequacy of the process. Specifically, ***
995221 CFR 120.11(a)(1)(i)3Complaint reviewYour review of consumer complaints does not determine whether such complaints [relate to the performance of the HACCP plan] [reveal previously unidentified critical control points]. Specifically, ***
1272121 CFR 1.2343Registration not updatedYou 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, ***
1273321 CFR 120.11(a)(1)(iv)(C)3Calibration, testing - record review timelinessYou did not review [all of] your [calibration] [periodic end-product testing] [in-process testing] records within a reasonable time after the records were made. Specifically, ***
1274821 CFR 120.8(b)(5)3Corrective action planYour 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,***
93921 CFR 123.9(f)2Computerized recordsYour computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures. Specifically, ***
94921 CFR 123.12(c)2Records, EnglishThe records that document the performance and results of the affirmative step you chose are not in English. Specifically, ***
113021 CFR 110.40(a)2Food-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, ***
118821 CFR 110.37(c)2Sewage disposalFailure to dispose of sewage into an adequate sewerage system or by other adequate means. Specifically, ***
148721 CFR 113.87(b)2Visual indicators not usedHeat-sensitive indicators or other means are not used to visually show that a thermal process has been applied to containers in a retort basket, truck, car, or crate used to hold containers in a retort. Specifically, ***
150021 CFR 113.892Evaluation by process authorityFailure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority. Specifically, ***
152921 CFR 113.892Process deviation log/fileProcess deviations were not recorded in a separate file or log that details both the deviations and the actions taken. Specifically, ***
155921 CFR 110.35(c)2Guard/guide dogsThe [guard dog] [guard dogs] [guide dog] [guide dogs] in the plant are likely to result in the contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
159521 CFR 110.37(b)(1)2Sufficient quantities of waterPlumbing is not [of adequate size and design] [adequately installed and maintained] to carry sufficient quantities of water to required locations throughout the plant. Specifically, ***
163921 CFR 113.100(b)2Entries not timelyEntries on [processing records] [production records] were not made at the time the specific retort or processing system condition or operation occurred. Specifically, ***
166521 CFR 110.80(a)(2)2Pasteurization 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, ***
171621 CFR 113.40(a)(11)2Water valves, leakageFailure to supply a suitable water valve used for water cooling to prevent leakage of water into the retort during processing. Specifically, ***
227421 CFR 129.80(g)(1)2BacteriologicalYou do not take and analyze samples of bottled drinking water for bacteriological testing at least once a week [for each type of bottled drinking water produced during a day's production run]. Specifically, ***
288721 CFR 113.40(j)2Conform to requirementsThe system, equipment, and procedures used for thermal processing of foods in hermetically sealed containers [did not conform to the applicable requirements of 21 CFR 113.40] [did not conform to methods and controls specified in the scheduled process] [were not operated and administered in a manner that ensures commercial sterility is achieved]. Specifically, ***
306821 CFR 114.80(a)(1)2pH controlAcidified 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, ***
370821 CFR 110.80(a)(1)2Water quality -- wash, rinse, convey foodWater [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality]. Specifically, ***
417821 CFR 113.832Commercial production variationsFailure to provide for the type, range, and combination of variations encountered in commercial production in establishing the scheduled process. Specifically, ***
451221 CFR 108.25(g)2Record retentionFailure 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, ***
452321 CFR 108.35(f)2Recall proceduresFailure to prepare and maintain in files current procedures for [recalling products which may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically, ***
4529 2Process change reporting to CFSANFor 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, ***
453021 CFR 114.100(c)2Process deviations - product dispositionFailure to record the disposition of product involved in a departure from a scheduled process. Specifically, ***
992121 CFR 120.10(b)2Corrective action - no planYour 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, ***
993721 CFR 120.7(b)2Inside and outside hazardsYour hazard analysis does not include food hazards that can be introduced [within] [outside] the processing plant environment. Specifically, ***
995021 CFR 120.11(a)2HACCP system not verifiedYou do not verify that your HACCP system is being implemented according to design. Specifically, ***
995321 CFR 120.11(a)(1)(iv)(A)2CCP record reviewYour 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, ***
995921 CFR 120.12(d)(1)2Record retentionYou do not retain [all of] the required records at your facility for the required time period. Specifically, ***
996321 CFR 120.24(c)2Single facility - exempt processYou do not process and perform final product packaging in a single facility operating under current good manufacturing practices. Specifically, ***
997221 CFR 120.25(c)2Analytical methodYou do not [always] analyze each juice subsample for the presence of Escherichia coli by the official method or another method that is at least equivalent. Specifically, ***
97721 CFR 123.9(b)(3)1Records stored at another locationYou did not immediately return your records for official review upon demand. Specifically, ***
104521 CFR 113.101SupervisorsSupervisors have not satisfactorily completed training in a school approved by the Commissioner for areas under their responsibility. Specifically, ***
109321 CFR 110.40(g)1Compressed air/gasesFailure 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, ***
119721 CFR 110.10(a)1Lack of instruction/reporting of health conditionsPersonnel with adverse health conditions are not instructed to report to their supervisors. Specifically, ***
125821 CFR 113.60(c)1Coding - visibleHermetically sealed containers do not have an identifying code permanently visible to the naked eye. Specifically ***
127721 CFR 129.20(d)1Enclosed room for container washing and sanitizingYou do not [wash] [sanitize] containers for bottled drinking water in an enclosed room. Specifically, ***
130321 CFR 113.81(f)1Critical FactorsThe critical factors identified in the schedule process for the prevention of the growth of microorganisms not destroyed by the thermal process are not controlled in a manner to ensure the limits established are not exceeded. Specifically, ***
131721 CFR 113.87(d)1Timing devicesFailure to provide accurate timing devices to ensure that the processing and venting times specified in the scheduled process are achieved. Specifically, ***
132021 CFR 113.87(g)1Bleeder mufflersFailure to keep on file evidence that mufflers on [bleeders] [the vent system] are operating in a manner that does not impede the removal of air . Specifically, ***
132521 CFR 113.100(e)1Record retentionCopies of processing, production, and other required records for each lot of a low-acid food processed were not retained at the processing plant [for a one year period following manufacture] [or other reasonably accessible location for a total of a three-year record-retention period]. Specifically, ***
132921 CFR 113.100(a)1Processing entries not done/not timelyRequired information was not entered on designated forms at the time the observation was made by the retort or processing system operator or designated person. Specifically, ***
133121 CFR 113.100(a)(1)1Still retortsForms used in recording specific processing and production information for still retorts lack [the time that steam was turned on] [the time that the retort reached processing temperature] [the time that steam was shut off] [venting time] [venting temperature]. Specifically, ***
133421 CFR 113.100(a)(4)1Aseptic processingForms used in recording specific processing and production information for aseptic processing and packaging systems lack [the product temperature in the holding tube outlet] [the product temperature in the final heater outlet] [differential pressure] [product flow rate] [sterilization media flow rate] [sterilization media temperature] [retention time of containers and closures] [sterilization cycle times] [sterilization cycle temperatures]. Specifically, ***
135321 CFR 129.35(a)(3)(i)1Sampling for micro contaminantsThe [product] [operations] source water that is obtained from other than a public water system is not sampled and analyzed for microbiological contaminants at least once each week. Specifically, ***
138121 CFR 129.35(b)1Free of oil, dust, rust, etc.Air under pressure that is directed at [product water] [a product water-contact surface] is not free of [oil] [dust] [rust] [excessive moisture] [extraneous materials]. Specifically, ***
141221 CFR 129.37(b)1Transport and storageAfter cleaning, you do not [transport] [store] all [multiservice containers] [utensils] [disassembled piping and equipment] in such a manner as to [assure drainage] [be protected from contamination]. Specifically, ***
147221 CFR 113.831Critical factors not statedCritical factors that may affect the scheduled process are not specified in the scheduled process. Specifically, ***
148621 CFR 113.87(b)1System not establishedA system of traffic control to prevent unretorted product from bypassing the retort system has not been established. Specifically, ***
149921 CFR 113.891No corrective action takenNo 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, ***
153321 CFR 113.100(b)1RTC identificationRecording thermometer charts were not identified by [date] [retort number] [data to correlate with written records of lots processed]. Specifically ***
164021 CFR 113.100(b)1Entries not signedThe retort or processing system operator or other designated person did not initial or sign each record form. Specifically, ***
164421 CFR 113.100(c)1Not signed or initialedWritten records of container closure examinations were not signed or initialed by the container closure inspector. Specifically, ***
165321 CFR 113.40(a)(1)1Unreadable MIG thermometerMercury-in-glass thermometers were not installed where they can be accurately and easily read. Specifically, ***
168821 CFR 110.801Supervisory competenceThe 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, ***
170821 CFR 110.80(b)(12)1Batters, 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, ***
171021 CFR 110.80(b)(14)1Water activity controlsFailure to adequately [process to] [maintain at] a safe moisture level foods that rely on the control of water activity to prevent the growth of undesirable microorganisms. Specifically, ***
173521 CFR 113.40(a)(2)1Unauthorized adjustmentThere was no means to prevent unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
185521 CFR 113.40(a)(12)1InstallationVents are not installed so as to provide complete removal of air from a retort before the process start time. Specifically, ***
186321 CFR 113.40(a)(12)1Manifold header to atmosphereA manifold header connecting vents or manifolds from several retorts was not vented to the atmosphere. Specifically, ***
194521 CFR 129.80(d)1Records of sanitizing times and intensities (S)You do not maintain [adequate] records regarding [the intensity of the sanitizing agent] [the time duration that the sanitizing agent was in contact with the surface being sanitized]. Specifically, ***
205621 CFR 123.28(a)1HACCP planYour HACCP plan for raw molluscan shellfish does not include controls to ensure the molluscan shellfish are harvested from an approved source. Specifically, ***
205721 CFR 123.28(c)1Harvest licensureYou do not have controls to ensure that the shellstock you receive [is from a harvester that is in compliance with licensure requirements or from a processor certified by a shellfish control authority] [has a tag affixed to each container or is accompanied by a bill of lading or similar document with specific information]. Specifically, ***
205921 CFR 123.28(d)1Labels - shucked shellfishYou do not have controls in place to ensure that shucked molluscan shellfish are in containers that bear a label that discloses [the date and place they were harvested] [the type and quantity of shellfish] [by whom they were harvested]. Specifically, ***
206721 CFR 123.28(d)1Records - shucked shellfishYou do not maintain records of shucked molluscan shellfish that document the [date of receipt] [quantity and type of shellfish] [name and certification number of the packer or repacker of the product]. Specifically, ***
210121 CFR 113.40(a)(13)1Measured, recordedCritical factors are not [measured] [recorded] on the processing record at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process. Specifically, ***
227121 CFR 129.80(e)1Package identificationYou do not identify each unit package from a [batch] [segment of a continuous production run] of bottled drinking water with a production code which identifies [the particular batch] [the segment of production run] [the day produced]. Specifically, ***
227221 CFR 129.80(e)1Plant recordsYou do 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, ***
232021 CFR 113.40(c)(2)1Corresponding with MIGFailure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***
233221 CFR 113.40(c)(5)1Location - separationRetort bleeders are installed more than eight (8) feet apart. Specifically, ***
234221 CFR 113.40(c)(6)1Heat distributionHeat distribution data or documentary proof from the retort manufacturer or process authority that adequate venting is achieved in the retort was not kept on file. Specifically, ***
234321 CFR 113.40(c)(7)1Rotational speedThe rotational speed of the retort was not [specified in the scheduled process] [adjusted and recorded when the retort is started] [adjusted and recorded when a speed change was made] [adjusted and recorded at intervals of sufficient frequency to ensure the speed was maintained as specified in the scheduled process]. Specifically, ***
236921 CFR 129.80(a)1Equipment / substancesYou treat product water [in and by equipment] [with substances] that may adulterate the bottled product. Specifically, ***
242821 CFR 110.80(b)(9)1Proper reconditioningFailure to use a proven effective method of reconditioning adulterated food. Specifically, ***
250321 CFR 113.40(e)(2)1Unauthorized adjustmentThere was no means of preventing unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
253421 CFR 113.40(f)(2)1Presence and accuracyEach retort did not have an accurate temperature-recording device. Specifically, ***
282021 CFR 113.40(g)(1)(i)(d)1Product-to-product regeneratorsThe product-to-product regenerator was not [designed] [operated] [controlled] to ensure that the pressure of the sterilized product in the regenerator is greater than that of the unsterilized product in the regenerator. Specifically, ***
286021 CFR 113.40(g)(1)(i)(f)1Unauthorized speed changesThere was no means of preventing unauthorized speed changes to the metering pump. Specifically, ***
286921 CFR 113.40(g)(1)(ii)(e)1Readings at start of aseptic processingMeasurements or observations of the [temperature-indicating device in the holding tube outlet] [temperature recorder in the holding tube outlet] [temperature recorder-controller at the final heater outlet] [differential pressure recorder-controller] [product flow rate] [sterile air pressure] [proper performance of seam seals or similar devices] were not [performed] [recorded] at the start of aseptic processing to ensure the values were as specified in the scheduled process for aseptic packaging operations. Specifically, ***
288621 CFR 113.40(i)1Inadequate instrumentsThe time and temperature of processing and other critical factors specified in the scheduled process were not measured with instruments having adequate accuracy or dependability. Specifically, ***
307221 CFR 114.80(a)(1)1Thermal processingAcidified 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, ***
309121 CFR 114.100(e)1RetentionRequired 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, ***
364421 CFR 110.10(b)(5)1Impermeable (S)Gloves used for food handling are not impermeable. Specifically, ***
364821 CFR 110.20(a)(4)1Neighboring groundsFailure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control. Specifically, ***
382221 CFR 113.40(a)(1)1Records of calibration (S)Failure to maintain records of accuracy checks of temperature-indicating devices specifying [date] [standard used] [method used] [person performing the test]. Specifically, ***
383321 CFR 113.40(g)(1)(i)(i)1Barriers to product contamination (S)Failure to supply steam seals or other effective barriers at potential access points to the product downstream from the product-sterilizing holding tube. Specifically, ***
385621 CFR 113.60(a)1VisualFailure of the operator, closure supervisor, or other qualified person to visually examine [the top seam of a can randomly selected from each seaming head] [the closure of a typical container]. Specifically ***
386621 CFR 113.60(a)(1)(i)(a)1Required can seam measurements (micrometer)Records of the results of micrometer measurements of double seam cans fail to include [cover hook] [body hook] [width] [tightness] [thickness]. Specifically, ***
387421 CFR 113.60(b)1Cooling water - failure to chlorinate, etc.Failure to chlorinate or otherwise sanitize container cooling water as necessary for cooling canals and recirculated water supplies. Specifically, ***
387621 CFR 113.60(c)1Coding - failure to markFailure to mark each hermetically sealed container of low-acid processed food with an identifying code that is permanently visible to the naked eye. Specifically, ***
387721 CFR 113.60(c)1Coding - required elementsThe required container identification fails to include the [establishment where packed] [product] [year packed] [day packed] [period during which packed]. Specifically, ***
388621 CFR 113.87(e)1Clock time agreement with time of day (S)Failure of the clock times indicated on recording-temperature charts to reasonably correspond to the time of day on the written processing records. Specifically, ***
388721 CFR 113.891Methods of process deviation evaluationFailure 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, ***
406721 CFR 113.40(a)(12)(iii)1Venting, other installationsFailure to have heat distribution data on file which demonstrates that adequate venting of air is accomplished, for retort installations which deviate from the diagrams in [113.40(a)(12)(i)(a)] [113.40(a)(12)(i)(b)] [113.40(a)(12)(i)(c)] [113.40(a)(12)(i)(d)] [113.40(a)(12)(ii)(a)] [113.40(a)(12)(ii)(b)]. Specifically, ***
446021 CFR 114.80(a)(1)1Use of preservatives (S)Failure to use preservatives (in lieu of thermal processing) to inhibit reproduction of microorganisms of non-health significance. Specifically, ***
451921 CFR 108.35(c)(3)(i)1Process adherenceFailure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, ***
452021 CFR 108.35(c)(3)(ii)1Process information availabilityFailure to provide FDA, when requested in writing, with information concerning processes and procedures deemed necessary to determine the adequacy of the process. Specifically, ***
452121 CFR 108.35(d)1Notify FDA - spoilageFailure to notify FDA about [spoilage] [process deviations] of potential public health significance when all or part of a lot was distributed. Specifically, ***
452421 CFR 108.35(g)1Approved schoolFailure 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, ***
600321 CFR 123.28(b)1Harvest controlsYou do not ensure that raw molluscan shellfish being processed are obtained from growing waters approved for harvesting by a shellfish control authority. Specifically***
601121 CFR 123.8(a)(3)(ii)1Corrective action record review adequacyYour review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions have been taken]. Specifically, ***
981221 CFR 106.100(k)(4)1Complaint filesFailure to maintain complaint files [in two separate classes, e.g., complaints that allege that an infant became ill from consuming the product, or that an infant required treatment by a physician or health-care provider; and complaints that may involve a possible existence of a hazard to health, but do not indicate that an infant became ill or required treatment]. Specifically, ***
991421 CFR 120.14(c)1Records, EnglishYou do not have records [in English] that document the performance and results of the affirmative steps you chose. Specifically, ***
992321 CFR 120.10(b)(2)1Review - trained individualYour review to determine the acceptability of affected product for distribution when a deviation from a critical limit occurred was not performed by [an individual] [individuals] with adequate training or experience . Specifically, ***
993321 CFR 120.6(b)1Timely correctionYou do not [always] correct deficiencies from good manufacturing practice in a timely manner. Specifically, ***
993821 CFR 120.7(d)1Sanitation evaluation not complete (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, ***
994921 CFR 120.11(b)1HACCP plan not modifiedYou did not immediately modify your HACCP plan after a validation revealed that the plan was no longer adequate. Specifically, ***
997521 CFR 120.25(d)1RecordingYou did not [always] record positive results for Escherichia coli analysis. Specifically, ***
998621 CFR 120.24(c)1Single facility - not exempt under 120.24(a)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, ***
1273621 CFR 120.12(e)1Official reviewYou did not make all required records available for review and copying at reasonable times. Specifically, ***
1273721 CFR 120.14(a)(2)(i)1Product specsYour product specifications are not designed to ensure that imported juice [is safe] [has been processed under sanitary conditions]. Specifically, ***
1275321 CFR 120.11(a)(1)(iv)(A)1CA record reviewYour review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions were taken]. Specifically, ***

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Devices

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Devices418921 CFR 820.198(a)153GeneralComplaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented]. Specifically, ***
313021 CFR 820.100(a)135Procedures - generalProcedures for corrective and preventive action have not been [adequately] established. Specifically, ***
369621 CFR 820.100(b)100Lack of documentation of CAPA activitiesCorrective and preventive action activities and/or results have not been [adequately] documented. Specifically, ***
63021 CFR 803.17100Lack of Written MDR ProceduresWritten MDR procedures have not been [developed] [maintained] [implemented]. Specifically, ***
54621 CFR 820.75(a)97GeneralA process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. Specifically, ***
405821 CFR 820.2092Management responsibilityManagement with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization. Specifically, ***
232721 CFR 820.2285Quality audit proceduresProcedures for quality audits have not been [adequately] established. Specifically, ***
237121 CFR 820.30(a)80Design control proceduresProcedures for design control have not been established. Specifically,***
366621 CFR 820.20(c)75Management review proceduresProcedures for management review have not been [adequately] established. Specifically,***
341521 CFR 820.2270Quality audits conductedQuality [audits][reaudits] have not been performed. Specifically, ***
44721 CFR 820.4064Document control proceduresDocument control procedures have not been [established] [maintained]. Specifically,***
329121 CFR 820.100(b)63ProceduresThe procedures addressing documentation of corrective and preventive action activities were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
317221 CFR 820.198(c)63Investigation of device failuresComplaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, ***
383721 CFR 820.25(b)61Training documentationPersonnel training is not documented. Specifically, ***
323321 CFR 820.72(a)51Calibration, inspection, equipment control proceduresProcedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established. Specifically, ***
310321 CFR 820.30(i)51Design changes - procedures prior to implementationProcedures for design change have not been [adequately] established. Specifically,***
312521 CFR 820.80(d)49Procedures, finished devicesProcedures for finished device acceptance have not been [adequately] established. Specifically, ***
311821 CFR 820.75(a)47Documentation - generalProcess validation [activities] [results] have not been [documented] [approved] [adequately documented] [adequately approved]. Specifically, ***
53821 CFR 820.70(a)47Process control proceduresProcess control procedures that describe any process controls necessary to ensure conformance to specifications were not [established] [defined] [documented] [implemented]. Specifically, ***
368721 CFR 820.100(a)(1)46Analysis of data sourcesAppropriate sources of quality data are not adequately analyzed to identify existing and potential causes of nonconforming product and other quality problems. Specifically, ***
337121 CFR 820.198(a)(3)45Processing MDRs {see also 803, 804}Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report. Specifically, ***
47921 CFR 820.5043Purchasing control proceduresProcedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established. Specifically, ***
328221 CFR 820.90(a)42Nonconforming product control proceduresProcedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, ***
369021 CFR 820.100(a)(3)40Identification of actions neededNot all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified. Specifically, ***
315521 CFR 820.181(a)40DMR device specificationsThe device master record does not include or refer to the location of device software specifications. Specifically, ***
316021 CFR 820.18439Establishing device history record proceduresProcedures for device history records have not been [adequately] established. Specifically,***
230221 CFR 820.20(e)38Quality System ProceduresQuality system procedures and instructions have not been established. Specifically,***
48621 CFR 820.50(a)38Evaluation of suppliers, contractors and consultantsRequirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established. Specifically, ***
297421 CFR 812.110(b)37Investigator non-compliance with agreement/plan/regulationsAn 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, ***
296821 CFR 812.10037Investigator non-compliance with agreement/plan/regulationsAn investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations]. Specifically, ***
73221 CFR 803.50(a)(2)37Report of MalfunctionAn 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, ***
366921 CFR 820.20(c)36Management reviews at defined intervalsManagement with executive responsibility has not reviewed the suitability and effectiveness of the quality system [at defined intervals] [with sufficient frequency]. Specifically, ***
329921 CFR 820.100(a)(1)35Procedure for analysis of data sourcesThe corrective and preventive procedures addressing the analysis of sources of quality data to identify existing and potential causes of nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
316721 CFR 820.198(a)33Complete files maintainedComplete complaint files are not maintained. Specifically, ***
369221 CFR 820.100(a)(4)32CAPA verification/validation of corrective/preventive actionCorrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device. Specifically, ***
367821 CFR 820.30(g)31Risk analysisRisk analysis [was not performed] [is inadequate] [is incomplete]. Specifically, ***
336921 CFR 820.198(a)(1)30Uniform and timely processingComplaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints are processed in a uniform and timely manner. Specifically, ***
312021 CFR 820.80(a)30GeneralProcedures for acceptance activities have not been [adequately] established. Specifically,***
54121 CFR 820.70(c)30Environmental controlProcedures to control environmental conditions have not been [adequately] established. Specifically, ***
366521 CFR 820.20(b)(3)29Management representativeNo management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system. Specifically, ***
312121 CFR 820.80(b)29Receiving acceptance proceduresProcedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
235121 CFR 820.25(b)29TrainingEmployees have not been adequately trained. Specifically, ***
235021 CFR 820.25(b)29Training - Lack of or inadequate proceduresProcedures for training and identifying training needs have not been [adequately] established. Specifically, ***
73121 CFR 803.50(a)(1)29Report of Death or Serious InjuryAn 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, ***
1450521 CFR 812.140(a)(3)28Investigator's subject records inadequateRecords of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current]. Specifically, ***
405921 CFR 820.2228Quality audits - effectiveness of quality systemQuality 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, ***
312721 CFR 820.80(e)27DocumentationAcceptance activities were not [documented] [maintained as part of the device history record] [adequately documented] [adequately maintained as part of the device history record]. Specifically, ***
328821 CFR 820.90(b)(1)26Documentation of disposition, justification, signatureThere is [no] [incomplete] documentation of the [disposition of nonconforming product] [justification for use of nonconforming product] [the signature of the individual authorizing the use of nonconforming product]. Specifically, ***
316421 CFR 820.184(d)26Acceptance recordsThe device history record does not include [complete] acceptance records that demonstrate the device is manufactured in accordance with the device master record. Specifically, ***
328321 CFR 820.90(a)25Specific non-conforming product proceduresProcedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition] [investigation] of nonconforming product were not [defined] [documented] [complete]. Specifically, ***
311721 CFR 820.70(i)24Software validation for automated processesSoftware used as part of [production] [the quality system] has not been [adequately] validated for its intended use according to an established protocol. Specifically, ***
343321 CFR 820.75(c)23Process changes - review, evaluation and revalidationA validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, ***
328421 CFR 820.90(a)23Nonconforming product evaluation/investigationThe [evaluation] [investigation] of nonconforming product has not been documented. Specifically, ***
320121 CFR 820.40(a)23Not approved or obsolete document retrievalDocuments that were [not approved] [obsolete] were observed at a location where they [could be] [are being] used. Specifically, ***
319921 CFR 820.40(a)23Document review, approval documentationThe documentation of approval of documents does not include [the document approval date] [the signature of the approving official]. Specifically, ***
229321 CFR 820.20(d)23Quality planA quality plan has not been [adequately] established. Specifically, ***
368821 CFR 820.100(a)(1)22Analysis of data/reports from data sourcesNot all [data] [reports] from quality data sources are analyzed to identify existing and potential causes of nonconforming product and other quality problems. Specifically, ***
330121 CFR 820.100(a)(2)22Investigation proceduresThe corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to product, processes, and the quality system were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
341621 CFR 820.70(a)(1)21Process control instructionsProcess controls are not conducted in accordance with documented instructions and standard operating procedures. Specifically, ***
333221 CFR 820.184(e)21ID label, labelingThe device history record does not include the primary identification label and labeling for each device. Specifically, ***
315921 CFR 820.18421DHR content - generalThe device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820].
310421 CFR 820.30(j)21Design history fileThe 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].
53721 CFR 820.70(a)21Production processesProduction processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications. Specifically, ***
310121 CFR 820.30(g)20Design validation proceduresProcedures for design validation have not been [adequately] established. Specifically,***
232821 CFR 820.2220Quality audits, auditor independenceIndividuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***
419121 CFR 806.10(a)(1)19Report of risk to healthA correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Specifically, ***
368921 CFR 820.100(a)(2)19InvestigationCertain indicators of nonconformities are not investigated to determine the cause of the nonconformity. Specifically, ***
338021 CFR 820.198(e)(6)19Results of investigationRecords of complaint investigations do not include the [dates] [results] of the investigation. Specifically, ***
325021 CFR 820.72(b)(2)19Calibration documentationThere is [no] [incomplete] documentation of [the equipment identification] [calibration dates] [the individual performing each calibration] [the next calibration date] for [inspection] [measurement] [test] equipment . Specifically, ***
311921 CFR 820.75(b)19Monitoring and control of validated processesProcedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifically, ***
326821 CFR 820.80(b)18Incoming inspection, testing, verificationIncoming product was not adequately inspected or tested to verify conformance to specifications. Specifically, ***
312821 CFR 820.90(a)18Nonconforming product controlProducts that do not conform to specifications are not adequately controlled. Specifically, ***
262821 CFR 820.30(e)18Design review procedures - personnelProcedures were not [established] [defined] [documented] [complete] [implemented] for ensuring that participants at each design review include [representatives of all functions concerned with the design stage being reviewed] [an individual who does not have direct responsibility for the design stage being reviewed] [any specialists needed]. Specifically, ***
226921 CFR 820.20(a)18Quality policy establishedThe [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility. Specifically, ***
407021 CFR 820.30(g)17Design validation documentation, DHF {see also 820.30(j)}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, ***
367721 CFR 820.30(g)17Design validation of device softwareValidation of device software [was not performed] [is inadequate] [is incomplete]. Specifically, ***
330421 CFR 820.100(a)(5)17Changes to correct/prevent quality problemsChanges in methods and procedures needed to correct and prevent identified quality problems are not [implemented] [recorded] [effective]. Specifically, ***
310221 CFR 820.30(h)17Design transferProcedures for design transfer have not been [adequately] established. Specifically,***
322621 CFR 820.70(g)(1)16ScheduleSchedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established. Specifically, ***
298121 CFR 812.140(a)(2)(i)16Investigator device accountability inadequateRecords 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, ***
265021 CFR 820.30(f)16Design verificationProcedures for design verification have not been [adequately] established. Specifically,***
264821 CFR 820.30(f)16Design verification proceduresProcedures for verifying that design output meets design input were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
242921 CFR 820.30(b)16Establish the design and development planA design and development plan has not been [established] [defined] [documented] [implemented]. Specifically, ***
330321 CFR 820.100(a)(4)15Verify, validate change {see also 820.100(a)}The procedures addressing verification or validation of corrective and preventive actions were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
328521 CFR 820.90(b)(2)15Product rework proceduresProcedures for rework of nonconforming product have not been [adequately] established. Specifically, ***
315721 CFR 820.181(c)15DMR QA procedures and specificationsThe device master record does not include or refer to the location of [all] quality assurance procedures and specifications. Specifically, ***
313221 CFR 820.12015Labeling procedures - generalProcedures to control labeling activities have not been [adequately] established. Specifically, ***
368021 CFR 820.70(a)14Process control procedure contentProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been [adequately] established. Specifically, ***
342721 CFR 820.50(a)(2)14Supplier oversightThe type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, ***
334521 CFR 820.200(a)14Procedures establishedProcedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been [adequately] established. Specifically, ***
328621 CFR 820.90(b)(1)14Procedures for product review, dispositionProcedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been [adequately] established. Specifically, ***
315621 CFR 820.181(b)14DMR production process specificationsThe device master record does not include or refer to the location of [all] production and process specifications. Specifically, ***
298421 CFR 812.140(a)(3)(i)14Investigator records of informed consent inadequateRecords documenting that informed consent was obtained for each subject prior to participation in the study are not all [accurate] [complete] [current]. Specifically, ***
421221 CFR 806.20(b)(4)13Justification for not reportingA 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,***
330221 CFR 820.100(a)(3)13Identifying corrective & preventive actionsThe procedures addressing identification of corrective and preventive actions were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
323121 CFR 820.70(i)13Documentation of software validationSoftware 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, ***
312321 CFR 820.80(c)13ProceduresProcedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***
53921 CFR 820.70(b)13Production and process change proceduresProcedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established. Specifically, ***
368121 CFR 820.70(b)12Verification or validation of changesChanges to a [specification] [method] [process] [procedure] were not verified or validated. Specifically, ***
341721 CFR 820.70(a)(2)12Production monitoring and controlDuring production, [process parameters] [component and device characteristics] are not [fully] monitored and controlled. Specifically, ***
327621 CFR 820.80(e)12Maintained as part of the DHR {see also 820.184}Acceptance records were not maintained as part of the device history record. Specifically, ***
327021 CFR 820.80(c)12DocumentationIn-process inspections, tests, or other verification activities and approvals were not documented. Specifically, ***
315121 CFR 820.18012LegibilityRequired records are not legible. Specifically, ***
302121 CFR 812.150(a)(1)12Investigator report of unanticipated adverse effectsA complete and accurate report of an unanticipated adverse device effect was not prepared and submitted [within 10 working days after first learning of the effect] to [the sponsor] [the reviewing IRB]. Specifically, ***
260421 CFR 820.30(e)12Design review procedures - generalProcedures for design review have not been [adequately] established. Specifically,***
54021 CFR 820.70(b)12Production and process changes - failure to follow procedureEstablished procedures were not followed [completely] in making changes to [specifications] [methods] [processes] [procedures]. Specifically, ***
368621 CFR 820.90(b)(2)11Product rework documentation, DHR {see also 820.184}Rework and reevaluation activities have not been [fully] documented in the device history record. Specifically, ***
368321 CFR 820.70(g)11Installation, placement qualificationThe [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, ***
342621 CFR 820.50(a)(1)11Documenting evaluationThe evaluation of potential [suppliers] [contractors] [consultants] was not documented. Specifically, ***
326921 CFR 820.80(b)11Incoming acceptance records, documentationAcceptance or rejection of incoming product was not documented. Specifically, ***
317021 CFR 820.198(b)11Review and evaluation for investigationNot all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
310821 CFR 820.70(e)11Contamination control proceduresProcedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been [adequately] established. Specifically, ***
255721 CFR 820.30(c)11Design input documentationDesign input requirements were not [adequately] documented. Specifically, ***
370221 CFR 820.250(a)10AppropriatenessThere is no information to support the appropriateness of the statistical techniques used. Specifically, ***
367621 CFR 820.30(f)10Design verification documentation, DHF {see also 820.30(j)}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, ***
342821 CFR 820.50(a)(3)10Acceptable supplier recordsRecords of acceptable [suppliers] [contractors] [consultants] were not maintained. Specifically, ***
326221 CFR 820.250(a)10Establish procedures for identifying statistical techniquesProcedures 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,***
320721 CFR 820.50(b)10Supplier notification of changesThere is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service. Specifically, ***
320621 CFR 820.50(b)10Purchasing records, specificationPurchasing 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, ***
320421 CFR 820.40(b)10Change records, contentRecords 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, ***
319221 CFR 820.30(g)10Design validation per user needs and intended useDesign validation did not ensure the device conforms to defined user needs and intended uses. Specifically, ***
314121 CFR 820.150(a)10Storage procedures to prevent mix-upsProcedures for controlling the storage of product in storage areas and stock rooms were not [established] [defined] [documented] [complete] [implemented] to prevent mix-ups, damage, other adverse effects. Specifically, ***
298521 CFR 812.140(a)(3)(ii)10Investigator records of relevant observations inadequateRecords 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, ***
297021 CFR 812.10010Investigator lack of informed consentInformed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, ***
260121 CFR 820.30(d)10Essential design outputsDesign outputs that are essential for the proper functioning of the device were not [completely] identified. Specifically, ***
366421 CFR 820.20(b)(2)9TrainingPersonnel are not adequately trained to perform [management activities] [work] [assessment activities] [audits]. Specifically, ***
339821 CFR 820.80(d)(3)9No release signatureFinished devices were released for distribution without signature of the individual designated to authorize such release. Specifically, ***
337921 CFR 820.198(e)(5)9Nature and details of complaintRecords of complaint investigations do not include the nature and details of the complaint. Specifically, ***
326321 CFR 820.250(b)9Establishment, appropriatenessSampling plans are not [written][based on valid statistical rationale]. Specifically, ***
323221 CFR 820.72(a)9Equipment suitability & capabilityCertain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results]. Specifically, ***
317321 CFR 820.198(d)9Evaluation, timeliness, identificationComplaints 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, ***
317121 CFR 820.198(b)9Rationale documented for no investigationRecords for complaints where no investigation was made do not include required information. Specifically ***
314421 CFR 820.160(a)9Control/distribution proceduresProcedures for the control and distribution of finished devices have not been [established] [defined] [documented] [complete] [implemented] to ensure that only devices approved for release are distributed. Specifically, ***
302521 CFR 812.150(a)(3)9No investigator progress reportsProgress reports on the investigation were not submitted [at the required intervals] [at least yearly] to the [sponsor] [monitor] [reviewing IRB]. Specifically, ***
298021 CFR 812.140(a)(1)9Investigator correspondence records inadequateRecords relating to correspondence with [another investigator] [an IRB] [the sponsor] [a monitor] [FDA], including required reports, are not all [accurate] [complete] [current]. Specifically, ***
263021 CFR 820.30(e)9Design review documentation, DHF {see also 820.30(j)}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, ***
259921 CFR 820.30(d)9Acceptance criteria and essential outputsDesign output procedures do not [contain or reference acceptance criteria] [ensure that essential design outputs are identified] [allow for an adequate evaluation of conformance to design input requirements]. Specifically, ***
247021 CFR 820.30(c)9Design input procedures - appropriatenessProcedures to ensure that a device's design input requirements are appropriate and address its intended use, including user/patient needs, were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
63121 CFR 803.17(a)(1)9Lack of System for Event EvaluationsThe 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, ***
50221 CFR 820.609IdentificationProcedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately] established. Specifically, ***
45421 CFR 820.40(a)9Document review, approval by designated individualDocuments were [not reviewed] [not approved] by designated individual(s) prior to issuance . Specifically, ***
1450821 CFR 812.140(a)(4)8Investigator record of protocol deviations inadequateRecords showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete] [current]. Specifically,***
420821 CFR 806.20(a)8Records not keptThere is no record maintained of a correction or removal action that was not required to be reported to FDA. Specifically,***
419321 CFR 806.10(b)8Time to report - 10 daysA 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, ***
367021 CFR 820.20(c)8Management review participantsDocumentation does not show that management with executive responsibility participated in management reviews. Specifically, ***
339721 CFR 820.80(d)(2)8Review of data and documentationFinished devices were released for distribution before the associated data and documentation was reviewed. Specifically, ***
338121 CFR 820.198(e)(7)8Corrective action takenRecords of complaint investigations do not include any corrective action taken. Specifically, ***
326621 CFR 820.868Clearly identifiedThe acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained]. Specifically, ***
322721 CFR 820.70(g)(1)8Activity documentationMaintenance activities, including the [date] [individuals performing those activities], have not been documented. Specifically, ***
319121 CFR 820.30(g)8Design validation production unitsThe design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents]. Specifically, ***
292821 CFR 812.408Sponsors' general responsibilitiesFor 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, ***
264921 CFR 820.30(f)8Design verification acceptance criteriaAcceptance criteria were not [established] [defined] [documented] [complete] [implemented] prior to the performance of verification activities. Specifically, ***
419221 CFR 806.10(a)(2)7Report 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, ***
369321 CFR 820.100(a)(5)7Implementing changesCorrective and preventive action procedures addressing implementation and recording of changes in methods and procedures to correct and prevent identified quality problems were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
337021 CFR 820.198(a)(2)7Oral complaintsComplaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all oral complaints are documented upon receipt. Specifically, ***
330621 CFR 820.100(a)(7)7Management reviewThe procedures addressing submission of information on identified quality problems and corrective and preventive actions for management review were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
330021 CFR 820.100(a)(1)7Statistical methodologyCorrective and preventive action procedures addressing the use of appropriate statistical methodology to identify existing and potential causes of nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
319021 CFR 820.30(g)7Design validation acceptance criteriaAcceptance criteria were not established prior to the performance of validation activities. Specifically, ***
314921 CFR 820.1807AvailabilityRequired 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, ***
255621 CFR 820.30(c)7Incomplete, ambiguous, conflicting design requirementsDesign input requirements that are [incomplete] [ambiguous] [conflicting] were not addressed. Specifically, ***
243021 CFR 820.30(b)7Adequacy of design and development planDesign plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established. Specifically, ***
684721 CFR 807.30(b)6Listing not updated or update not timelyDevice listing information was not updated [in a timely manner]. Specifically, ***
416921 CFR 820.100(a)(7)6Identifying relevant info for management reviewProcedures addressing identification of relevant information to be submitted for management review were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
416821 CFR 820.100(a)(7)6Management review of CAPAInformation on identified quality problems and corrective actions has not been [submitted for review by] [reviewed by] management. Specifically, ***
406021 CFR 820.20(b)(3)(i)6Management representative implementing the quality systemThe management representative has not ensured that the quality system requirements are effectively established and maintained. Specifically, ***
367521 CFR 820.30(f)6Design verification - unresolved discrepanciesUnresolved discrepancies were noted at the completion of the design verification. Specifically, ***
366721 CFR 820.20(c)6Management review accomplishmentManagement reviews do not ensure that the quality system satisfies [the requirements of part 820] [your quality policy and objectives]. Specifically, ***
339621 CFR 820.80(d)(1)6DMR required activities {see also 820.181}Finished devices were released for distribution prior to completion of activities required in the Device Master Record. Specifically, ***
338221 CFR 820.198(e)(8)6Reply to complainantRecords of complaint investigations do not include any reply to the complainant. Specifically, ***
333021 CFR 820.181(d)6DMR packaging and labeling specificationsThe device master record does not include or refer to the location of [packaging] [labeling] procedures and specifications. Specifically, ***
331621 CFR 820.160(a)6Expired or deteriorated devicesProcedures have not been [established] [defined] [documented] [complete] [implemented] to ensure that expired or deteriorated devices are not distributed. Specifically, ***
323521 CFR 820.72(a)6Equipment control activity documentationEquipment [calibrations] [inspections] [checks][maintenance activities] have not been documented. Specifically, ***
320321 CFR 820.40(b)6Change records maintainedRecords of changes to documents were not [adequately] maintained. Specifically, ***
319521 CFR 820.30(g)6Design validation unresolved discrepanciesUnresolved discrepancies were noted at the completion of the design validation. Specifically, ***
313921 CFR 820.1406Handling procedures to prevent mix-upsProcedures for product handling have not been [adequately] established. Specifically,***
311121 CFR 820.70(f)6BuildingsBuildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations] [prevent mix-ups] [assure orderly handling of product]. Specifically, ***
259821 CFR 820.30(d)6Design output proceduresProcedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
233921 CFR 820.226Quality audit documentationThe dates of quality [audits][reaudits] have not been documented. Specifically, ***
73321 CFR 803.50(b)(1)6Reporting Information Reasonably KnownAn MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer. Specifically, ***
1450721 CFR 812.140(a)(3)(ii)5Investigator adverse effect records inadequateRecords for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current]. Specifically, ***
680021 CFR 807.205Establishment not registeredAn establishment for which registration is required has not been registered. Specifically, ***
369421 CFR 820.100(a)(6)5Dissemination of problem informationInformation related to quality problems or nonconforming product is not disseminated to those directly responsible for assuring the [quality of the product] [prevention of the quality problem]. Specifically, ***
367321 CFR 820.30(c)5Design input approval documentationThe approval of design input requirements [(including the date and signature of the individual approving the requirements)] was not documented. Specifically, ***
366821 CFR 820.20(c)5Management review datesThe results and/or dates of management reviews are not documented. Specifically, ***
343421 CFR 820.75(c)5Documentation - review in response to changes or deviationsThere is no documentation of the [review and evaluation of a process] [revalidation of a process] performed in response to changes or process deviations. Specifically, ***
342521 CFR 820.50(a)(1)5Evaluation and selectionPotential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements. Specifically, ***
331321 CFR 820.120(d)5Records, 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, ***
331221 CFR 820.120(d)5Mix-upsLabeling and packaging operations were not controlled to prevent labeling mix-ups. Specifically, ***
319321 CFR 820.30(g)5Design validation - production units in use conditionsThe design was not validated under actual or simulated use conditions. Specifically, ***
316121 CFR 820.184(a)5DHR content - manufacturing datesThe device history record does not include manufacturing dates. Specifically, ***
304921 CFR 812.150(b)(5)5Sponsor progress reports for significant risk studyProgress reports for a significant risk device study were not submitted [at required intervals] [at least yearly] to [FDA] [all reviewing IRBs]. Specifically, ***
297321 CFR 812.110(a)5Subject participation prior to study approvalSubjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, ***
262721 CFR 820.30(e)5Design reviews performed following scheduleDesign reviews were not performed at appropriate times, following the review schedule. Specifically, ***
54221 CFR 820.70(c)5Environmental control system periodic inspectionsEnvironmental control systems have not been inspected periodically to verify that the system, including necessary equipment, is adequate and functioning properly. Specifically, ***
41921 CFR 820.20(b)5Establish organizational structureThe organizational structure has not been [adequately] established and maintained to ensure that devices are [designed] [produced] in accordance with 21 CFR 820. Specifically, ***
680321 CFR 807.20(a)4Devices not listedDevices for which listing is required have not been listed. Specifically, ***
407121 CFR 820.30(i)4Design changes - validation vs. verificationProcedures were not [established] [defined] [documented] [completed] to address when verification of design changes is sufficient in lieu of validation prior to their implementation. Specifically, ***
405721 CFR 820.20(a)4Management responsibilityManagement with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization. Specifically, ***
383821 CFR 820.40(a)4Document review procedures, designated individualThe document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance. Specifically, ***
368221 CFR 820.70(d)4Implementing Personnel Procedures, Health, Cleanliness.Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented. Specifically, ***
367121 CFR 820.25(a)4Personnel education, background, training & experiencePersonnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***
339921 CFR 820.80(d)(4)4No release authorization dateFinished devices were released for distribution without the authorization being dated. Specifically, ***
334921 CFR 820.200(d)4No documentationService reports were not documented. Specifically, ***
332821 CFR 820.180(b)4Retention periodRequired 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, ***
332521 CFR 820.1804StorageRequired records [are not stored so as to minimize deterioration and prevent loss] [that are stored in automated data processing systems are not backed up]. Specifically, ***
300721 CFR 812.140(d)4Record retention inadequateRequired 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, ***
296921 CFR 812.1004No investigator protection - subject rights, safety, welfareThe rights, safety, and welfare of subjects in an investigational study were not [adequately] protected. Specifically, ***
243121 CFR 820.30(b)4Design plans updatedDesign plans were not [reviewed] [updated] [approved] as design and development evolves. Specifically, ***
233021 CFR 820.224Quality audit corrective action, reaudits {see also 820.100}Quality reaudits [are not adequately performed] [do not cover corrective actions for the problem areas]. Specifically, ***
81221 CFR 803.564Submission Within One MonthA 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, ***
63221 CFR 803.17(a)(2)4Lack of System for Determining MDR EventsThe 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, ***
1451621 CFR 812.25(e)3Sponsor's lack of written monitoring proceduresThere are no written procedures for monitoring an investigational device study. Specifically,***
701221 CFR 812.1003Investigator lack of control of investigational devicesDevices under investigation were not properly controlled. Specifically, ***
700621 CFR 812.43(c)(5)3No financial disclosure info in investigator agreementA 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, ***
384121 CFR 820.90(b)(2)3Product 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, ***
343221 CFR 820.75(b)(2)3Documentation of validated process performanceThere 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, ***
341421 CFR 820.200(d)(6)3Test and inspection dataService reports do not include applicable test and/or inspection data. Specifically, ***
337621 CFR 820.198(e)(2)3Date complaint receivedRecords of complaint investigations do not include the date the complaint was received. Specifically, ***
334721 CFR 820.200(c)3Complaints, MDR reports {see also 820.198(a)(3)}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, ***
331021 CFR 820.120(b)3DHR 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, ***
329021 CFR 820.90(b)(2)3Retesting and reevaluation of reworked productRework of nonconforming product did not include [complete] retesting and reevaluation to ensure that the reworked product met current approved specifications. Specifically, ***
321821 CFR 820.70(c)3Environmental control system-documentation/review inspectionInspections of environmental control system were not [documented] [reviewed]. Specifically, ***
320021 CFR 820.40(a)3Document locations, disseminationDocuments were not available at all locations for which they are designated, used, or otherwise necessary. Specifically, ***
316821 CFR 820.198(a)3Designated unitComplaint files are not [adequately] maintained. Specifically ***
316321 CFR 820.184(c)3Quantity releasedThe device history record does not include the quantity of devices released for distribution. Specifically, ***
316221 CFR 820.184(b)3Quantity manufacturedThe device history record does not include the quantity of devices manufactured. Specifically, ***
302821 CFR 812.150(a)(4)3No approval for investigator change in non-emergencyPrior approval was not obtained from the sponsor for [changes in] [deviations from] an investigational plan in a non-emergency situation. Specifically, ***
299221 CFR 812.140(b)(2)3Sponsor device shipment records inadequateRecords 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, ***
293021 CFR 812.423Sponsor began study before IRB/FDA approval[An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval]. Specifically, ***
260221 CFR 820.30(d)3Design output approvalDesign output was not [reviewed] [approved] before release. Specifically, ***
248121 CFR 820.30(c)3Design input procedures - addressing conflicting requirementProcedures for addressing incomplete, ambiguous, or conflicting design input requirements were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
240321 CFR 820.25(a)3Sufficient personnelInsufficient personnel to assure that all procedures are appropriately carried out as required by the quality system. Specifically, ***
233821 CFR 820.223Quality audit/reaudit reportsReports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited. Specifically, ***
227621 CFR 820.20(b)(1)3Responsibility, authority and independenceEmployees who manage, perform, and assess work affecting quality have not been [assigned the appropriate responsibility and authority] [provided the independence and authority] to accomplish their work. Specifically, ****
63521 CFR 803.17(b)(1)3Info evaluated to determine if event was reportableThe written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable. Specifically, ***
63321 CFR 803.17(a)(3)3Lack of System for Timely Submission of ReportsThe written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to [FDA] [manufacturers]. Specifically, ***
1450921 CFR 812.150(b)(1)2Sponsor evaluation report incomplete, inaccurateReports of the results of evaluation of unanticipated adverse device effects were not all [complete] [accurate]. Specifically, ***
701321 CFR 812.110(d)2Inadequate financial disclosure by investigatorThe 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, ***
421321 CFR 806.20(b)(5)2Records of communicationsA copy of all communications regarding the correction or removal action was not contained in the record. Specifically,***
370121 CFR 820.250(a)2Techniques not usedStatistical techniques are not used for control purposes where statistical techniques are applicable. Specifically, ***
367421 CFR 820.30(d)2Design output documentationDesign output was not [adequately] documented before release. Specifically, ***
342021 CFR 820.70(a)(5)2Criteria for workmanshipCriteria for workmanship have not been expressed in documented standards or by means of identified and approved representative samples. Specifically, ***
340021 CFR 820.80(e)(1)2Activities performedAcceptance records did not include the acceptance activities performed. Specifically, ***
337821 CFR 820.198(e)(4)2Complainant dataRecords of complaint investigations do not include the [name] [address] [phone number] of the complainant. Specifically, ***
337721 CFR 820.198(e)(3)2Device identification and control numberRecords of complaint investigations do not include device identifications and control numbers used. Specifically, ***
337521 CFR 820.198(e)(1)2Device nameRecords of complaint investigations do not include required information. Specifically, ***
337421 CFR 820.198(d)(3)2Determination of relationship of device to eventInvestigation of MDR reportable complaints did not include a determination of the relationship of the device to the reported incident or adverse event. Specifically, ***
337221 CFR 820.198(d)(1)2Determination of whether device met specificationsInvestigation records of MDR reportable complaints do not include required information. Specifically ***
333321 CFR 820.184(f)2Device identification, control numbersThe device history record does not include [certain] [any] device identifications and control numbers used. Specifically, ***
330921 CFR 820.120(b)2Examination for accuracyLabeling 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, ***
324121 CFR 820.72(b)(1)2Calibration standard traceabilityA calibration standard used for [inspection] [measurement] [test] equipment is not traceable to national or international standards nor is it an independent reproducible standard. Specifically, ***
323921 CFR 820.72(b)2Remedial action - documentationEvaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, ***
323621 CFR 820.72(b)2Procedures - contentCalibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action]. Specifically, ***
322421 CFR 820.70(g)(2)2Periodic equipment inspectionProcedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately] established. Specifically, ***
321621 CFR 820.70(b)2Changes documentedChanges were not [documented] [followed]. Specifically, ***
319821 CFR 820.40(b)2Changes - review and approvalChanges 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, ***
314721 CFR 820.170(a)2Installation instructions, test procedures[Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established. Specifically,***
314221 CFR 820.150(a)2Storage procedures to avoid release of unsuitable productProcedures for controlling the storage of product in storage areas and stock rooms are not adequate to ensure that no obsolete, rejected, or deteriorated product is distributed. Specifically, ***
311321 CFR 820.70(g)2Design and installationEquipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***
303821 CFR 812.150(b)(1)2Sponsor evaluation rpt not timely, distributedReports of the results of evaluation of unanticipated adverse device effects were not all submitted [within 10 working days of receiving notice of the effect] to [FDA] [all reviewing IRBs] [all participating investigators]. Specifically, ***
303421 CFR 812.150(a)(6)2Investigator final reportA final report to the [sponsor] [reviewing IRB] was not submitted [within three months] after [termination] [completion] of the investigation. Specifically, ***
303221 CFR 812.150(a)(5)2Investigator report for lack of informed consentA report to the [sponsor] [reviewing IRB] regarding the use of an investigational device without obtaining informed consent was not submitted [within five working days after the use occurred]. Specifically, ***
302721 CFR 812.150(a)(4)2Investigator non-emergency safety or soundness changesIn a non-emergency situation, [changes to] [deviations from] the investigational plan that could have affected [the scientific soundness of the plan] [the rights, safety, or welfare of human subjects] were initiated without prior approval of the changes from [the sponsor] [FDA] [the IRB] . Specifically, ***
300321 CFR 812.140(b)(6)2Other sponsor records required by FDA inadequateRecords that FDA requires to be maintained for [a category of investigation] [a particular investigation] are not all [accurate] [complete] [current]. Specifically, ***
299321 CFR 812.140(b)(2)2Sponsor device disposition records inadequateRecords 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, ***
299121 CFR 812.140(b)(1)2Sponsor correspondence records inadequateRecords relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA], including required reports are not all [accurate] [complete] [current]. Specifically, ***
297521 CFR 812.110(c)2Investigator did not supervise use of investigational deviceAn investigational device was used for subjects not under the supervision of an authorized investigator. Specifically, ***
297221 CFR 812.110(a)2Informed consent obtained prior to study approvalWritten informed consent of potential subjects to participate in an investigation was obtained prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, ***
293521 CFR 812.43(b)2Sponsor shipped devices to unqualified person(s)Investigational devices were shipped to individuals who were not qualified investigators participating in the investigation. Specifically, ***
260021 CFR 820.30(d)2Acceptance criteria not identifiedAcceptance criteria for design outputs were not identified. Specifically, ***
227921 CFR 820.20(b)(2)2ResourcesAdequate resources have not been provided for performing [management activities] [work] [assessment activities] [audits]. Specifically, ***
227021 CFR 820.20(a)2Implement quality policyNot all employees [know there is] [understand] [fully implement] the quality policy. Specifically, ***
79621 CFR 803.55(a)2Initial Submission of Baseline ReportA baseline report on FDA Form 3417 or approved electronic equivalent was not submitted following the first MDR report on a device model. Specifically, ***
75021 CFR 803.52(b)(4)2Date of Report by the Initial ReporterAn individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of report by the initial reporter. Specifically, ***
74921 CFR 803.52(b)(3)2Date of EventAn individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of the event. Specifically, ***
73521 CFR 803.50(b)(2)2Explanation of Incomplete InformationAn MDR report with incomplete information was submitted to FDA without a statement explaining why such information was incomplete and the steps taken to obtain the information. Specifically, ***
1451721 CFR 812.35(a)(1)1No approval for changes requiring prior approval[FDA] [IRB] approval was not obtained for changes to an investigational plan that require prior approval. Specifically, ***
917621 CFR 809.20(b)1Compliance with GMPIn vitro diagnostic products are not being manufactured in accordance with the good manufacturing practices set forth in the Quality System Regulation. Specifically, ***
684921 CFR 812.5(a)1Label does not contain required informationThe label for an investigational device does not include [the name and place of business of manufacturer, packer, or distributor] [the quantity of contents] [the statement "CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use."]. Specifically, ***
680521 CFR 807.25(b)1Device activities not reportedDevice activities have not been reported to FDA. Specifically, ***
680421 CFR 807.21(b)1Listing not updatedExisting device information changed, but the listing was not updated during [June] [December] (or earlier) as required. Specifically, ***
680221 CFR 807.21(a)1Annual registrationYour annual registration [is not current] [was not updated within 30 days of receipt of form FDA 2891a from FDA]. Specifically, ***
443621 CFR 803.40(a)1Report of death, injury by marketed deviceThe importer failed to submit a report to FDA on FDA form 3500A, with a copy to the manufacturer, within 30 days after receiving information that one of its marketed devices may have caused or contributed to a [death] [serious injury]. Specifically, ***
443221 CFR 803.18(d)(3)1Distributor complaint files locationsThe device distributor does not maintain the device complaint files at the distributor's principal business establishment. Specifically, ***
420721 CFR 806.10(d)1Notification of extended actionNo amended notification with required information was submitted within 10 working days of initiating an extension of the correction or removal action. Specifically,***
420021 CFR 806.10(c)(7)1Event descriptionThe events that led to reporting and/or conducting the correction or removal actions were not described. Specifically,***
416721 CFR 820.70(g)1Specified requirementsEquipment used in the manufacturing process does not meet specified requirements. Specifically, ***
406121 CFR 820.20(b)(3)(ii)1Management representative's reportsThe management representative has not [fully] reported on the quality system performance to management with executive responsibility. Specifically, ***
384021 CFR 820.72(b)(1)1In-house calibration standardsIn the absence of a national or international standard, or an independent reproducible standard, no in-house standard has been established for [inspection] [measuring] [test] equipment. Specifically, ***
383921 CFR 820.70(a)(4)1Approval of process equipmentProcess equipment has not been approved. Specifically, ***
370621 CFR 820.250(b)1Review of sampling methods for adequacyThe review of sampling methods for adequacy for their intended use was not documented. Specifically, ***
369821 CFR 820.150(b)1Procedures - receipt and dispatchProcedures were not established for authorizing receipt from and dispatch to storage areas and stock rooms. Specifically, ***
369721 CFR 820.150(a)1Stock rotation, assessment before releaseProduct was not stored to facilitate proper stock rotation and to assess its condition as appropriate. Specifically, ***
369121 CFR 820.100(a)(4)1Verification vs validationThere is no corrective and preventive action procedure to determine when verification can be conducted in lieu of validation. Specifically, ***
367221 CFR 820.30(c)1Design input review and approvalDesign input requirements were not [reviewed] [approved] by designated individual(s). Specifically, ***
342921 CFR 820.75(b)(1)1Performed by qualified individualA validated process was not performed by a qualified individual. Specifically, ***
341921 CFR 820.70(a)(4)1Approval of processProcesses have not been approved. Specifically, ***
341821 CFR 820.70(a)(3)1Standards or codesProcess controls do not include testing devices for compliance with applicable standards or codes, as required by device specifications. Specifically, ***
340421 CFR 820.80(e)(5)1EquipmentAcceptance records did not identify the equipment used in the tests. Specifically, ***
340321 CFR 820.80(e)(4)1SignatureAcceptance records did not include the signature of the individual performing the acceptance activities. Specifically, ***
338521 CFR 820.25(b)(1)1Training on defectsEmployees have not been made aware of device defects that could occur when they improperly perform their jobs. Specifically, ***
337321 CFR 820.198(d)(2)1Determination of use for treatment or diagnosisInvestigation of MDR reportable complaints did not include a determination of whether the device was being used for treatment or diagnosis. Specifically, ***
335521 CFR 820.198(f)1Records accessible to manufacturing siteInvestigated complaints and records of investigation were not accessible to the manufacturing establishment. Specifically, ***
334621 CFR 820.200(b)1Statistical analysis {see also 820.100(a)(1)}Service reports were not analyzed following appropriate statistical methods. Specifically, ***
334321 CFR 820.198(e)1MaintainedRecords of complaint investigations are not maintained by the formally designated unit. Specifically, ***
333121 CFR 820.181(e)1DMR installation/maintenance/servicing proceduresA device master record has not been [adequately] maintained. Specifically, ***
332421 CFR 820.170(b)1Installer's documentation of resultsThe person installing the device did not document complete inspection and test results to demonstrate proper installation. Specifically, ***
331121 CFR 820.120(c)1StorageLabels were stored such that mix-ups were possible. Specifically, ***
326721 CFR 820.861MaintainedThe acceptance status of product was not clearly identified throughout [manufacturing] [packaging] [labeling] [installation] [servicing] of the product. Specifically, ***
323721 CFR 820.72(b)1Remedial actionWhen 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, ***
323021 CFR 820.70(i)1Validation of changes to automated process softwareChanges to software used as part of [production] [the quality system] were not [adequately] validated before approval and issuance. Specifically, ***
321021 CFR 820.651Documentation of control numbers {see also 820.184}Control numbers for [implantable or life supporting devices] [appropriate components] were not documented in the device history record. Specifically, ***
320221 CFR 820.40(b)1Changes, communicationApproved changes were not communicated to appropriate personnel in a timely manner. Specifically, ***
317521 CFR 820.1861QSR contentThe quality system record has not been [adequately] maintained Specifically ***
313821 CFR 820.1301PackagingDevice 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, ***
306521 CFR 812.140(a)(5)1Additional investigator records FDA requiresRecords 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, ***
306421 CFR 812.140(a)(4)1Investigator protocol records inadequateCopies maintained of the study protocol are not all [accurate] [complete] [current]. Specifically, ***
305721 CFR 812.150(b)(8)1Sponsor report of use without informed consentA copy of a report from an investigator regarding use of an investigational device without obtaining informed consent was not submitted to FDA [within five working days of receipt]. Specifically, ***
305421 CFR 812.150(b)(7)130-day sponsor notification to FDAFDA was not notified [within 30 working days] of the [completion] [termination] of a significant risk device study. Specifically, ***
305221 CFR 812.150(b)(6)1Sponsor notif. of rqst. to return/repair/dispose not madeNotification was not sent to [FDA] [all reviewing IRBs] of a request that an investigator [return] [repair] [dispose of] any units of a device. Specifically, ***
304621 CFR 812.150(b)(4)1No 6-month sponsor reports of current investigatorsCurrent lists of the names and addresses of all investigators participating in an investigation were not [always] submitted to FDA at six month intervals after FDA approval of the investigation. Specifically, ***
300221 CFR 812.140(b)(5)1Sponsor records of adverse device effects & complaintsRecords concerning [anticipated adverse device effects] [unanticipated adverse device effects] [complaint] reports are not all [accurate] [complete] [current]. Specifically, ***
299421 CFR 812.140(b)(3)1Sponsor records of investigator agreements inadequateSigned investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current]. Specifically, ***
298321 CFR 812.140(a)(2)(iii)1Investigator records of disposition of devices inadequateRecords that relate to the [reason why devices] [quantity of devices that] were [returned to the sponsor] [repaired] [disposed of] are not all [accurate] [complete] [current]. Specifically, ***
294221 CFR 812.43(c)(4)(iii)1No informed consent statement in investigator agreementA signed agreement that includes a statement of the investigator's commitment to ensure that the requirements for obtaining informed consent are met was not obtained from each participating investigator. Specifically, ***
293921 CFR 812.43(c)(3)1No research termination info in investigator agreementA signed agreement, that includes an explanation of the circumstances that led to the termination of any investigations in which the investigator was involved, was not obtained from each participating investigator. Specifically, ***
293821 CFR 812.43(c)(2)1No info on relevant experience in investigator agreementA signed agreement that includes the specifics of the investigator's relevant experience was not obtained from each participating investigator. Specifically, ***
293721 CFR 812.43(c)(1)1No curriculum vitae in investigator agreementThe signed investigator agreements obtained from each participating investigator do not all include the investigator's curriculum vitae. Specifically, ***
292421 CFR 812.20(a)(2)1Initiation of study prior to FDA IDE approvalFDA approval was not obtained prior to initiation of an investigation for which an FDA-approved IDE was required. Specifically, ***
292321 CFR 812.20(a)(1)1Did not submit IDE application to FDAAn application was not submitted to FDA when [a significant risk device investigation was to be undertaken] [an investigation that involves exception from informed consent was intended] [FDA sent notification that an application was required for an investigation]. Specifically, ***
291621 CFR 812.7(d)1Investigational device represented as safe and /or effectiveAn investigational device was represented as being [safe] [effective] for the purposes for which it [is] [was] being investigated. Specifically, ***
291021 CFR 812.7(a)1Promotion or test marketingAn investigational device was [promoted] [test marketed] prior to FDA approval/clearance. Specifically, ***
80921 CFR 803.55(b)(9)1Quantity Manufactured and DistributedA baseline report submitted on FDA Form 3417 did not contain [the number of devices manufactured and distributed in the last 12 months] [an estimate of the number of devices in current use]. Specifically, ***
79721 CFR 803.55(b)1Annual Update of Baseline ReportsA baseline report was not updated annually, on the anniversary month of the initial submission, after the initial baseline report was submitted. Specifically, ***
79321 CFR 803.53(a)1Firm Did Not Submit 5 Day ReportA 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, ***
78621 CFR 803.52(f)(9)1Remedial Action Reported per Section 519An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether remedial action was reported as a removal or correction under Section 519(f) of the FD&C Act, and listing the correction/removal report number. Specifically, ***
78521 CFR 803.52(f)(8)1Use of device not indicated in Block HAn individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether use of the device was initial, reuse, or unknown. Specifically, ***
78421 CFR 803.52(f)(7)1Remedial Action TakenAn individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether remedial action was taken and type. Specifically, ***
78121 CFR 803.52(f)(4)1Date of Device ManufactureAn individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H the date of device manufacture. Specifically, ***
77421 CFR 803.52(e)(4)1Date Received by ManufacturerAn individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block G the date received by the manufacturer. Specifically, ***
76621 CFR 803.52(d)(1)1Name, Address & Phone of Initial ReporterAn individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block E the [name] [address] [phone number] of the reporter who initially provided information. Specifically, ***
73421 CFR 803.50(b)(2)1Providing Incomplete or Missing InformationThe firm did not obtain and provide FDA with information that is incomplete or missing from reports submitted by user facilities, distributors, and other initial reporters. Specifically, ***
65421 CFR 803.20(a)(2)1Sections G and H not completed by mfr.The device manufacturer did not complete Sections G and H on the back side of FDA Form 3500A. Specifically, ***
64221 CFR 803.18(b)(1)(i)1Adverse events--all info not in fileMDR 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, ***
64121 CFR 803.18(a)1Identification and filing of MDR FilesMDR event files have not been [prominently identified as such] [filed to facilitate timely access]. Specifically, ***
64021 CFR 803.18(a)1Event files--failure to establishMDR event files have not been established and maintained. Specifically, ***
63621 CFR 803.17(b)(2)1Reports and information documentationThe written MDR procedure does not include documentation and recordkeeping requirements for all Medical Device Reports and information submitted to [FDA] [device manufacturers]. Specifically, ***

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Drugs

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Drugs110521 CFR 211.22(d)127Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***
358521 CFR 211.110(a)106Control procedures to monitor and validate performanceControl 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, ***
202721 CFR 211.19297Investigations of discrepancies, failuresThere 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, ***
360321 CFR 211.160(b)84Scientifically sound laboratory controlsLaboratory 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, ***
136121 CFR 211.100(a)83Absence of Written ProceduresThere 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, ***
135821 CFR 211.100(b)82SOPs not followed / documentedWritten production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, ***
188321 CFR 211.165(a)61Testing and release for distributionTesting 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, ***
200921 CFR 211.18860Prepared for each batch, include complete informationBatch 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, ***
111221 CFR 211.25(a)60Training--operations, GMPs, written proceduresEmployees 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, ***
121521 CFR 211.67(b)54Written procedures not established/followedWritten 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, ***
241921 CFR 211.198(a)53Complaint Handling ProcedureProcedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed]. Specifically, ***
121321 CFR 211.67(a)53Cleaning / Sanitizing / MaintenanceEquipment 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, ***
431421 CFR 211.84(d)(2)50Reports 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, ***
194321 CFR 211.180(e)(1)44Review of representative number of batchesWritten 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, ***
457621 CFR 211.19243No written record of investigationWritten records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications]. Specifically, ***
127421 CFR 211.68(a)43Calibration/Inspection/Checking not doneRoutine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, ***
202621 CFR 211.19242Quality control unit review of recordsDrug 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, ***
189021 CFR 211.165(e)41Test methodsThe [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, ***
117721 CFR 211.6341Equipment Design, Size and LocationEquipment 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, ***
191421 CFR 211.166(a)40Lack of written stability programThere is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***
438921 CFR 211.198(a)39Procedures to be written and followedProcedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, ***
439121 CFR 211.180(e)(2)38Items to cover on annual reviewsWritten 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, ***
113321 CFR 211.25(a)38GMP Training FrequencyGMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them. Specifically, ***
435221 CFR 211.160(b)(4)37Calibration - at intervals, written program, remedial actionThe 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, ***
437221 CFR 211.188(b)(8)35Labeling control records including specimens or copiesBatch 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, ***
357021 CFR 211.100(a)35Approval and review of proceduresWritten procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit]. Specifically, ***
178721 CFR 211.80(a)34Procedures To Be in WritingWritten procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***
176721 CFR 211.137(a)32Expiration date lackingDrug 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, ***
202821 CFR 211.19230Extent of discrepancy, failure investigationsInvestigations 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, ***
122721 CFR 211.67(c)30Cleaning/maintenance records not keptRecords are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, ***
900121 CFR 211.22(a)29Lack of quality control unitThere is no quality control unit. Specifically, ***
191221 CFR 211.166(a)28Written program not followedThe written stability testing program is not followed. Specifically, ***
183321 CFR 211.84(d)(1)28Identity Testing of Each ComponentThe 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, ***
430321 CFR 211.67 b)27Written procedures fail to includeWritten 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, ***
188521 CFR 211.165(b)26Microbiological testingEach batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, ***
192021 CFR 211.166a)(3)25Valid stability test methodsThe written stability program for drug products does not include [reliable] [meaningful] [specific] test methods. Specifically, ***
360221 CFR 211.160(a)24Deviations from laboratory control requirementsDeviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified]. Specifically, ***
357221 CFR 211.100(b)24Procedure Deviations Recorded and JustifiedDeviations from written production and process control procedures are not [recorded] [justified]. Specifically, ***
180921 CFR 211.160(a)24Following/documenting laboratory controlsEstablished [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***
154021 CFR 211.125(a)24Strict control not exercised over labeling issuedStrict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, ***
145121 CFR 211.113(b)24Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***
203121 CFR 211.194(a)23Complete test data included in recordsLaboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Specifically, , ***
441321 CFR 211.194(a)(8)22Second person sign offLaboratory 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, ***
434021 CFR 211.14222Written warehousing procedures established/followedProcedures describing the warehousing of drug products are not [established] [followed]. Specifically, ***
357121 CFR 211.100(a)22Changes to Procedures Not Reviewed, ApprovedChanges to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***
673221 CFR 314.80(c)(1)(i)21Late submission of 15-day reportNot 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, ***
200721 CFR 211.186(a)21Signature and checking of records -- 2 personsThe 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, ***
194221 CFR 211.180(e)21Records reviewed annuallyRecords 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, ***
145021 CFR 211.113(a)21Procedures for non-sterile drug productsProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed]. Specifically, ***
203421 CFR 211.194(d)20Laboratory equipment calibration recordsLaboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices]. Specifically, ***
197521 CFR 211.18220Written records kept in individual logsWritten records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, ***
155021 CFR 211.125(f)20Procedures Written and FollowedProcedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***
673021 CFR 314.80(b)19Failure to develop written proceduresWritten procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences. Specifically, ***
440221 CFR 211.19219Written record of investigation incompleteWritten 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, ***
261921 CFR 211.198(b)(2)17Complaint Investigation/Follow-Up FindingsComplaint records are deficient in that they do not include the findings of the [investigation] [follow-up]. Specifically, ***
181021 CFR 211.160(a)17Lab controls established, including changesThe 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, ***
440621 CFR 211.194(a)(2)16Suitability of testing methods verifiedThe suitability of all testing methods is not verified under actual conditions of use. Specifically, ***
436821 CFR 211.188(b)(12)16Investigations made into any unexplained discrepancyBatch 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, ***
430621 CFR 211.80(a)16Written Procedures Not FollowedWritten procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***
189121 CFR 211.165(f)16Failing drug products not rejectedDrug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, ***
162621 CFR 211.13016Procedures are written, and followedProcedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed]. Specifically, ***
111121 CFR 211.25(a)16Training , Education , Experience overallEmployees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions. Specifically, ***
433621 CFR 211.15015Written distribution procedureWritten distribution procedures are not [established] [followed]. Specifically, ***
358321 CFR 211.110(a)15Written in-process control proceduresWritten 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, ***
354721 CFR 211.46(b)15Equipment for Environmental ControlEquipment 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, ***
180121 CFR 211.84(a)15Components withheld from use pending releaseEach 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, ***
356521 CFR 211.5814Buildings not maintained in good state of repairBuildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair. Specifically, ***
126121 CFR 211.68(a)14Written calibration / inspection records not keptRecords of the [calibration checks] [inspections] of automatic, mechanical or electronic equipment, including computers or related systems are not maintained. Specifically, ***
440121 CFR 211.186(b)(9)13Complete 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, ***
434221 CFR 211.142(b)13Storage under appropriate conditionsDrug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected. Specifically, ***
430721 CFR 211.80(d)13Status of Each Lot IdentifiedEach lot of [components] [drug product containers] [closures] was not appropriately identified as to its status in terms of being quarantined, approved or rejected. Specifically, ***
220521 CFR 211.186(b)(9)13Manufacturing Instructions and SpecificationsThe 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, ***
192621 CFR 211.166(b)13Adequate number of batches on stabilityAn 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, ***
149521 CFR 211.122(a)13Written procedures describing in detailThere is a lack of written procedures describing in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of labeling and packaging materials. Specifically, ***
145221 CFR 211.113(b)13Validation lacking for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include [adequate] validation of the sterilization process. Specifically, ***
139521 CFR 211.10313Actual vs. theoretical yields not determinedActual 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, ***
113421 CFR 211.25(b)13Supervisor Training/Education/ExperienceIndividuals 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, ***
437321 CFR 211.188(b)(7)12Actual yield, % of theoretical yieldThe 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, ***
436921 CFR 211.188(b)(11)12Identification of persons involved, each significant stepBatch 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, ***
361321 CFR 211.160(b)(4)12Establishment of calibration proceduresProcedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed]. Specifically, ***
144821 CFR 211.11112Establishment of time limitationsTime limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, ***
891121 CFR 314.81(b)(1)(ii)11Failure to meet specificationsAn 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, ***
436621 CFR 211.188(a)11Accurate reproduction includedBatch 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, ***
200821 CFR 211.186(a)11Written procedures followedProcedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, ***
200321 CFR 211.184(c)11Individual inventory recordRecords 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, ***
188621 CFR 211.165(c)11Sampling and testing plans not describedSampling 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, ***
435721 CFR 211.166(a)10Results not used for expiration dates, storage cond.Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, ***
435321 CFR 211.160(b)(4)10Instruments, apparatus, et. al. not meeting specsThe use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed. Specifically, ***
363921 CFR 211.20410Returned drug procedures in writing and followedProcedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed]. Specifically, ***
126321 CFR 211.68(b)10Computer control of master formula recordsAppropriate 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, ***
683121 CFR 314.80(c)(2)9Late submission of quarterly safety reportsNot all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter. Specifically, ***
438021 CFR 211.198(b)(3)9Determination not to conduct investigation of complaintThe written record did not include the [reason an investigation was found not to be necessary] [name of the responsible person making the determination not to conduct an investigation] when an investigation into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] was not conducted. Specifically, ***
431521 CFR 211.84(d)(2)9Testing Each Component for Conformity with SpecsEach component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, ***
359221 CFR 211.110(c)9In-process materials characteristics testingIn-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, ***
356121 CFR 211.56(b)9Written sanitation procedures lackingThere 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, ***
203321 CFR 211.194(c)9Testing 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, ***
200121 CFR 211.184(b)9Component Test RecordsThe [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, ***
197621 CFR 211.1829Specific information required in individual logsIndividual equipment logs do not show [time] [date] [product] [lot number of each batch processed]. Specifically, ***
150521 CFR 211.122(d)9Label storage access limited to authorized personnelAccess to the storage area for labels and labeling materials is not limited to authorized personnel. Specifically, ***
138821 CFR 211.101(d)9Component addition checked by 2nd personEach component is not added to a batch by one person and verified by a second person. Specifically, ***
441821 CFR 211.42(b)8Adequate space lacking to prevent mix-ups and contaminationThe 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, ***
439921 CFR 211.186(b)(7)8Theoretical yield statement including percentagesMaster 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, ***
437821 CFR 211.188(b)(2)8Identity of major equipment and lines usedBatch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product produced. Specifically, ***
437721 CFR 211.188(b(3)8Identification of each component or in-process materialBatch 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, ***
437021 CFR 211.188(b)(10)8Records of any sampling performedBatch production and control records do not include a record of any sampling performed, for each batch of drug product produced. Specifically, ***
362321 CFR 211.170(a)8Active ingredient retained sample keptA sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained]. Specifically, ***
358221 CFR 211.105(a)8Identification of containers, lines, equipmentAll [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, ***
355921 CFR 211.56(a)8Sanitation--buildings not clean, free of infestationBuildings 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, ***
179021 CFR 211.80(b)8Handling and Storage to Prevent ContaminationThere was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination. Specifically, ***
145421 CFR 211.115(a)8Reprocessing procedures not written or followedProcedures 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, ***
127021 CFR 211.68(b)8input/output verificationInput to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, ***
116921 CFR 211.42(a)8Buildings of Suitable Size, Construction, LocationBuildings 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, ***
116221 CFR 211.28(a)8Protective Apparel Not WornProtective apparel is not worn as necessary to protect drug products from contamination. Specifically, ***
103321 CFR 211.22(a)8Authority lacking to review records, investigate errorsThe quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred]. Specifically, ***
1002121 CFR 314.98(a)7(Flag to indicate ANDA applicant)(DO NOT PRINT ON FDA 483. This cite is to be used as a flag to indicate that the recipient of an FDA 483 involving ADE reporting is the applicant for one or more approved ANDAs, as opposed to approved NDAs. No specifics text is required for this cite.)
441021 CFR 211.194(a)(5)7Calculations performed are in the recordsLaboratory records do not include a record of all calculations performed in connection with the test. Specifically, ***
438821 CFR 211.198(a)7Complaints reviewed by Quality Control UnitWritten 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, ***
363221 CFR 211.170(b)7Annual visual exams of drug productsReserve 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, ***
192221 CFR 211.166(a)(4)7Testing in same container - closure systemThe 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, ***
180221 CFR 211.84(b)7Representative SamplesRepresentative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination. Specifically, ***
163721 CFR 211.130(e)7Packaging line inspection after useInspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable for subsequent operations have been removed. Specifically, ***
163321 CFR 211.130(d)7Examination of packaging and labelingExamination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not documented in the batch production records]. Specifically, ***
143421 CFR 211.42(c)(10)(iv)7Environmental Monitoring SystemAseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***
119421 CFR 211.42(c)7Defined areas of adequate size for operationsThe [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***
683221 CFR 314.80(c)(2)6Late submission of annual safety reportsNot all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application. Specifically, ***
682321 CFR 314.80(c)6Failure by applicant to report ADEAdverse drug experience information has not been reported to FDA. Specifically, ***
441221 CFR 211.194(a)(7)6Signatures and dates--person who performs testLaboratory records do not include [the initials or signature of the person who performs each test] [the date(s) the tests were performed]. Specifically, ***
440021 CFR 211.186(b)(8)6Description 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, ***
437521 CFR 211.188(b)(5)6In-process and laboratory control resultsBatch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced. Specifically, ***
436721 CFR 211.188(b)(13)6Examinations for correct labelingBatch production and control records do not include results of examinations made of packaged and labeled products for correct labeling. Specifically, ***
433821 CFR 211.150(b)6Recall facilitationA 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, ***
362921 CFR 211.170(b)6Reserve samples identified, representative, storedReserve 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, ***
361621 CFR 211.165(d)6Acceptance criteria for sampling & testingAcceptance 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, ***
344521 CFR 211.65(a)6Equipment construction - reactive surfacesEquipment 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, ***
240121 CFR 211.194(a)(4)6Complete Test DataLaboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***
220021 CFR 211.186(b)(4)6Variation in the Amount of Components UsedThe master production and control records are deficient in that they lack a justification for the variation in the amount of components used in the preparation of a dosage form. Specifically, ***
204421 CFR 211.1966Distribution Record RequirementsDistribution 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, ***
184421 CFR 211.84(d)(2)6Establish reliability of supplier's C of AEstablishment 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, ***
179821 CFR 211.82(b)6Quarantine Storage of ComponentsIncoming [components] [drug product containers] [closures] are not stored under quarantine until they have been tested or examined, as appropriate, and released. Specifically, ***
177421 CFR 211.142(a)6Quarantine - actual practiceDrug products are not quarantined before being released by the quality control unit. Specifically, ***
163221 CFR 211.130(c)6Lot or control number assignedThe 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, ***
154621 CFR 211.125(d)6Destruction of excess labels with lot numbersExcess labeling bearing lot or control numbers is not destroyed. Specifically, ***
139321 CFR 211.1036Yield calculations not verified by 2nd personYield calculations are not performed by one person and independently verified by a second person. Specifically, ***
116821 CFR 211.346Consultant RecordsRecords are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided]. Specifically, ***
109821 CFR 211.22(c)6Approve or reject procedures or specsThe quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products. Specifically, ***
104921 CFR 211.22(a)6Approve or reject components, productsThe 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, ***
890721 CFR 314.81(b)(1)(ii)5Contamination, chemical or physical change, deteriorationAn 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, ***
440521 CFR 211.194(a)(2)5Statement of methods and dataLaboratory records do not include a statement of [each method used in the testing of a sample] [the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested]. Specifically, ***
440421 CFR 211.194(a)(1)5Sample identification and other informationLaboratory 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, ***
437421 CFR 211.188(b)(6)5Inspection of packaging and labeling areaBatch production and control records do not include results of the inspection of the packaging and labeling area [before] [after] use for each batch of drug product produced. Specifically, ***
435421 CFR 211.165(d)5Acceptance/Rejection LevelsThe statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels]. Specifically, ***
432321 CFR 211.115(a)5Reprocessing procedures lack steps to be takenReprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics. Specifically, ***
432021 CFR 211.84(d)(6)5Microbiological Contamination ExamEach 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, ***
359421 CFR 211.110(d)5Rejected in-process materials not quarantinedRejected 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, ***
354821 CFR 211.46(c)5Air filtration system lacking in production areaThe production area air supply lacks an appropriate air filtration system. Specifically, ***
261821 CFR 211.198(b)(1)5Complaint Record required informationComplaint records are deficient in that they do not include the known [name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant]. Specifically, ***
242021 CFR 211.198(a)5Quality Control ReviewComplaint 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, ***
220321 CFR 211.186(b)(7)5Theoretical Yield and PercentagesThe master production and control records are deficient in that they do not include a statement of theoretical yield and [minimum] [maximum] [yield percentages]. Specifically, ***
203521 CFR 211.194(e)5Stability testing records not includedLaboratory records do not include complete records of all stability testing performed. Specifically, ***
195721 CFR 211.180(e)(2)5Review of problem drugsThe 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, ***
192821 CFR 211.166(c)(1)5Homeopathic drugs, assessment of stabilityThere is no written assessment of stability of homeopathic drug products based at least on [testing or examination of the drug product for compatibility of the ingredients] [marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use]. Specifically, ***
191821 CFR 211.166(a)(2)5Stability sample storage conditions describedThe written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically, ***
191721 CFR 211.166(a)(1)5Sample size - test intervalsThe 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, ***
187921 CFR 211.180(c)5Records not made readily available to FDARecords 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, ***
186921 CFR 211.94(c)5Containers & Closures Clean, Sterilized, Pyrogen-freeDrug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use. Specifically, ***
179121 CFR 211.80(c)5Storage off Floor, Spaced SuitablyBagged or boxed components of drug product [containers] [closures] are not [stored off the floor] [suitably spaced to allow cleaning and inspection]. Specifically, ***
172521 CFR 211.134(c)5Examinations documentedThe results of the examination of the packaged and labeled products were not documented in the batch production or control records. Specifically, ***
891221 CFR 314.81(b)(2)4Timely submissionAn 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, ***
673621 CFR 314.80(c)(1)(ii)4Submission of report follow-upFollow-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, ***
440921 CFR 211.194(a)(4)4Data secured in course of each testLaboratory 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, ***
437121 CFR 211.188(b)(9)4Description of containers and closuresBatch production and control records do not include a description of drug product [containers] [closures] used for each batch of drug product produced. Specifically, ***
436421 CFR 211.1764Failing to test for penicillin cross-contaminationNon-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, ***
434321 CFR 211.160(b)(1)4Incoming 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, ***
432421 CFR 211.110(b)4In-process materials specifications testingExamination and testing of samples is not done to assure that in-process materials conform to specifications. Specifically, ***
432221 CFR 211.101(d)4Component release checked by 2nd personEach 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, ***
359121 CFR 211.110(b)4In-process materials specificationsIn-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, ***
356921 CFR 211.894Quarantine 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, ***
256721 CFR 211.198(a)4Adverse Drug ExperienceComplaint 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, ***
192721 CFR 211.166(b)4Accelerated stability studiesAccelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not supported with ongoing full shelf life studies. Specifically, ***
185121 CFR 211.84(e)4Rejecting When Specifications Not MetFailure 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, ***
180321 CFR 211.84(b)4Representative Samples CriteriaThe [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria. Specifically, ***
179721 CFR 211.82(a)4Examination on receipt, before acceptanceEach 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, ***
163621 CFR 211.130(e)4Packaging line inspection before useInspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all drug products have been removed from previous operations. Specifically, ***
144921 CFR 211.1114Deviations of production time limitsDeviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product]. Specifically, ***
141121 CFR 211.105(b)4Distinctive ID or code not recorded in batch recordThe 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, ***
139621 CFR 211.42(c)(2)4Rejected Material AreaSeparate 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,***
126621 CFR 211.42(d)4Penicillin processing area not kept separateThe 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, ***
108621 CFR 211.22(b)4Adequate lab facilities not availableAdequate 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, ***
107921 CFR 211.22(a)4Contract drug products--lack of responsibilityThe quality control unit lacks responsibility for approving or rejecting drug products [manufactured] [processed] [packed] [held] under contract by another company. Specifically, ***
684021 CFR 314.80(f)(1)3Wrong form - domestic ADEAn FDA Form 3500A has not been completed for each report of a domestic adverse drug experience. Specifically, ***
682921 CFR 314.80(c)(2)3Failure to report non-alert ADEsIndividual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report. Specifically, ***
673521 CFR 314.80(c)(1)(ii)3Failure to investigate serious, unexpected eventsAdverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated. Specifically, ***
441421 CFR 211.2043Record information maintainedRecords of returned drug products are not maintained. Specifically, ***
441121 CFR 211.194(a)(6)3Test results, comparison with standards not includedLaboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the [component] [drug product container] [closure] [in-process material] [drug product] tested. Specifically, ***
440821 CFR 211.194(a)(3)3Weight or measure of sampleLaboratory records do not include a statement of the weight or measure of sample used for each test, where appropriate. Specifically, ***
438221 CFR 211.198(b)(2)3Written record of complaint to include findings, follow-upWritten records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up]. Specifically, ***
437621 CFR 211.188(b)(4)3Weights and measures of components usedBatch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced. Specifically, ***
435921 CFR 211.170(a)(1), (b)(1)3Retention time of reserve samples, in generalReserve samples for [active ingredients] [drug products] are not retained for one year after the expiration date of the drug product.
435621 CFR 211.166(b)3Tentative expiration dateWhere data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no [stability studies] [drug product testing at appropriate intervals] conducted until the tentative expiration date was verified or the appropriate expiration date determined. Specifically, ***
435521 CFR 211.165(c)3Sampling and testing plans not followedWritten procedures for sampling and testing plans are not followed for each drug product. Specifically, ***
435021 CFR 211.160(b)(3)3Drug products-sampling procedures/specificationsLaboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products. Specifically, ***
434121 CFR 211.142(a)3Quarantine - written proceduresWritten procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit. Specifically, ***
432721 CFR 211.122(c)3Records fail to includeRecords kept for each different labeling and packaging material shipment fail to include [the receipt] [results of examination or testing] [a statement of whether the shipment was accepted or rejected]. Specifically, ***
432521 CFR 211.110(a)3Control procedures fail to include the followingControl 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,***
431621 CFR 211.84(d)(3)3Testing Containers & Closures Conformity with SpecsContainers and closures are not tested for conformance with all appropriate written procedures. Specifically, ***
430421 CFR 211.68(b)3Written record not kept of program and validation dataA 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, ***
363021 CFR 211.170(b)3Drug product reserve containersDrug 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, ***
358121 CFR 211.101(d)3Verification of component additionEach component is not added to the batch by one person and verified by a second person.. Specifically, ***
357321 CFR 211.101(b)3Measured components for manufacturingComponents for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate]. Specifically, ***
355721 CFR 211.523Washing and toilet facilities are deficientWashing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness]. Specifically, ***
203221 CFR 211.194(b)3Test method modification records not maintainedComplete records are not maintained of any modification of an established method employed in testing. Specifically, ***
197721 CFR 211.1823Dedicated equipment: records part of batch recordThe records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record. Specifically, ***
195821 CFR 211.180(f)3Responsible firm officials notified in writingProcedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices]. Specifically, ***
193321 CFR 211.167(a)3Sterility/pyrogens - test methods written, followedTest procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed]. Specifically, ******
187621 CFR 211.180(a), (b)3Record 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 are not maintained at least one (1) year after the expiration date. Specifically, ***
186821 CFR 211.94(b)3Protection from external factorsContainer 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, ***
172421 CFR 211.134(b)3Representative samples after completionSamples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations. Specifically, ***
149621 CFR 211.122(a)3Sampling/testing of labeling/packaging materialsLabeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product. Specifically, ***
145621 CFR 211.115(b)3Reprocessing/quality control unitReprocessing was performed without the [review] [approval] of the quality control unit. Specifically, ***
141321 CFR 211.42(c)(5)3Mfg / Processing Operations AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. Specifically, ***
115921 CFR 211.28(a)3Clothing appropriate for duties performedClothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not appropriate for the duties they perform. Specifically, ***
113621 CFR 211.25(c)3Inadequate number of personnelThe number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***
683021 CFR 314.80(c)(2)2IntervalPeriodic 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, ***
672821 CFR 314.80(b)2Failure to review ADE informationAdverse 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, ***
441721 CFR 211.2042Associated batches implicated, investigatedNo appropriate investigation was conducted when a returned drug product appeared to implicate associated batches of drug products. Specifically, ***
441621 CFR 211.2042Reprocessed returned drug productsReturned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety, identity, strength, quality and purity. Specifically, ***
441521 CFR 211.2042Returned drug products with doubt cast as to safety et. al.Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not [destroyed] [subjected to examination, testing or other investigation to prove the drug products do meet all the necessary parameters]. Specifically, ***
440721 CFR 211.194(a)(2)2Reference and method not statedLaboratory records of methods of testing used do not [indicate the method] [provide the reference] when employing methods in [recognized standard references] [an approved new drug application and the referenced method is not modified]. Specifically, ***
438621 CFR 211.198(b)2Written complaint record to be maintained at facilityA 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, ***
434521 CFR 211.160(b)(1)2Samples (various types) representative, identified properlySamples 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, ***
433021 CFR 211.130(e)2Packaging line inspection documentationResults of inspection of packaging and labeling facilities are not documented in the batch production records. Specifically, ***
432821 CFR 211.122(a)2Written procedures not followedWritten procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed. Specifically, ***
432121 CFR 211.101(b)2Identification of new containersFor components removed from the original containers, the new container fails to be identified with [component name or item code] [receiving or control number] [weight or measure] [batch for which component was dispensed including product name, strength and lot number]. Specifically, ***
431721 CFR 211.84(d)(3)2Certificates 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, ***
430221 CFR 211.56(b)2Written sanitation procedures not followedWritten procedures for sanitation are not followed. Specifically, ***
364121 CFR 211.2042Record information inclusionsRecords 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, ***
363121 CFR 211.170(b)2Investigation of reserve sample deteriorationEvidence of reserve drug product sample deterioration was not [investigated] [recorded and maintained with other stability data]. Specifically, ***
361421 CFR 211.160(b)(4)2Written calibration proceduresWritten 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, ***
361121 CFR 211.160(b)(3)2Acceptance of drug productsDeterminations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products. Specifically, ***
356021 CFR 211.56(a)2Trash and organic waste timely disposalThere is no provision to hold and dispose of [trash] [organic waste matter] in a timely and sanitary manner. Specifically, ***
355321 CFR 211.48(a)2Plumbing System DefectsThe plumbing system contains defects that could contribute to the contamination of drug products. Specifically, ***
355121 CFR 211.46(d)2Penicillin air handling systems not kept separateAir-handling systems for the [manufacture] [processing] [packing] of penicillin are not completely separate from those for other drug products for human use. Specifically, ***
202421 CFR 211.188(b)(12)2Documentation of Batch InvestigationsThe batch production and control records are deficient in that they do not include documentation of batch investigations performed. Specifically, ***
202021 CFR 211.188(b)(8)2Labeling Control Records and Label CopiesThe batch production and control records are deficient in that they do not include [complete labeling control records] [specimen] [copy] of labeling. Specifically, ***
201921 CFR 211.188(b)(7)2Documentation of Actual Yield and Theoretical YieldThe batch production and control records are deficient in that they do not include a statement of the [actual yield] [percentage of theoretical yield]. Specifically, ***
200421 CFR 211.184(d)2Labeling: documentation of exam and reviewThere 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, ***
197821 CFR 211.1822Personnel dating/signing equipment logThe persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log. Specifically, ***
193821 CFR 211.167(c)2Controlled release dosage form testingEach batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient. Specifically, ***
185221 CFR 211.94(a)2Reactive/Additive/Absorptive Containers/ClosuresDrug 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, ***
184221 CFR 211.84(d)(1)2Component identity verificationDrug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. Specifically,***
179621 CFR 211.80(d)2Identification of Each Lot in Each ShipmentEach 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, ***
179421 CFR 211.80(d)2Disposition recorded by lot identificationThe distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot. Specifically, ***
177721 CFR 211.150(b)2Distribution Recall SystemThe distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary. Specifically, ***
172821 CFR 211.872Retest of approved components/containers/closuresApproved [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, ***
172221 CFR 211.134(a)2Correct labels during finishing operationsPackaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. Specifically, ***
163021 CFR 211.130(b)2Unlabeled filled containers controlsFilled 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, ***
150921 CFR 211.122(h)2Printing devicesPrinting devices used to imprint labeling upon the drug product [unit label] [case] are not monitored to assure that all imprinting conforms to the print specified in the batch production record. Specifically, ***
149821 CFR 211.122(b)2Labeling and packaging improperly approved/releasedLabeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use]. Specifically, ***
143321 CFR 211.42(c)(10)(iii)2Air SupplyAseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, ***
140921 CFR 211.42(c)(4)2In-Process Material AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials. Specifically, ***
138421 CFR 211.101(c)2Weighing/measuring/subdividing operationsComponent [weighing] [measuring] [subdividing] operations are not adequately supervised. Specifically, ***
125621 CFR 211.68(b)2Backup file not maintainedFailure to maintain a backup file of data entered into the computer or related system. Specifically, ***
122421 CFR 211.67(b)(6)2Cleaning SOP/inspectionProcedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. Specifically, ***
122021 CFR 211.67(b)(3)2Cleaning SOPs/instructionsProcedures 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, ***
891421 CFR 314.81(b)(2)(iv)(b)1Mfg and control changes not requiring a supplemental app.An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.Specifically, ***
891021 CFR 314.81(b)(2)(iii)1Labeling informationAn annual report did not include [currently used professional labeling] [patient brochures or package inserts] [a representative sample of the package labels] [a summary of any changes in labeling that have been made since the last report, listed by date in the order in which they were implemented, or if no changes, a statement of that fact].   Specifically, ***
890621 CFR 314.81(b)(1)(i)1Mix-upAn NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be [mistaken for] [applied to] another article. Specifically, ***
683821 CFR 314.80(e)(1)1Failure to report post-marketing study ADEsFifteen-day Alert reports have not been submitted for all adverse drug experiences during post marketing studies, where there was a reasonable possibility that the drug caused the adverse experience. Specifically, ***
683521 CFR 314.80(d)(1)1Failure to submit scientific articleNot all post marketing 15-day Alert reports based upon scientific literature were accompanied by a copy of the published article. Specifically, ***
683321 CFR 314.80(c)(2)(ii)1Incomplete periodic safety reportNot all periodic reports contained [a narrative summary and analysis of the information in the report] [an analysis of the post marketing 15-day Alert reports submitted during the reporting interval] [an FDA Form 3500A for each adverse drug experience not reported as a post marketing 15-day Alert report] [an index containing a line listing of your patient identification number and adverse reaction term(s)] [a history of actions taken since the last report because of adverse drug experiences]. Specifically, ***
682621 CFR 314.80(c)(1)(iii)1Records not maintained by non-applicantYou, 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, ***
682521 CFR 314.80(c)(1)(iii)1Non-applicant reports to applicantYou, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both serious and unexpected. However, you did not submit each report to the applicant [within five calendar days of your receipt of the information]. Specifically, ***
673721 CFR 314.80(c)(1)(ii)1Failure to separately submit original and follow-up reportsInitial post marketing 15-day Alert reports and follow-up reports have not been submitted under separate cover. Specifically, ***
671421 CFR 310.305(c)(3)1Untimely submission by packer/distributorReports of serious adverse drug experiences were not submitted by a [packer] [distributor] to the manufacturer within 5 calendar days of receipt of the report. Specifically, ***
671021 CFR 310.305(c)(2)1Submission of report follow-upFollow-up reports to post marketing 15-day Alert reports have not been submitted [within 15 calendar days of receipt of new information] [upon request by FDA] . Specifically, ***
670921 CFR 310.305(c)(2)1Investigation of serious, unexpected eventsSerious, unexpected adverse drug experiences have not been [promptly] investigated. Specifically, ***
670621 CFR 310.305(c)(1)(i)1Late submissionEach post marketing 15-day Alert report was not submitted to FDA within 15 calendar days of initial receipt of the information. Specifically, ***
670521 CFR 310.305(c)1Failure to reportAdverse drug experience information has not been reported to FDA. Specifically, ***
440321 CFR 211.194(b)1Test method modification records do not includeRecords 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, ***
439621 CFR 211.186(b)(4)1Variations in component amounts not justifiedThe master production and control records indicate unjustified variations in the amount of components necessary for preparation of the dosage form. Specifically, ***
439221 CFR 211.186(b)(1)1Name, strength, dosage formThe master production and control records do not include [the name and strength of the product] [a description of the dosage form]. Specifically, ***
438721 CFR 211.198(a)1Reporting of adverse drug experience to FDAWritten 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, ***
438321 CFR 211.198(b)(1)1Written complaint record must includeWritten complaint records do not include, where known, [the name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant]. Specifically, ***
438121 CFR 211.198(b)(2)1Written investigation record or copy kept at establishmentThe written record or copy of the record of an investigation of a complaint conducted in relation to [any unexplained discrepancy] [ the failure of a batch or any of its components to meet any of its specifications] is not maintained at the establishment where the investigation occurred.
437921 CFR 211.188(b)(1)1Dates not included for each significant stepBatch 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, ***
436221 CFR 211.170(a)(3), (b)(3)1Retention time for exempt OTC drug productsReserve samples for [active ingredients in OTC drug products] [OTC drug products] which are exempt from bearing an expiration date are not retained for 3 years after the lot or batch of drug product is distributed. Specifically, ***
436021 CFR 211.170(b)1Reserve drug product sample quantity - all testsThe 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, ***
435121 CFR 211.160(b)(3)1Drug products - samples representative, identified properlySamples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified]. Specifically, ***
434921 CFR 211.160(b)(2)1In-process samples representative, identified properlySamples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified]. Specifically, ***
434821 CFR 211.160(b)(2)1In-process materials - sampling, testing proceduresLaboratory controls do not include a description of [sampling] [testing] procedures for in-process materials. Specifically, ***
434621 CFR 211.160(b)(1)1Retesting when subject to deteriorationProcedures designed to assure conformance to written specifications do not require appropriate retesting of [components] [drug product containers] [closures] subject to deterioration. Specifically, ***
434421 CFR 211.160(b)(1)1Sampling and testing procedures describedWritten specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used. Specifically, ***
432921 CFR 211.122(b)1Rejection of unapproved labeling/packaging materialsLabeling or packaging materials which did not meet written specifications were not rejected to prevent their use in operations for which they are unsuitable. Specifically, ***
431321 CFR 211.84(c)(6)1Containers Marked to Show Samples TakenContainers from which samples have been taken are not marked to show that samples have been taken from them. Specifically, ***
431121 CFR 211.84(c)(4)1Compositing of Sub SamplesComponents which must be sampled from top, middle and bottom of the container are not kept separate, but instead are composited for testing. Specifically, ***
364021 CFR 211.2041Returned drug products identified and heldReturned drug products are not [identified as such] [held]. Specifically, ***
362521 CFR 211.170(a)(1)1Retention time for reserve samples of activesReserve samples of active drug ingredients are deficient in that they are not retained at least one year after the expiration date of the last lot of the drug containing the active drug ingredient. Specifically, ***
361521 CFR 211.160(b)(4)1Test devices not meeting specificationsTest devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used. Specifically, ***
360921 CFR 211.160(b)(2)1In-process sample representation/identificationIn-process samples are not [representative] [properly identified]. Specifically, ***
360821 CFR 211.160(b)(2)1Sampling/testing of in-process materialsThe specifications for in-process materials are deficient in that they do not include a description of the [sampling plan] [testing procedures] for in-process materials. Specifically, ***
359821 CFR 211.132(b)(1)1OTC products requiring tamper-evident packagingOTC 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, ***
358921 CFR 211.110(a)(4)1Dissolution time and rateThe in-process control procedures are deficient regarding examination of dissolution time and rate. Specifically, ***
358821 CFR 211.110(a)(3)1Mixing adequacyThe 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, ***
356221 CFR 211.56(c)1Written 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, ***
355821 CFR 211.521Washing and toilet facilities not provided and accessibleWashing and toilet facilities are not [provided] [easily accessible to working areas]. Specifically, ***
355021 CFR 211.46(c)1Exhaust systems inadequate to control air contaminationAdequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production. Specifically, ***
354621 CFR 211.46(a)1Adequate ventilation not providedAdequate ventilation is not provided. Specifically, ***
354521 CFR 211.441Adequate lighting not providedAdequate lighting is not provided in all areas. Specifically, ***
262121 CFR 211.198(b)(3)1Reason for Not Conducting Complaint InvestigationComplaint records are deficient in that they do not document the reason and the individual making the decision not to conduct a complaint investigation. Specifically, ***
256921 CFR 211.198(b)1Maintenance of Complaint FileComplaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints. Specifically, ***
240621 CFR 211.194(a)(8)1Identification of Person Performing Review of Lab RecordsLaboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy. Specifically, ***
240521 CFR 211.194(a)(7)1Identification of Person Performing the TestingLaboratory 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, ***
219921 CFR 211.186(b)(4)1Component Weight and MeasureThe master production and control record are deficient in that they do not include an accurate statement of [weight] [measure] of each component, using the same weight system for each component. Specifically, ***
219721 CFR 211.186(b)(2)1Active Ingredient Name and WeightThe master production and control records are deficient in that they do not include the [name] [weight] of each active ingredient per dosage unit or unit of weight statement of total weight or measure of any dosage unit. Specifically, ***
208921 CFR 211.2081No records maintainedNo records are maintained for salvaged drug products. Specifically, ***
208621 CFR 211.2081Salvaging and return to marketplaceDrug products that have been subjected to improper storage conditions were salvaged and returned to the marketplace without further evidence or inspection. Specifically, ***
202321 CFR 211.188(b)(11)1Identification of Persons Performing Significant StepsThe 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, ***
201821 CFR 211.188(b)(6)1Documentation of Packaging and Labeling Area InspectionsThe 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, ***
201121 CFR 211.188(a)1Accurate reproductionThe 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, ***
200521 CFR 211.184(e)1Records of disposition of rejected materialRecords do not include the disposition of rejected [components] [drug product containers] [closures] [labeling]. Specifically, ***
197921 CFR 211.1821Chronological Order of Equipment Log EntriesThe entries in the equipment cleaning and use logs are not in chronological order. Specifically, ***
192921 CFR 211.166(c)(2)1Homeopathic drugs, same container - closureThe evaluation of the stability of homeopathic drug products is not based on the same container-closure system in which the drug product is being marketed. Specifically, ***
187021 CFR 211.94(d)1Written Procedures to Remove PyrogensThere are no written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilization] [methods of processing] to remove pyrogenic properties. Specifically, ***
184321 CFR 211.84(d)(2)1Component written specificationComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, ***
181921 CFR 211.84(c)(3)1Sterile/Aseptic Techniques for SamplingSampling procedures are deficient regarding sterile equipment and aseptic sampling techniques when sampling [components] [drug product containers] [closures]. Specifically, ***
176821 CFR 211.137(b)1Storage conditionsDrug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies. Specifically, ***
172621 CFR 211.861Rotation of components/containers/closuresThere is a lack of rotation so that the oldest approved stock of [components] [drug product containers] [closures] is used first. Specifically, ***
162921 CFR 211.130(a)1Prevention of cross contamination, mix-upsThere is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination. Specifically, ***
154521 CFR 211.125(c)1Label reconciliation discrepancies evaluation/investigationDiscrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated] [investigated]. Specifically, ***
150321 CFR 211.122(c)1Records not kept for each shipmentRecords are not maintained for each shipment received of each different labeling and packaging material. Specifically, ***
143621 CFR 211.42(c)(10)(vi)1Equipment to control conditionsAseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. Specifically, ***
143521 CFR 211.42(c)(10)(v)1Cleaning SystemAseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, ***
143021 CFR 211.42(c)(10)(i)1Floors, walls, ceiling surfacesAseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,***
142121 CFR 211.42(c)(10)1Aseptic Processing AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. Specifically,***
142021 CFR 211.42(c)(9)1Control / Lab Operations AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations. Specifically, ***
141821 CFR 211.42(c)(7)1Quarantined Drug Products AreaSeparate 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, ***
137121 CFR 211.101(a)1Batches Formulated to less than 100%Written production and control procedures include batches formulated with the intent to provide less than 100 percent of the labeled or established amount of active ingredient. Specifically, ***
125121 CFR 211.42(c)(1)1Incoming material areaSeparate 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, ***
121921 CFR 211.67(b)(2)1Cleaning SOPs/schedulesProcedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, ***
117421 CFR 211.42(b)1Product flow through building is inadequateThe flow of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not designed to prevent contamination. Specifically, ***
116721 CFR 211.341Qualifications lackingConsultants lack sufficient education, training and experience to advise on the subject for which they are retained. Specifically, ***
116421 CFR 211.28(c)1Unauthorized Personnel in Limited Access AreasUnauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas. Specifically, ***
116321 CFR 211.28(b)1Habits of good sanitation & healthProduction personnel were not practicing good sanitation and health habits. Specifically, ***

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Bioresearch monitoring

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Bioresearch monitoring756021 CFR 312.60128FD-1572, protocol complianceAn investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically***
753021 CFR 312.62(b)77Case history records- inadequate or inadequateFailure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent]. Specifically, ***
752621 CFR 312.62(a)30Accountability recordsInvestigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***
731821 CFR 56.115(a)(2)29Minutes of IRB meetingsMinutes 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, ***
722721 CFR 50.27(a)26Consent form not approved/signed/datedInformed 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, ***
728121 CFR 56.108(a)(1)26Initial and continuing reviewsThe IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***
729021 CFR 56.108(c)18Members present for reviewFor 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, ***
749821 CFR 312.6618Unanticipated problemsFailure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.  Specifically, ***
734221 CFR 56.108(b)(2)15Prompt reporting of noncomplianceThe 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 theses regulations or the requirements or determinations of the IRB.  Specifically, ***
733421 CFR 56.115(a)(5)14List of membersA 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, ***
723121 CFR 50.2013Consent not obtained, exceptions do not applyLegally 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, ***
756221 CFR 312.6013Informed consentFailure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting study-related tests] . Specifically***
729321 CFR 56.109(f)10Continuing reviewThe IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of not less than once per year].  Specifically, ***
732121 CFR 56.110(c)10Method to keep members advisedThe 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, ***
755221 CFR 312.6610Changes in researchNot all changes in research activity were approved by an Institutional Review Board prior to implementation.  Specifically, ***
727821 CFR 56.107(e)9Conflict of interestThe 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, ***
728621 CFR 56.108(b)(1)9Prompt reporting of unanticipated problemsThe 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, ***
733521 CFR 56.115(a)(6)9Written 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, ***
734321 CFR 56.108(b)(3)9Reporting  of suspension/terminationThe 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, ***
731721 CFR 56.115(a)(1)8Copies of all research proposals and related documentsCopies 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, ***
748221 CFR 312.508General responsibilities of sponsorsFailure 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, ***
734021 CFR 56.108(a)(3)7Prompt reporting of changesThe IRB [has no] [did not follow its] written procedure for ensuring prompt reporting to the IRB of changes in research activity.  Specifically, ***
739121 CFR 50.25(a)(5)7Confidentiality, FDA inspection of recordsThere 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, ***
400621 CFR 58.120(b)6Protocol: approval of changesNot all changes in, or revisions of, an approved protocol and the reasons therefore were documented, signed by the study director, dated, and maintained with the protocol. Specifically, ***
736821 CFR 56.108(a)2)6More frequent reviews, verification of no changesThe 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, ***
736921 CFR 56.109(h)6Children as subjectsThe IRB did not determine [at the time of initial review] [at the time of continuing review for an on-going study which was started on/before April 30, 2001] that a study was in compliance with 21 CFR Part 50 Subpart D, "Additional Safeguards for Children in Clinical Investigations."  Specifically, ***
739021 CFR 50.25(a)(4)6Alternate procedures, courses of treatmentThere 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, ***
751721 CFR 312.666Initial and continuing reviewFailure 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, ***
752021 CFR 312.64(b)6Safety reportsFailure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused by, or probably caused by, an investigational drug. Specifically, ***
395621 CFR 58.63(c)5Equipment: maintenance recordsAdequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations.  Specifically, ***
731621 CFR 56.115(a)(4)5Copies of IRB/CI correspondenceCopies have not been maintained of all correspondence between the IRB and the investigators. Specifically, ***
732021 CFR 56.109(e)5IRB approvals/disapprovals - generalThe IRB has not promptly notified in writing [the investigator] [the institution] when the IRB has [approved] [disapproved] [required modifications to secure IRB approval of] proposed research activity.   Specifically, ***
737121 CFR 56.108(a)(1)5Reporting findings and actions to investigator/institutionThe IRB [has no] [did not follow its] written procedure for reporting its [findings] [actions] to the [investigator] [institution].  Specifically, ***
752721 CFR 312.62(a)5Unused drug disposition (investigator)Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions].  Specifically, *** 
765221 CFR 56.1135ReportingThe IRB's [suspension] [termination of approval] for research was not reported [promptly] to [the investigator] [appropriate institutional officials] [the Food and Drug Administration].  Specifically, ***
765421 CFR 56.110(b)5Research not eligible for expedited reviewThe 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, ***  
391421 CFR 58.31(f)4Management: personnel understand their functionsTesting facility management failed to assure that all personnel clearly understood the functions they were to perform.  Specifically, ***
392321 CFR 58.33(f)4Study director: transfer of data to archivesThe 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, ***
393121 CFR 58.35(b)(5)4QAU: authorize deviations from protocols or SOPsThe 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, ***
395121 CFR 58.514Facility: archivesSpace is not provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies. Specifically, ***
395221 CFR 58.614Equipment: appropriate design and adequate capacityNot all [equipment used in the generation, measurement, or assessment of data] [equipment used for facility environmental control] is of appropriate design and adequate capacity to function according to the protocol and is suitably located for operation, inspection, cleaning, and maintenance. Specifically, ***
396021 CFR 58.81(b)4SOPs: requiredStandard operating procedures have not been established for [animal room preparation] [animal care] [receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles] [test system observations] [laboratory tests] [handling of animals found moribund or dead during study] [necropsy of animals or postmortem examination of animals] [collection and identification of specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment] [transfer, proper placement, and identification of animals].  Specifically, ***
397721 CFR 58.90(g)4Animal care: analysis of feed and waterNot all animal feed and water were analyzed periodically to ensure that expected contaminants were not present at levels above those specified in the protocol. Specifically, ***
399721 CFR 58.120(a)(4)4Protocol: test system descriptionNot all protocols contained the number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.  Specifically, ***
400721 CFR 58.130(a)4Conduct: in accordance with protocolNot all nonclinical laboratory studies were conducted in accordance with the protocol.  Specifically, ***
727921 CFR 56.107(f)4Invited individual allowed to vote with IRBThe 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, ***
731921 CFR 56.115(a)(3)4Records of continuing reviewRecords have not been [prepared] [maintained] of all continuing review activities. Specifically, ***
735321 CFR 50.524Factors required for approvalThe IRB approved a clinical investigation in which more than minimal risk to children was presented by 1) an intervention or procedure that held out the prospect of direct benefit for the individual subjects, and/or 2) by a monitoring procedure which was likely to contribute to the individual subjects' well-being. However, the IRB did not [find] [document] that [the risk was justified by the anticipated benefit to the subjects] [the relation of the anticipated benefit to the risk was at least as favorable to the subjects as that presented by available alternative approaches] [adequate provisions had been made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 21 CFR 50.55]. Specifically, ***
737021 CFR 56.111(c)4Children as subjectsThe 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, ***
739221 CFR 50.25(a)(7)4Whom to contactThe 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, ***
745921 CFR 312.57(a)4Records of receipt, shipment, dispositionLack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug.  Specifically, ***
748021 CFR 312.504Ensuring compliance with plan and protocolFailure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.  Specifically, ***
748821 CFR 312.594Records of unused drug dispositionFailure to maintain [adequate] written records of the disposition of an investigational drug in accordance with 21 CFR Part 312.57.  Specifically, ***
753121 CFR 312.62(c)4Record retentionInvestigational 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, ***
391821 CFR 58.33(a)3Study director: follow study protocolThe study director failed to assure that the protocol, including any change, was approved and was followed.  Specifically, ***
392021 CFR 58.33(c)3Study director: unforeseen circumstancesThe study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented. Specifically, ***
392621 CFR 58.35(b)(1)3QAU: maintain a master scheduleThe quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility.  Specifically, ***
393221 CFR 58.35(b)(6)3QAU: review final study reportThe 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, ***
395321 CFR 58.63(a)3Equipment: inspection, cleaning and maintenanceNot all equipment is adequately inspected, cleaned, and maintained. Specifically, ***
395421 CFR 58.63(a)3Equipment: calibrationNot all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized.  Specifically, ***
395821 CFR 58.81(a)3SOPs: authorization and documentation of deviationsNot all deviations from standard operating procedures in a study were authorized by the study director and  documented in the raw data.  Specifically, ***
399921 CFR 58.120(a)(6)3Protocol: experimental designNot all protocols contained a description of the experimental design, including the methods for the control of bias.  Specifically, ***
401221 CFR 58.130(e)3Conduct: date and signNot all data entries were dated on the date of entry and signed or initialed by the person entering the data.  Specifically, ***
401621 CFR 58.185(a)3Final report: non-existentA final report was not prepared for each nonclinical laboratory study. Specifically, ***
403721 CFR 58.190(b)3Archives: conditions of storageConditions 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, ***
732421 CFR 56.111(a)(4)3Informed consent soughtThe 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, ***
763821 CFR 312.20(a)3Failure to submit an INDThe sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***
766421 CFR 50.203Circumstances of obtaining consentThe 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, ***
766621 CFR 50.203Understandable languageThe 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, ***
390321 CFR 58.29(b)2Personnel: summary of training, job descriptionThe testing facility failed to maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.  Specifically, ***
391121 CFR 58.31(c)2Management: assure there is a QAUTesting facility management failed to assure that there was a quality assurance unit in conformance with FDA GLP regulations.  Specifically, ***
392521 CFR 58.35(a)2QAU: separate and independentThe quality assurance unit, for any given study, was not entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Specifically, ***
395721 CFR 58.81(a)2SOPs: laboratory methodsThe 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, ***
395921 CFR 58.81(a)2SOPs: authorized changesNot all significant changes in established standard operating procedures were properly authorized in writing by management.  Specifically, ***
397821 CFR 58.90(g)2Animal care: feed and water analysis recordsNot all feed and water analyses for contaminants were maintained as raw data. Specifically, ***.
398321 CFR 58.105(a)2Test article: characterizationThe identity, strength, purity, composition, or other characteristics of each batch of test and control article have not been appropriately defined and documented. Specifically, ***
398521 CFR 58.105(b)2Test article: stabilityThe stability of each test or control article was not determined by the testing facility or by the sponsor before study initiation, or concomitantly according to written standard operating procedures which provide for periodic analysis of each batch.  Specifically, ***
398921 CFR 58.1072Test article: handlingProcedures have not been established for the handling of the test and control articles to ensure that [there is proper storage] [distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage] [proper identification is maintained throughout the distribution process] [the receipt and distribution of each batch is documented including the date and quantity of each batch distributed or returned]. Specifically, ***
401821 CFR 58.185(a)(2)2Final report: objectives, procedures, changesThe final study report did not include the objectives and procedures stated in the approved protocol, including any changes in the original protocol. Specifically, ***
402021 CFR 58.185(a)(4)2Final report: data on test and control articlesThe final study report did not include the test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics.  Specifically, ***
402121 CFR 58.185(a)(5)2Final report: stability of test and control articlesThe final study report did not include the stability of the test and control articles under the conditions of administration.  Specifically, ***
402521 CFR 58.185(a)(9)2Final report: circumstances affecting data qual., integrityThe final study report did not include a description of all circumstances that may have affected the quality or integrity of the data.  Specifically, ***
402821 CFR 58.185(a)(12)2Final report: reports of individual scientistsThe final study report did not include the signed and dated reports of each of the individual scientists or other professionals involved in the study.  Specifically, ***
403521 CFR 58.190(a)2Archives: data, documentation, specimensNot 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, ***
727421 CFR 56.107(a)2At least five members with varying backgroundsThe IRB is not composed of at least five members [with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution].   Specifically, ***
729721 CFR 56.109(b)2Information given to subjectsThe IRB does not require that information given to subjects as part of informed consent contain all necessary elements of informed consent.  Specifically, ***:
730521 CFR 56.110(b)(2)2Minor changesThe IRB used an expedited review procedure to review supposedly minor changes to previously-approved research, but the changes were not minor in nature. Specifically, ***
730921 CFR 56.111(a)(1)2Risks minimized by sound research designThe IRB approved the conduct of research, but did not determine that risks to subjects were minimized by using procedures which were consistent with sound research design and which did not unnecessarily expose subjects to risk. Specifically, ***
732521 CFR 56.111(a)(5)2Informed consent documentedThe IRB approved the conduct of research, but did not determine that informed consent would be appropriately documented.  Specifically, ***
737221 CFR 56.115(b)2Access to recordsRecords required to be maintained under 21 CFR 56 were not accessible for [inspection] [copying] by authorized representatives of the FDA.  Specifically, ***
738721 CFR 50.25(a)(1)2Statement of research, purpose, duration of participationThe informed consent document did not contain [a statement that the study involved research] [an explanation of the purposes of the research, and the expected duration of the subject's participation].  Specifically, ***
738821 CFR 50.25(a)(2)2Reasonably foreseeable risks or discomfortsThe informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject.  Specifically, ***
741121 CFR 312.53(c)(1)2Investigator statement (FDA 1572)Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation. Specifically, ***
755521 CFR 312.53(d)2Selecting monitorsMonitors not qualified by experience and training were selected to monitor the progress of a clinical investigation.   Specifically, ***
 
765021 CFR 56.1132Authority of the IRBThe IRB lacks authority to [suspend] [terminate approval of] research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.  Specifically, ***
765621 CFR 56.108(c)2Approval from a majority of members presentFor other than expedited reviews, research approved by the IRB does not always receive the approval of a majority of those IRB members present.  Specifically, ***
390021 CFR 58.101Notifying contractor of GLP statusNot all consulting laboratories, contractors, or grantees were notified that the study must be conducted in compliance with FDA GLP regulations. Specifically, ***
390221 CFR 58.29(a)1Personnel: education, training, experienceNot all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions. Specifically, ***
390421 CFR 58.29(c)1Personnel: sufficient numberThe testing facility did not have a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.  Specifically, ***
390921 CFR 58.31(a)1Management: designating the study directorTesting facility management failed to designate a study director before each study was initiated. Specifically, ***
391221 CFR 58.31(d)1Management: testing of test and control articlesTesting facility management failed to assure that all test and control articles or mixtures had been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.  Specifically, ***
391721 CFR 58.331study director: overall study responsibilityThe study director did not have overall responsibility for the technical conduct of the study as well as for the interpretation, analysis, documentation and reporting of results, and does not represent the single point of study control. Specifically, ***
391921 CFR 58.33(b)1Study director: all data recorded and verifiedThe study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified. Specifically, ***
392221 CFR 58.33(e)1Study director: follow GLP regulationsThe study director failed to assure that all applicable GLP regulations were followed. Specifically, ***
392421 CFR 58.35(a)1QAU: monitor facilities, etc.The quality assurance unit did not monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP regulations.  Specifically, ***
392821 CFR 58.35(b)(3)1QAU: inspect study at adequate intervalsThe quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection.  Specifically, ***
393321 CFR 58.35(b)(7)1QAU: signed statement in final reportThe quality assurance unit failed to prepare and sign a statement to be included with the final study report which specified the dates inspections were made and findings reported to management and to the study director.  Specifically, ***
393421 CFR 58.35(c)1QAU: SOPs and required recordsThe quality assurance unit failed to maintain and make available for inspection required records regarding its responsibilities and procedures and the method of indexing such records.  Specifically, ***
393621 CFR 58.411Facility: suitable size and constructionThe testing facility is not of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies.  Specifically, ***
394621 CFR 58.47(a)(1)1Facility: article receipt and storage areasThe testing facility does not provide separate areas, as necessary, to prevent contamination or mix-ups for receipt and storage of the test and control articles. Specifically, ***
395521 CFR 58.63(b)1Equipment: maintenance SOPsThe standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment are not adequate. Specifically, ***
396221 CFR 58.81(d)1SOPs: historical fileA historical file of standard operating procedures, and all revisions, including the dates of such revisions, was not maintained.  Specifically, ***
396321 CFR 58.831Reagents: labelingNot all reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Specifically, ***
397621 CFR 58.90(f)1Animal care: cage and equipment cleaningNot all animal cages, racks and accessory equipment were cleaned and sanitized at appropriate intervals. Specifically, ***
399021 CFR 58.113(a)(1)1Mixtures: uniformity and concentrationNot all test or control articles mixed with a carrier were tested by appropriate analytical methods to determine [the uniformity of the mixture] [periodically, the concentration of the test or control article in the mixture]. Specifically, ***
399221 CFR 58.113(c)1Mixtures: expiration datingNot all test or control article carrier mixtures [had an expiration date clearly shown on the container] [consisting of  more than one component, had the earliest expiration date clearly shown on the container].  Specifically, ***
399321 CFR 58.120(a)1Protocol: approvedNot all studies had an approved written protocol that clearly indicated the objectives and all methods for the conduct of the study. Specifically, ***
400021 CFR 58.120(a)(7)1Protocol: diet descriptionNot all protocols contained a description and/or identification of the diet used in the study. Specifically, ***
400421 CFR 58.120(a)(11)1Protocol: date and signatureNot all protocols contained the date of approval of the protocol by the sponsor and the dated signature of the study director.  Specifically, ***
400821 CFR 58.130(b)1Conduct: test systems monitoringNot all test systems were monitored in conformity with the protocol.  Specifically, ***
401121 CFR 58.130(e)1Conduct: recording in inkData generated without the use of an automated data collection system were not recorded directly, promptly, and legibly in ink.  Specifically, ***
401721 CFR 58.185(a)(1)1Final report: name, address, datesThe final study report did not include the name and address of the facility performing the study and the dates on which the study was initiated and completed. Specifically, ***
402221 CFR 58.185(a)(6)1Final report: description of methodsThe final study report did not include a description of the methods used. Specifically, ***
402321 CFR 58.185(a)(7)1Final report: description of test systemThe final study report did not include a description of the test system used and, where applicable, the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification. Specifically, ***
402421 CFR 58.185(a)(8)1Final report: dosage, regimen, route of admin., durationThe final study report did not include a description of the dosage, dosage regimen, route of administration, and duration.  Specifically, ***
402621 CFR 58.185(a)(10)1Final report: names of those involvedThe 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, ***
402721 CFR 58.185(a)(11)1Final report: operations on data, analysis of dataThe final study report did not include [a description of the transformations, calculations, or operations performed on the data] [a summary and analysis of the data] [a statement of the conclusions drawn from the analysis]. Specifically, ***
403121 CFR 58.185(b)1Final report: not signed by study directorNot all final reports were signed and dated by the study director.  Specifically, ***
404021 CFR 58.190(d)1Archives: unauthorized personnelUnauthorized personnel entered the archives.  Specifically, ***
404121 CFR 58.190(e)1Archives: indexing, expedient retrievalNot all material retained or referred to in the archives was indexed to permit expedient retrieval. Specifically, ***
404421 CFR 58.195(d)1Archives: maintenance of records by QAUNot all master schedules, copies of protocols, and records of quality assurance inspections were maintained by the quality assurance unit as an easily accessible system of records for the required period of time.  Specifically, ***
404721 CFR 58.195(g)1Archives: records not retained as originals, true copiesNot all required records were retained as original records or as true copies of the original records.  Specifically, ***
720921 CFR 50.25(a)(1)1Procedures, identification of those which were experimentalThe informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were experimental]. Specifically, ***
723321 CFR 50.23(a)1Two written certifications re: no ICA test article was used without informed consent being obtained from a research subject. The investigator and a physician who was not otherwise participating in the investigation did not both certify in writing that [the human subject was confronted by a life-threatening situation necessitating the use of the test article] [informed consent could not  be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject] [time was not sufficient to obtain consent from the subject's legal representative] [there was no alternative method of approved or generally recognized therapy available that would provide an equal or greater likelihood of saving the life of the subject]. Specifically, ***
727021 CFR 56.103(a)1IRB review requirementA clinical investigation requiring prior submission to the FDA was initiated without [IRB review] [IRB approval] [being subject to continuing IRB review]. Specifically, ***
727721 CFR 56.107(d)1One non-affiliate memberThe 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, ***
730421 CFR 56.110(b)(1)1No more than minimal riskThe IRB used an expedited review procedure for research appearing in an FDA list of categories eligible for expedited review, but the reviewer did not find the research involved no more than minimal risk to the subjects.  Specifically, ***
731321 CFR 56.1121Approval by institution in absence of IRB approvalThe institution approved research which had not been approved by the IRB. Specifically, ***
732221 CFR 56.111 (a)(2)1Risks to subjects reasonableThe 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, ***
733321 CFR 56.104(c)1Emergency use and IRB approvalA 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, ***
733721 CFR 56.115(b)1Retention of recordsRecords required by 21 CFR 56 have not been maintained for three years following completion of the research. Specifically, ***
733921 CFR 56.108(a)(4)1Changes in approved researchThe 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, ***
735221 CFR 50.511Provisions for soliciting assent and permissionFor a clinical investigation in which no greater than minimal risk to children as subjects was presented, the IRB did not [find] [document] that adequate provisions had been made for [soliciting the assent of the children] [soliciting the permission of the parents or guardians of the children] as set forth at 21 CFR 50.55. Specifically, ***
735421 CFR 50.531Factors required for approvalThe IRB approved a study in which more than minimal risk to children was presented by [an intervention or procedure that did not hold out the prospect of direct benefit for the subjects] [a monitoring procedure that was not likely to contribute to the well-being of the subjects].  However, the IRB did not [find] [document] that [the risk represented a minor increase over minimal risk] [the intervention or procedure presented experiences to subjects that were reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations] [the intervention or procedure was likely to yield generalizable knowledge about the subjects' disorder or condition that was of vital importance for the understanding or amelioration of the subjects' disorder or condition] [adequate provisions had been made for soliciting the assent of the children and permission of their parents or guardians]. Specifically, ***
736321 CFR 50.55(f) 1Documentation of permission by parents or guardianPermission by parents or guardians for the participation of children as subjects in a clinical investigation was not documented in accordance with and to the extent required by 21 CFR 50.27.  Specifically, ***
736721 CFR 50.55(e)(2)1Two parents' permission: studies under Parts 50.53 - 50.54For 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, ***
738321 CFR 50.25(b)(6)1Number of subjects in studyThe informed consent document did not state the approximate number of subjects involved in the study.  Specifically, ***
738921 CFR 50.25(a)(3)1Benefits to the subjectA description of any benefits [to the subject] [to others] which might reasonably be expected from the research was not included in the informed consent document. Specifically, ***
739321 CFR 50.25(a)(8)1Participation; refusal and discontinuanceThe informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at any time without penalty or loss of benefits to which the subject was otherwise entitled].  Specifically, ***
740621 CFR 56.109(a)1Scope of reviewsThe IRB does not review all research activities covered by the regulations. Specifically, ***
745321 CFR 312.56(b)1Investigator non-complianceAn investigator who did not comply with [the signed agreement] [the general investigational plan] [applicable regulatory requirements] was not [promptly brought into compliance] [terminated].  Specifically, ***
747921 CFR 312.56(a)1Monitoring investigationsFailure to monitor the progress of an investigation conducted under your IND. Specifically, ***
750721 CFR 312.52(a)1Transfer of obligationsTransfer of obligations to a contract research organization [was not described in writing] [did not describe each of the obligations assumed by the contract research organization, where not all obligations were assumed]. Specifically, ***
751921 CFR 312.64(c)1Final study reportAn adequate final report was not provided to the sponsor shortly after completion of the investigator's participation in the investigation.   Specifically, ***
753321 CFR 312.691Controlled substances (investigator)Inadequate precautions to prevent theft or diversion with respect to [storage of] [access to] an investigational drug which is a controlled substance. Specifically, ***
754321 CFR 312.611Unauthorized 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, ***
754521 CFR 312.120(c)1Foreign clinical trialsFailure 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, ***
763221 CFR 312.6(a)1Required label statementThe immediate package of the investigational new drug does not bear a label with the statement "Caution: New Drug- Limited by Federal (or United States) law to investigational use
763421 CFR 312.7(a)1Promotion of Investigational DrugRepresentations were made in a promotional context that the investigational drug is [safe] [effective] for the purposes for which it is under investigation. Specifically, ***
763921 CFR 312.20(b)1Starting a study before IND is in effectThe sponsor began a clinical investigation subject to IND requirements before an IND was in effect. Specifically,***
766521 CFR 50.201Exculpatory language, waiving of rightsThe 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, ***

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Veterinary medicine

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Veterinary medicine4185FDCA 402(a)(4)72Record keepingTreatment records were not [maintained] [complete].Specifically,***
409321 CFR 530.11(d)52Tissue residueCausing 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, ***
7001FDCA 402(a)(4)32Drug inventoryYou lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock]. Specifically, ***
4182FDCA 501(a)(5)29Extra label use w/o veterinary client-patient relationshipUse of [a human] [an animal] drug in a manner contrary to label directions without benefit of a valid veterinary client-patient relationship. Specifically, ***
1442FDCA 402(a)(4)28Records review prior to slaughterFailure 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, ***
429821 CFR 530.11(a)19Rx not followedFailure 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, ***
409721 CFR 530.20(a)(2)(iv)17Tissue residueCausing 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, ***
1360FDCA 501(a)(5)15Expired drugsExpired drug(s) were observed in the drug storage area. Specifically, ***
136621 CFR 530.11(a)15Dosage levelAdministration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship.  Specifically, ***
185021 CFR 225.58(d)14Assay results out of specificationFailure 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,***
4186FDCA 402(a)(4)14System for administration of drugsFailure to have a system to control administration of drug treatments to your animals.  Specifically, ***
181121 CFR 225.58(b)(1)12Three assays per yearPeriodic 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, ***
207621 CFR 225.102(b)(1)12Elements of the MRFThe 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, ***
 
209721 CFR 225.102(b)(4)11Daily review of production recordsThe 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, ***

 
137321 CFR 530.11(a)10Route of administrationAdministration 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, ***
157521 CFR 225.42(b)(4)9Integrity and identityFailure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity. Specifically, ***
146921 CFR 225.20(b)(3)8Pest access minimizedThe building is not constructed to minimize access by [rodents] [birds] [insects] [pests].  Specifically, ***
13508FDCA 402(a)(4)8Medication 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, ***
146621 CFR 225.20(b)(2)7Maintained in clean and orderly conditionBuildings are not maintained in a reasonably clean and orderly manner.  Specifically, ***
192321 CFR 225.65(b)7Reasonable and effective procedures followedAll 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, ***
195521 CFR 225.80(a)7Appropriate labeling for medicated feedMedicated 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, ***
207521 CFR 225.102(b)(1)7Preparation of MRFA  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, ***

 
410021 CFR 530.20(a)(2)(iii)7Identity of treated animalsFailure 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, ***
4184FDCA 501(a)(5)7Conditions of useAdministration of a drug for conditions not [specified in its labeling] [prescribed].  Specifically, ***
454121 CFR 225.42(b)7Adequate procedures establishedAdequate 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, ***
13509FDCA 402(a)(4)7Identity of animalsFailure 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, ***
136221 CFR 530.11(a)6Species or classAdministration 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, ***
149321 CFR 225.30(b)(4)6Calibration of scales and metering devicesFailure to calibrate scales and metering devices [upon installation] [at least once a year after installation] [as frequently as necessary] to insure their accuracy.  Specifically, ***
178221 CFR 225.42(b)(7)6Daily comparison, actual vs theoreticalA 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, ***
413221 CFR 589.2000(d)(1)6Protein blenders, feed manufacturers, distributorsProducts that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants."Specifically, ***
182121 CFR 225.58(b)(1)5First batch assayNo assay was performed on the first batch for the calendar year of medicated feed requiring a medicated feed mill license. Specifically, ***
413721 CFR 589.2000(d)(1)5Maintaining recordsReceipt of materials that contain or may contain protein derived from mammalian tissues, and failure to maintain records sufficient to track the materials throughout their receipt, processing, and distribution.Specifically, ***
414621 CFR 589.2000(e)(1)5Written clean-out proceduresFailure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants.  Specifically, ***
454521 CFR 225.1205Vermin and pest infestationBuildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation. Specifically, ***
137621 CFR 530.11(a)4Frequency and durationAdministration 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, ***
174421 CFR 225.42(b)(6)4Daily inventory record keptFailure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds. Specifically, ***
209321 CFR 225.102(b)(2)(i)-(iv)4Elements 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, ***
411321 CFR 530.12(e)4Withdrawal, withholding, or discard timeFailure 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, ***
414521 CFR 589.2000(e)(1)4Use of clean-out proceduresFailure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***
454721 CFR 225.1304Cleanliness, 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, ***
455721 CFR 225.1584Investigation and corrective actionResults 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, ***
126221 CFR 225.10(b)(2)3Evaluation and supervision of employeesFailure to provide an on-going program of evaluation and supervision of employees in the manufacture of medicated feeds. Specifically, ***
138921 CFR 530.11(a)3Withdrawal periodAdministration 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, ***
146521 CFR 225.20(b)(1)3Building grounds maintenanceThe building grounds are not routinely maintained so that they are reasonably free from [litter, waste, and refuse] [uncut weeds and grass] [improperly stored equipment]. Specifically, ***

 
163821 CFR 225.42(b)(5)3Elements of receipt recordDrug 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, ***
176021 CFR 225.42(b)(6)3Lot number or shipment I.D. numberThe daily inventory records for drugs do not include [the manufacturer's lot number] [the feed manufacturer's shipment identification number].  Specifically, ***
176521 CFR 225.42(b)(6)(i) - (v)3Information requiredDaily 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, ***  
188221 CFR 225.58(e)3Subsequent productionFollowing distribution of a medicated feed which failed to meet its labeled drug potency, subsequent production of that feedwas resumed prior to the establishment of proper control procedures.  Specifically, ***
193021 CFR 225.65(b)(3)3Sequential productionSequential production of medicated feeds is not done on a predetermined basis designed to prevent unsafe contamination of feeds with residual drugs.  Specifically, ***
209821 CFR 225.102(b)(4)3Discrepancies investigated, reportedWhen 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, ***



 
411121 CFR 530.12(c)3Directions for useFailure 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, ***
411521 CFR 530.13(a)3From bulk drugsCompounding an animal drug from a bulk drug. Specifically, ***
455221 CFR 225.1423Adequate procedures for Type A and Type B articlesAdequate 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, ***
1446FDCA 402(a)(4)2Hospital penFailure to [identify] [segregate] [quarantine] treated animals. Specifically, ***
153521 CFR 225.42(b)(2)2Storage of packaged drugsPackaged drugs are not storedin their original closed containers. Specifically, ***
179221 CFR 225.42(b)(7)2DiscrepanciesFailure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage and theoretical drug usage. Specifically, ***
183521 CFR 225.58(c)2Assay results kept one yearFailure to maintain on the premises, originals or copies of all results of assays [including those from State feed control officials or any other governmental agency] for a period of not less than one year after distribution of the medicated feed.  Specifically, ***
195321 CFR 225.80(b)(2)2Maintaining proofread labelProofread 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, ***
207421 CFR 225.102(a)2Lack of MRFFailure to have a  Master Record File for manufacturing a specific product, which provides the complete procedure for manufacturing a specific product. Specifically, ***
223221 CFR 225.115(b)(1)2Maintaining records of complaintsThe 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, ***
223421 CFR 225.115(b)(2)2Records of clinical and other experiencesFailure to  [maintain] [report] records and reports of clinical and other experience with medicated feeds whose manufacture requires a medicated feed mill license. Specifically, ***
409421 CFR 530.11(b)2Use in animal feedAn approved drug was used in or on an animal feed in a manner not in accordance with the approved labeling. Specifically, ***
409921 CFR 530.20(a)(2)(ii)2Extended withdrawal periodA 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, ***
411821 CFR 530.13(b)(3)2Outside of scope of professional practiceCompounding  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, ***
413121 CFR 589.2000(c)(1)(i)2RenderersProducts 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, ***
414421 CFR 589.2000(e)(1)2Separate equipment and facilitiesFailure to maintain separate [equipment] [facilities] for the manufacture, processing, or blending of protein derived from mammalian tissues, to avoid commingling with or cross-contamination of products containing non-mammalian protein.  Specifically, ***
414721 CFR 589.2000(e)(1)2Written product separation proceduresFailure to maintain procedures for separating products which may contain protein derived from mammalian tissues from all other protein products, from the time of receipt until the time of shipment. Specifically, ***
4183FDCA 501(a)(5)2Frequency of administrationAdministration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed].Specifically, ***
454821 CFR 225.1302Scales and metering devicesThe [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision] [accuracy] for their intended purpose.  Specifically, ***
455321 CFR 225.1422Packaged Type A and Type B designated areasThe [packaged Type A medicated articles] [packaged Type B medicated feed] are not [stored in designated areas] [stored in their original closed containers].  Specifically, ***
456021 CFR 225.1652Establishment and use of adequate proceduresAdequate 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, ***
1447FDCA 402(a)(4)1Feeding areasFailure to adequately clean feed and water containers to prevent cross-contamination of medicated and non-medicated feeds and liquids. Specifically, ***
1457FDCA 402(a)(4)1Feeding colostrumFeeding colostrum or milk from treated cows to calves intended for slaughter.  Specifically, ***
146421 CFR 225.20(b)(1)1Adequate drainageThe building grounds are not adequately drained so that they are free from standing water.  Specifically, ***
148221 CFR 225.30(b)(1)1Capability to produce a medicated feedEquipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity]. Specifically, ***
149121 CFR 225.30(b)(2)1Maintenance reasonably clean & orderlyEquipment is not  maintained in a reasonably clean and orderly manner. Specifically, ***
149221 CFR 225.30(b)(3)1Suitable for intended purposeEquipment is not of suitable [size] [design] [construction] [precision] [accuracy] for its intended purpose. Specifically, ***
151021 CFR 225.35(b)1Pesticide manufacture and storageWork areas and equipment used in the [manufacture] [storage] of medicated feeds or components thereof are not physically separated from [work areas] [equipment used] for the [manufacture] [storage] of [fertilizers] [herbicides] [insecticides] [fungicides] [rodenticides] [pesticides]. Specifically, ***
163421 CFR 225.42(b)(5)1Receipt for each lot of drug receivedFailure to [prepare] [maintain] a receipt record for each lot of drug received.  Specifically, ***
177821 CFR 225.42(b)(8)1Maintenance Time RequirementRecords are not maintained on the premises for at least one year after the complete use of a drug component of a specific manufacturer's lot number or shipment identification number. Specifically, ***
188021 CFR 225.58(e)1Distribution discontinuedDistribution of a medicated feed which failed to meet its labeled drug potency was not discontinued.  Specifically, ***
195221 CFR 225.80(b)(2)1Proofreading labels, labeling, placardsIncoming  [labels] [labeling] [placards] are not proofread upon receipt from the printer against the Master Record Files  to verify suitability and accuracy.  Specifically, ***
209121 CFR 225.102(b)(2)1Preparation of Production RecordsThe production record  is not prepared by qualified personnel for each batch or run of medicated feed. Specifically, ***
214021 CFR 225.102(b)(5)1Identification which permits tracing historyFailure to have identification which permits the tracing of the complete and accurate manufacturing history of the product by the manufacturer, including [an individual batch or production run number, code or date] [suitable identification applied to the label, package, invoice or shipping document]. Specifically, *** 
235921 CFR 226.58(e)1Test method reliabilityLaboratory controls do not include adequate provisions to check the [reliability] [accuracy] [precision] of laboratory test procedures. Specifically, ***

 
237621 CFR 226.40(c)1Equipment maintenance and operationEquipment is not [maintained] [operated] in a manner [to avoid contamination of Type A medicated articles] [to insure integrity of the finished products].  Specifically, ***
265821 CFR 226.102(b)(2)1Records do not includeThe batch-production and control records do not include [records of each step in the manufacturing, packaging, labeling and controlling of each batch] [dates] [specific identification of drug components used] [weights or measures of all components] [laboratory control results] [mixing times] [endorsements of the individual actively performing or the individual actively supervising or checking each step in the operation]. Specifically, ***
409821 CFR 530.20(a)(2)(i)1Diagnosis and evaluation of conditionsFailure 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, ***
410921 CFR 530.12(a)1Name and address - drug dispensed by pharmacistFailure 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, ***
411021 CFR 530.12(b)1Names of active ingredientsFailure to provide labeling showing the established name of each active ingredient for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.  Specifically, ***
411221 CFR 530.12(d)1Cautionary statementsFailure to provide labeling containing cautionary statements as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
413421 CFR 589.2000(c)(1)(ii)1Maintaining recordsManufacture of products that contain or may contain protein derived from mammalian tissues, and failure to maintain records sufficient to track the materials throughout their receipt, processing, and distribution. Specifically, ***
415521 CFR 226.1151Appropriate action not takenAppropriate action is not taken as a result of evaluation of complaints on Type A medicated articles. Specifically, ***
415721 CFR 225.42(b)(7)1Detention of feeds with yield discrepanciesMedicated feeds implicated in drug inventory discrepancies based on a comparison of actual vs. theoretical usage are not detained until the discrepancies have been reconciled. Specifically, ***
415821 CFR 225.80(b)(4)1Label stock reviewLabel stock is not [reviewed periodically] [discarded when discontinued labels are found].  Specifically, ***
445321 CFR 225.10(b)(1)1Employees lack understandingAll employees involved in the manufacture of medicated feeds do not have an understanding of the [manufacturing or control operations they perform] [location and proper use of equipment]. Specifically, ***
445421 CFR 225.20(a)1Facilities featuresThe 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, ***
454221 CFR 225.102((a)1Lack of Production Record(s)Failure to have production record(s) for specific products which include the complete history of each batch or production run.Specifically, ***
455421 CFR 225.1421Bulk Type A and Type B storageBulk [Type A medicated articles] [Type B medicated feeds] are not identified and stored in a manner such that their identity, strength, quality and purity will be maintained. Specifically, *** 
455521 CFR 225.1421Use in accord with directionsAll [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled mixing directions. Specifically, ***
455821 CFR 225.1581Records kept for one yearRecords of [investigation] [corrective action] with respect to assays of drug components not meeting permissible levels are not maintained on the premises for a period of one year. Specifically, ***
456221 CFR 225.1801Assuring correct labels are usedLabels are not [received] [handled] [stored] in a manner that [prevents label mix-ups] [assures that the correct labels are used for the medicated feed].  Specifically, ***
456421 CFR 225.1801Bagged or bulk deliveriesAll deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that the feed can be properly used. Specifically, ***
456621 CFR 225.2021Elements of recordsFormula, production and distribution records are not maintained identifying the [formulation] [date of mixing] [date of shipment (if not for own use)].  Specifically, ***
456721 CFR 225.2021Facilitation of recallThe [formula] [production] [distribution] records are not adequate to facilitate the recall of specific batches of medicated feed that have been distributed.  Specifically, *** 
1353421 CFR 511.1(b)(7)(ii)1Records: MaintenanceComplete records of the investigation were not maintained. Specifically, ***

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Biologics

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Biologics7621 CFR 606.100(b)168Maintained and followedWritten standard operating procedures including all steps to be followed in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components for [homologous transfusion] [autologous transfusion] [further manufacturing purposes] are not always [maintained] [followed] [maintained on the premises]. Specifically, ***
9821 CFR 606.100(c)44Thorough investigationsFailure 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,***
442521 CFR 606.60(a)37Equipment observed, standardized, calibratedEquipment 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, ***
15521 CFR 606.160(b)35Required recordsFailure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records. Specifically, ***
16021 CFR 606.160(a)(1)34Person performing, test results, interpretationRecords 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, ***
922521 CFR 606.17127Biological product deviation reportFailure to submit a biological product deviation report [within 45 days from the date you acquired information suggesting that a reportable event occurred]. Specifically, ***
15421 CFR 606.160(a)(1)22Concurrent documentationRecords 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, ***
3121 CFR 606.20(b)20Qualifications of responsible personnelThe 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, ***
16121 CFR 606.160(a)(2)18Determination of lot numbers and suppliesAppropriate records are not available to determine the lot numbers of [supplies] [reagents] used for specific [lots] [units] of the final product. Specifically, ***
6721 CFR 606.65(e)16Following manufacturer's instructionsFailure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.  Specifically, ***
7721 CFR 606.100(b)13Written SOPs available for use by personnelFailure to make available written procedures for use by personnel in the areas where the procedures are performed.  Specifically, ***
7821 CFR 606.100(c)13Record review prior to releaseAll records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.  Specifically, ***
9421 CFR 606.100(b)(15)13Schedules and procedures for equipment & calibrationThe standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration.  Specifically, ***
20821 CFR 640.3(a)(1)13Donor suitability procedures not followedFailure to [follow] [maintain] [maintain on the premises] standard procedures and methods for determining the suitability of a donor as a source of blood. Specifically, ***
904421 CFR 600.10(b)12Personnel capabilitiesFailure 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, ***
5021 CFR 606.40(c)11Provide adequate handwashingFailure to provide [adequate] [clean] [convenient] handwashing facilities for personnel. Specifically, ***
5721 CFR 606.60(a)10Maintain and clean equipmentFailure 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, ***
8921 CFR 606.100(b)(10)10Controlling storage temperaturesThe standard operating procedure fails to include a written description of the storage temperatures and methods of controlling storage temperatures for all blood products and reagents Specifically, ***
15921 CFR 606.160(a)(1)10Legibility and indelibilityRecords are [illegible] [not indelible].  Specifically, ***
22721 CFR 640.4(h)9Storage temperatures after collectionAfter collection, blood is not [immediately stored at a temperature between 1 and 6 degrees Celsius] [transported from the donor clinic to the processing laboratory in temporary storage to cool the blood continuously toward a range between 1 and 6 degrees Celsius]. Specifically, ***
908921 CFR 600.14(c)9When to reportBiological product deviations [were] [are] not reported within the 45 calendar day timeframe.  Specifically, ***
1220221 CFR 606.170(a)9Adverse Reaction - InvestigationsA thorough investigation of each reported adverse reaction was not made.  Specifically,
22421 CFR 640.4(f)8Arm preparationThe phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.  Specifically, ***
908621 CFR 600.14(a)(1)8Who must report - manufacturerFailure to submit [a] biological deviation [report] [reports].  Specifically, ***
1220321 CFR 606.170(a)8Adverse Reaction- Reports of InvestigationsWritten reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained.  Specifically, 
6521 CFR 606.65(c)7Testing of representative samples of reagent lotsRepresentative samples of each lot of [Anti-human globulin] [Blood grouping reagents] [Lectins] [Antibody screening and reverse grouping cells] [Hepatitis test reagents] [Syphilis serology reagents] [Enzymes] are not tested on a regularly scheduled basis as described in the SOP Manual to determine their capacity to perform as required by the regulations.  Specifically, ***
15021 CFR 606.151(e)7Procedures to maintain records of emergency transfusionsRecords [including signature by the physician requesting the procedure] are not maintained of all emergency transfusions [including complete documentation justifying the emergency action].  Specifically, ***
25521 CFR 640.317Donor suitabilityFailure to ensure that [whole blood] [plasmapheresis] donors meet suitability criteria. Specifically, ***
922021 CFR 606.100(b)(20)7Donor notificationThe standard operating procedure fails to include a written description of the [donor notification process] [process for follow-up if the initial attempt at donor notification fails].  Specifically, ***
9321 CFR 606.100(b)(14)6QC procedures for supplies and reagentsThe standard operating procedure fails to include a written description of the quality control procedures for supplies and reagents employed in [blood collection] [processing] [pretransfusion testing].  Specifically, ***
14221 CFR 606.140(a)6Establishment of spec., standards, and test proceduresFailure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective.  Specifically, ***
16521 CFR 606.170(a)6Adverse reaction - Maintenance of ReportsFailure 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, ***
8821 CFR 606.100(b)(9)5Written methods for investigating adverse reactionsThe standard operating procedure fails to include a written description of the procedures for investigating adverse donor and recipient reactions. Specifically, ***
14321 CFR 606.140(b)5Provisions to monitor lab test procedures & instrumentsFailure to establish adequate provisions for monitoring the [reliability] [accuracy] [precision] [performance] of laboratory test procedures and instruments.  Specifically, ***
16721 CFR 606.170(b)5Adverse reaction - fatalityA 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, ***
4121 CFR 606.40(a)(1)4Provide space for examinationFailure to provide adequate space for [private] [accurate] examinations of individuals to determine their suitability as blood donors.  Specifically, ***
6121 CFR 606.60(a)4Provide proper equipment to meet requirementsFailure 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, ***
908721 CFR 600.14(a)(1)4Who must report - receiving informationFailure to [establish] [maintain] [follow] procedures for obtaining information on all [deviations] [complaints] [adverse events] for a distributed biological product subject to biological product deviation reporting.  Specifically, ***
921921 CFR 606.100(b)(20)4Donor deferralThe standard operating procedure fails to include a written description of the donor deferral process.  Specifically, ***
922721 CFR 606.171(a)4BPDR - proceduresFailure to establish a procedure to obtain information about [deviations] [complaints] [adverse events] from your contractor.  Specifically, ***
959621 CFR 640.3(a)4Donor suitability by means of medical historyFailure to [always] determine donor suitability on the day of collection by means of [medical history] [test for hemoglobin level] [physical examination]. Specifically, ***
3521 CFR 606.403Clean & orderlyFailure to maintain facilities in a clean and orderly manner.  Specifically, ***
7521 CFR 606.100(a)3SOP complianceFailure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640. Specifically, ***
8021 CFR 606.100(b)(1)3Donor criteriaThe standard operating procedure fails to include written descriptions of criteria used to determine donor suitability, including acceptable medical history criteria. Specifically, ***
8421 CFR 606.100(b)(5)3Accurate measurement of quantity of bloodThe 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, ***
8521 CFR 606.100(b)(6)3Methods of component preparationThe standard operating procedure fails to include written descriptions of the methods for component preparation, including any time restrictions for specific steps in processing.  Specifically, ***
15621 CFR 606.160(c)3Assignment of donor numberFailure of records describing the history and ultimate disposition of blood products to include a donor number [assigned to each accepted donor] [which relates to the unit of blood collected from that donor] [which relates to the donor's medical record] [which relates to any component or blood product from the donor's unit of blood].  Specifically, ***
15821 CFR 606.160(e)3Unsuitable donorsA record is not available from which unsuitable (deferred) donors may be identified so that products from such individuals will not be distributed. Specifically, ***
20621 CFR 640.3(a)3Donor suitability determined by unqualified personFailure to determine the suitability of a donor as a source of blood by a qualified physician or by a person under his supervision and trained in determining suitability. Specifically, ***
20721 CFR 640.3(a)3Donor suitability not performed on day of collectionFailure to determine the suitability of a donor as a source of blood by a qualified physician or by a trained person under his supervision on the day of collection. Specifically, ***
21521 CFR 640.3(b)(6)3Qualifications of donor - disease transmissible by bloodFailure to determine whether each donor is free from any disease transmissible by blood as determined by history and examinations.  Specifically, ***
33321 CFR 640.64(e)3Prevention of contaminationThe phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood.  Specifically, ***
905221 CFR 600.11(b)3Equipment There is no assurance that equipment is [adequately sterilized] [properly cleaned] [inspected for cleanliness] [suitable for use].  Specifically, ***
924021 CFR 630.6(d)(1)3Physician notificationFailure to provide to an autologous donor's referring physician [information that the autologous donor is deferred based on the results of tests for evidence of infection due to communicable disease agents, and the reason for that decision] [the types of donation of blood and blood components that the autologous donor should not donate in the future] [the results of tests for evidence of infection due to communicable disease agent(s) that were a basis for deferral] [results of any supplemental tests].  Specifically, ***
4321 CFR 606.40(a)(3)2Provide space for storage of blood & blood productsFailure to provide adequate space for the storage of blood or blood components pending completion of tests.  Specifically, ***
4621 CFR 606.40(a)(6)2Provide space for quarantine of unsuitable for use itemsFailure to provide adequate space for the [quarantine] [storage] [handling] [disposition] of [products] and [reagents] not suitable for use.  Specifically, ***
8121 CFR 606.100(b)(2)2Donor qualifying tests & measurementsThe standard operating procedure fails to include written descriptions of methods for performing donor qualifying tests and measurements, including minimum and maximum values for a test or procedure when a factor in determining acceptability. Specifically, ***
8221 CFR 606.100(b)(3)2Preparation of phlebotomy siteThe standard operating procedure fails to include written descriptions of solutions and methods used to prepare the site of phlebotomy to give maximum assurance of a sterile container of blood.  Specifically, ***
11721 CFR 606.121(f)2Labeling of blood products unsuitable for transfusionFailure to prominently label blood and blood components (except for recovered plasma) determined to be unsuitable for transfusion with ["NOT FOR TRANSFUSION"] [the reason the unit is considered unsuitable].  Specifically, ***
16221 CFR 606.165(a)2Distribution and receipt - recallsFailure of distribution and receipt procedures to include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall. Specifically, ***
21121 CFR 640.3(b)(2)2Qualifications of donor - blood pressureEach donor was not in good health as indicated in part by systolic and diastolic blood pressures which were not within normal limits and the examining physician has not determined that this individual with blood pressures outside these limits is otherwise qualified as a donor.  Specifically, ***
24621 CFR 640.25(a)2Storage temps./agitationFailure to store platelets immediately after resuspension [at 20 to 24 degrees Celsius with continuous gentle agitation] [at 1 to 6 degrees Celsius]. Specifically, ***
25121 CFR 640.25(b)2Quality controlFailure to test each month (of manufacture) four units prepared from different donors at the end of the storage period for [platelet count] [pH of not less than 6.0 measured at the storage temperature of the unit] [actual plasma volume]. Specifically, ***
36821 CFR 640.72(d)2Donor reactionFailure 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, ***
37621 CFR 640.1202Alternative proceduresFailure to request from CBER and obtain approval for exceptions or alternatives to requirements regarding [blood] [blood components] [blood products]. Specifically, ***
343821 CFR 600.152Temperatures during shipmentFailure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 degree C or colder] [Cryoprecipitated AHF at -18 degree C or colder] [Liquid Plasma at 1 to 10 degree C] [Plasma at -18 degree C or colder] [Platelets as close as possible to a range between 20 to 24 degree C] [ Red Blood Cells and Whole Blood  between 1 and 10 degree C] [Red Blood Cells, Frozen at -65 degree or colder] [Source Plasma at -5 degree C or colder] [Source Plasma Liquid at 10 degree C or colder]. Specifically, ***
354321 CFR 610.46(a)(1)2Quarantine and notificationWhen a donor tested repeatedly reactive for antibody to human immunodeficiency virus or otherwise was determined to be unsuitable when tested in accordance with the regulations, you did not take appropriate action within 72 hours to [institute a quarantine] [notify your consignee(s) for the purpose of instituting a quarantine] of [whole blood] [blood components] [source plasma] [source leukocytes] collected from the donor.  Specifically, ***
907721 CFR 600.12(a)2Maintenance - completenessThe [manufacturing] [distribution] records [are not legible and indelible] [do not detail the various steps of manufacture of the product].  Specifically, ***
922321 CFR 606.160(b)(6)2Required records - transfusion reaction and complaintsFailure to maintain records of transfusion reaction reports and complaints, including investigation and follow up.  Specifically, ***
923821 CFR 630.6(b)(3)2Results of testingFailure to notify the donor of the results of [tests for evidence of infection due to communicable disease agents that were a basis for deferral] [supplemental tests].  Specifically, ***
926421 CFR 610.40(d)(4)2Autologous donation - labelFailure to label autologous donations with the [name of the donor] [identifying information of the donor] [appropriate caution statement].  Specifically, ***
928821 CFR 640.212Suitability of donorAll [plasmapheresis] [plateletpheresis] donors did not meet the criteria for suitability. Specifically, **
3621 CFR 606.401Suitable size, construction, etc.Failure to provide facilities of  suitable [size] [construction] [location] so as to facilitate adequate cleaning, maintenance and proper operations.  Specifically, ***
4521 CFR 606.40(a)(5)1Provide space for storage of finished productFailure to provide adequate space for the storage of finished products prior to distribution. Specifically, ***
6321 CFR 606.651Safe, sanitary, orderly storageFailure to store all supplies and reagents used in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components in a safe, sanitary and orderly manner.  Specifically, ***
6921 CFR 606.65(a)1Surfaces are sterile, pyrogen free, and non-reactiveFailure to ensure that all surfaces coming in contact with blood and blood components intended for transfusion are [sterile]  [pyrogen-free] [do not interact with the product in such a manner as to have an adverse effect upon the safety, purity, potency or effectiveness of the product].  Specifically, ***
8621 CFR 606.100(b)(7)1Methods for performance of all testsThe standard operating procedure fails to include a written description of all tests and repeat tests performed on blood and blood components during processing. Specifically, ***
8721 CFR 606.100(b)(8)1Methods for pre-transfusion testingThe standard operating procedure fails to include a written description of pretransfusion testing, where pretransfusion testing is applicable, including precautions to be taken to identify accurately the recipient blood samples and crossmatched donor units. Specifically, ***
9121 CFR 606.100(b)(12)1Criteria for suitability of reissue of returned bloodThe standard operating procedure fails to include a written description of the criteria for determining whether returned blood is suitable for reissue. Specifically, ***
9221 CFR 606.100(b)(13)1Procedures to relate blood from donor to final dispositionThe 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, ***
9521 CFR 606.100(b)(16)1Labeling procedures to avoid labeling mix-upsThe standard operating procedure fails to [include a written description of the labeling procedures] [include safeguards to avoid labeling mix-ups]. Specifically, ***
10821 CFR 606.120(c)1Legibility of labelsFailure to utilize clear and legible labeling.  Specifically, ***
11121 CFR 606.120(b)(3)1Utilization of labeling checksFailure to utilize all necessary checks in labeling procedures to prevent errors in translating test results to container labels.  Specifically, ***
12121 CFR 606.121(c)(2)1Name, address, registration numberThe container label fails to include the [name] [address] [registration number] [the license number of each manufacturer, for a licensed product].  Specifically, ***
12421 CFR 606.121(c)(5)1Paid or volunteer donor statementThe container label of the blood product intended for transfusion fails to include the appropriate donor classification statement, i.e., "paid donor" or "volunteer donor."  Specifically, ***
14421 CFR 606.140(c)1Adequate identification and handling of test samplesFailure to adequately provide for identification and handling of all test samples so that they are accurately related [to the specific unit of product being tested] [to its donor] [to the specific recipient].  Specifically, ***
16321 CFR 606.165(b)1Distribution records - contentDistribution records fail to contain information to readily facilitate identification of [the name and address of the consignee] [the date and quantity delivered] [the lot number of the unit(s)] [the date of expiration or date of collection] [the name of the recipient for crossmatched blood and blood components].  Specifically, ***
20521 CFR 640.3(f)1Donations in less than eight weeksA 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, ***
21221 CFR 640.3(b)(3)1Qualifications of donor - hemoglobinEach donor was not in good health as indicated in part by the blood hemoglobin level which was demonstrated to be less than 12.5 gm. of hemoglobin per 100 ml of blood (38% by microhematocrit). Specifically, ***
22121 CFR 640.4(c)1Blood containers and donor setsThe [blood containers] [donor sets] are not [pyrogen-free] [sterile] [identified by lot number] [water repellent when used for processing Heparin Whole Blood]. Specifically, ***
23821 CFR 640.11(a)1General requirements - storageFailure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing.  Specifically, ***
24121 CFR 640.11(b)1General requirements - inspectionFailure to [inspect Red Blood Cells immediately after separation of the plasma, periodically during storage, and at the time of issue] [prevent issuance if Red Blood Cells are abnormal in color, physical appearance, or indicative of microbial contamination].  Specifically, ***
26021 CFR 640.31(b)1Criteria for plasmapheresis donor suitabilityFailure of a plasmapheresis donor to [meet the same criteria for donor suitability as specified for Source Plasma donors (21 CFR 640.63)] [be presented the informed consent].  Specifically, ***
31321 CFR 640.63(e)1Failure to return red blood cellsFailure to defer each donor for eight weeks who has [not had the red blood cells returned from a unit of blood] [been a donor of a unit of whole blood]. Specifically, ***
32121 CFR 640.63(c)(6)1WeightDonor did not weigh 110 pounds or more on the date of donation.  Specifically, ***
32921 CFR 640.64(a)1SupervisionFailure to draw blood from a donor for the collection of Source Plasma by a physician or trained persons under his supervision trained in the procedure. Specifically, ***
36621 CFR 640.72(b)1Cross reference of donor record to unit of plasmaFailure to directly cross-reference each donor record to the unit(s) of the Source Plasma associated with the donor.  Specifically, ***
324821 CFR 640.63(a)1Determining donor suitabilityFailure to have donor suitability determined [by a qualified licensed physician or trained persons under his supervision].  Specifically, ***
325221 CFR 640.63(a)1Determination not made on day of collectionDetermination of the suitability of Source Plasma donors was not made on the day of collection.  Specifically, ***
344321 CFR 610.471Notification of transfusion recipientsFailure to [notify the attending physician of a recipient of a lookback unit] [make a minimum of three attempts within 8 weeks to notify the recipient of a lookback unit in the event the physician does not inform the recipient] [notify recipient's legal representative or relative] [document notifications of lookback units].  Specifically, ***
345121 CFR 601.221Products in Short SupplyFailure of manufacturer to establish that persons/places who conduct initial, and partial manufacturing of a product for shipment solely to such manufacturer are [registered with FDA] [in full compliance with the applicable regulations of this subchapter related to continued safety, purity and potency]. Specifically, ***
345221 CFR 601.12(b)1Major changes to an approved applicationFailure to [submit a supplement] [receive supplement approval from FDA] prior to distributing product made using the change.  Specifically, ***
349821 CFR 640.91(c)1Microbial contaminationProcessing [step] [steps] not conducted in a manner to minimize the risk of contamination. Specifically, ***
354421 CFR 610.46(a)(2)1Quarantine by consigneeWhen you were notified that a donor had tested repeatedly reactive for antibody to human immunodeficiency virus or otherwise had been determined to be unsuitable when tested in accordance with the regulations, you did not take appropriate action to quarantine [whole blood] [blood components] [source plasma] [source leukocytes] collected from the donor.  Specifically, ***
361821 CFR 606.100(b)(19)1Procedure for HIV lookbackThere is no written procedure to look at prior donations of Whole Blood, blood components, Source Plasma, and Source Leukocytes, when a donor of blood subsequently tests repeatedly reactive for antibody to human immunodeficiency virus, or otherwise is determined to be unsuitable when tested in accordance with the applicable regulations.  Specifically, ***
900621 CFR 606.100(b)(19)1Notification of attending physiciansThe written procedures for HIV "lookback" fail to include procedures in accordance with 21 CFR 610.47 to notify attending physicians so that transfusion recipients are informed that they may have received [Whole Blood] [blood components] at increased risk for transmitting HIV.  Specifically, ***
905121 CFR 600.11(a)1Work areas - temperaturesThe [refrigerators] [incubators] [temperature controlled rooms] [are not maintained at the required temperatures] [are not free of extraneous material that may affect the safety of the product].  Specifically, ***
909721 CFR 600.151Blood & Blood ComponentsFailure 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, ***
923521 CFR 630.6(c)1DocumentationFailure to [document that you have successfully notified a deferred donor] [document that you have made reasonable attempts to notify a deferred donor]. Specifically, ***
923621 CFR 630.6(b)(1)1Deferred or not suitableFailure to notify the donor [that the donor is deferred or determined not to be suitable] [of the reason for deferral]. Specifically, ***
925621 CFR 610.411Donor DeferralFailure to defer a donor who tested reactive [by a screening test for evidence of infection due to a communicable disease agent] [for a serological test for syphilis] from further donations of human blood and blood components. Specifically, ***
926221 CFR 610.40(b)1Approved screening testsBlood or blood components were not tested for evidence of infection due to communicable disease agents [using screening tests that the FDA has approved for such use][in accordance with the manufacturer's instructions]. Specifically, ***
927121 CFR 610.411Donor Deferral - reentryThe method or process used to requalify deferred donors was not found acceptable for such purposes by FDA. Specifically, ***
927521 CFR 640.4(g)(5)1AnticoagulantAll segments for compatibility testing did not contain blood mixed with appropriate anticoagulant. Specifically, ***
928521 CFR 640.16(a)1SeparationFailure to prepare Red Blood Cells [in the time frame specified in the directions for use for the system used] [by centrifugation, in a manner that will not tend to increase the temperature of the blood].  Specifically, ***

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Parts 1240 and 1250

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Parts 1240 and 1250703621 CFR 1250.6764Prevention of contaminationFailure 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, ***
703221 CFR 1250.6345Prevention of the spread of communicable diseasesServicing area are not [provided with all necessary sanitary facilities] [operated] [maintained] as to prevent the spread of communicable diseases. Specifically, ***
656921 CFR 1250.33(b)37Equipment kept cleanFailure to keep all equipment clean. Specifically, ***
656021 CFR 1250.32(a)36ContaminationNot all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils]. Specifically, ***
655221 CFR 1250.2828Handling to avoid contaminationIce coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid contamination. Specifically, ***
657021 CFR 1250.33(c)27Storage and handling after bactericidal treatmentFailure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse. Specifically, ***
655821 CFR 1250.30(d)25Plumbing design, installation, maintenancePlumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils]. Specifically, ***
656421 CFR 1250.33(a)23Maintained in good repairNot all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are maintained in good repair. Specifically, ***
658121 CFR 1250.38(b)21Soap, sanitary towels, waterHand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water]. Specifically, ***
658021 CFR 1250.38(b)19SignsSigns directing food-handling employees to wash their hands after each use of toilet facilities are not [posted] [readily observable by such employees]. Specifically, ***
659121 CFR 1250.42(a)19Backflow protectionA water system not protected against backflow. Specifically, ***
657221 CFR 1250.3416ThermometersFailure to equip each refrigerator with a thermometer located in the warmest region thereof. Specifically, ***
657921 CFR 1250.38(a)16Suitable design and constructionFailure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees. Specifically, ***
655521 CFR 1250.30(a)9Clean and free from flies, rodents, and other verminNot all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free from flies, rodents, and other vermin]. Specifically, ***
705521 CFR 1250.75(b)8Equipment for cleaning and flushingEquipment 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, ***
656521 CFR 1250.33(a)7Adequate facilities for cleaning, bactericidal treatmentAdequate 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, ***
656721 CFR 1250.33(b)7Cleaning of multiuse eating and drinking utensilsFailure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] multiuse eating and drinking utensils after each use. Specifically, ***
705121 CFR 1250.75(a)7Contamination of passenger stationsFailure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations]. Specifically, ***
652521 CFR 1240.866Lack of backflow preventionA connection exists between a nonpotable water system on [a vessel] [your vessel] and a potable water system on [a] [your] pier; there are no provisions to prevent backflow from the vessel to the pier.
655421 CFR 1250.30(a)6Ventilation and lightingNot all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated]. Specifically, ***
659321 CFR 1250.42(b)6Connections easily cleanable, located and protectedFilling connections not [easily cleanable] [located and protected] so as to minimize the hazard of contamination of the water supply. Specifically, ***
705321 CFR 1250.75(b)6Sanitary sewers or alternative methodsFailure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal]. Specifically, ***
709021 CFR 1250.82(e)5Backflow prevention - generalLack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment]. Specifically, ***
654921 CFR 1250.274Storage of perishablesFailure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared or kept hot for serving. Specifically, ***
660921 CFR 1250.494Clean and free of flies and mosquitoesNot all conveyances were kept [clean] [free of flies and mosquitoes] while in transit. Specifically, ***
703921 CFR 1250.674Bulk iceEquipment 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, ***
656121 CFR 1250.32(b)3Clean handsPersons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment]. Specifically, ***
656321 CFR 1250.33(a)3Easily cleaned, self-drainingNot 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, ***
658221 CFR 1250.38(b)3Maintained in clean conditionFailure to maintain toilet rooms in a clean condition. Specifically, ***
658621 CFR 1250.393Frequency of dispositionFailure to dispose of [garbage] [refuse] as frequently as necessary and practicable. Specifically, ***
704121 CFR 1250.70(a)3Adequate and readily accessibleAdequate [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, ***
705621 CFR 1250.75(c)3Persons handling soil cans and other containersPersons 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, ***
708921 CFR 1250.82(d)3Identification marks on tanks and pipingNot all [tanks] [piping] bear clear marks of identification. Specifically, ***
658521 CFR 1250.392Containers - close-fitting coversGarbage containers lack close-fitting covers. Specifically, ***
711821 CFR 1250.902Clean conditionToilet and lavatory [equipment] [spaces] not maintained in a clean condition. Specifically, ***
650321 CFR 1240.60(a)1Handled or stored in an insanitary mannerMolluscan shellfish have been [handled] [stored] in such an insanitary manner that [they are likely to become agents in] [their transportation is likely to contribute to] the spread of communicable disease. Specifically, ***
650521 CFR 1240.60(b)1Lack of tag on shellstockShellstock fails to bear a tag that discloses [the date and place they were harvested (by State and site)] [type and quantity of shellfish] [by whom they were harvested]. Specifically, ***
650921 CFR 1240.61(b)1Inadequate pasteurizationPasteurization of [milk] [milk products] does not meet minimum time-temperature requirements. Specifically, ***
653121 CFR 1250.221Clean, wholesome, free from spoilageNot all [food] [drink] served onboard is [clean] [wholesome] [free from spoilage]. Specifically, ***
655721 CFR 1250.30(c)1Water supplyWater [of satisfactory sanitary quality] [under head of pressure] [adequate in amount and temperature] is not easily accessible to all rooms in which [food is prepared] [utensils are cleaned]. Specifically, ***
656821 CFR 1250.33(b)1Cleaning of all other utensilsFailure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] utensils (other than multiuse utensils) following the day's operation. Specifically, ***
657321 CFR 1250.341Backflow protection for waste water drainsWaste water drains from [ice boxes] [refrigerating equipment] [refrigerated spaces] are not so installed as to prevent backflow of contaminating liquids. Specifically, ***
658421 CFR 1250.391Containers - watertight, readily cleanable, non-absorbentGarbage containers are not [watertight] [readily cleanable] [non-absorbent]. Specifically, ***
658821 CFR 1250.411Submittal of construction plansFailure to submit plans for the [construction] [major reconstruction] of [sanitary equipment] [facilities] to FDA for review. Specifically, ***
659021 CFR 1250.42(a)1Complete and closedA water system which is not [complete] [closed] from the filling ends to the discharge taps (except for protected vent openings). Specifically, ***
659621 CFR 1250.42(d)1Water filtersFailure to [operate] [maintain] water filters so as to prevent contamination of the water. Specifically, ***
661221 CFR 1250.501Designed to permit ready cleaningLack of design of [toilet] [lavatory] facilities so as to permit ready cleaning. Specifically, ***
703821 CFR 1250.671Signs for non-potable waterOutlets for non-potable water are not posted with [permanent] signs warning that the water is unfit for drinking. Specifically, ***
705421 CFR 1250.75(b)1Soil cans and removable containersFailure to [thoroughly] clean [soil cans] [removable containers] prior to return to use. Specifically, ***
705821 CFR 1250.79(a)1Container constructionContainers used to [receive] [store] garbage are not [water-tight] [readily cleanable] [nonabsorbent] [equipped with close-fitting covers]. Specifically, ***
712121 CFR 1250.961Rodent infestationFailure to prevent, through generally accepted methods of control, an infestation by rodents.Specifically, ***

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Human tissue for transplantation

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Human tissue for transplantation1222121 CFR 1271.47(a)18Procedures for all stepsProcedures 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, ***
1233621 CFR 1271.180(a)16Procedures to meet core CTGPProcedures 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, ***
1231121 CFR 1271.160(b)(1)10Ensuring appropriate core requirements followedThe quality program has not ensured that appropriate procedures related to core CGTP requirements were [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [approved] [revised]. Specifically, ***
1227721 CFR 1271.75(a)(1)9Risk factors, clinical evidenceDonors were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of communicable disease agents and diseases.  Specifically, ***
1232621 CFR 1271.160(c)9Quality audits performed periodicallyPeriodic quality audits of activities related to core CGTP requirements have not been performed. Specifically, ***
1236921 CFR 1271.200(b)9Procedures inadequateProcedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, ***
1241121 CFR 1271.260(a)8Contamination, mix ups, improper releaseStorage 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, ***
1243721 CFR 1271.270(a)8Records incompleteRecords [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, ***
1502021 CFR 1271.200(e)8Documentation of maintenance and cleaningDocumentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained. Specifically, ***
1228321 CFR 1271.75(e)6Abbreviated procedureThe 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, ***
1228721 CFR 1271.80(c)6Kits not FDA approved, specifically labeledCommunicable disease agent tests [were not FDA-licensed, approved or cleared donor screening tests] [were not specifically labeled for cadaveric specimens when such a test was available and cadaveric specimens were used].   Specifically, ***
1231021 CFR 1271.160(a)6All core requirements covered in programA 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, ***
1232221 CFR 1271.160(b)(4)6Training of personnelThe quality program has not ensured the proper training and education of personnel involved in core GTP activities.  Specifically, ***
1232421 CFR 1271.160(b)(6)6Deviations--Investigation, documenting, trendingThe quality program does not include [the investigation] [the documentation] [the trending] [the reporting] of HCT/P deviations relating to core CTGP requirements. Specifically, ***
1233421 CFR 1271.170(c)6Trained or re-trained as necessaryPersonnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities.  Specifically, ***
1241621 CFR 1271.260(e)6Storage temperatures recorded, maintainedStorage temperatures of HCT/Ps were not [recorded] [maintained].   Specifically, ***
1243121 CFR 1271.265(e)6Procedures and release criteriaProcedures including release criteria for activities relating to  the [receipt] [shipment] [distribution] of HCT/Ps were not [established] [maintained] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
1243521 CFR 1271.270(a)6Records maintained concurrentlyRecords were not maintained concurrently with the performance of each step. Specifically, ***
1243621 CFR 1271.270(a)6Accurate, indelible, legibleRecords were not [accurate] [indelible] [legible].  Specifically, ***
1228621 CFR 1271.80(b)5Specimen collections not   timelyDonor specimens used for testing of communicable disease agents were not collected at the appropriate time.  Specifically, ***
1230121 CFR 1271.150(c)(1)(iii)5Ensurane of complianceYou 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, ***
1232321 CFR 1271.160(b)(5)5Monitoring systemsThe quality program has not established and maintained appropriate monitoring systems. Specifically, ***
1236321 CFR 1271.195(c)5Monitoring--cross contamination, exposure to CDEnvironmental conditions are not monitored when such conditions could cause [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease agents].   Specifically, ***
1238121 CFR 1271.210(d)(2)5Verification elementsDocumentation of the verification of [supplies] [reagents] did not include [test results] [a certificate of analysis from the vendor].   Specifically, ***
373621 CFR 1270.31(b)4Assessment of relevant medical recordsFailure to [prepare] [follow] written procedures for all significant steps for [obtaining] [reviewing] [assessing] the relevant medical records of a donor. Specifically, ***
1221321 CFR 1271.47(a)4Donor eligibility proceduresProcedures 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, ***
1223721 CFR 1271.55(a)(3)4Summary--records used to make determinationAfter 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, ***
1223821 CFR 1271.55(b)(1)4Statement re: certified testing labThe 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, ***
1233221 CFR 1271.170(b)4Qualifications lackingPersonnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions.   Specifically, ***
1236521 CFR 1271.195(d)4Documentation not maintainedDocumentation of environmental control and monitoring activities was not maintained. Specifically, ***
1237221 CFR 1271.200(c)4Calibrated per established schedulesEquipment used for [inspection] [measuring] [testing] was not calibrated according to established schedules. Specifically, ***
1237521 CFR 1271.210(a)4Use prior to verificationSupplies and reagents were used before they were verified to meet specifications designed to prevent the introduction, transmission, or spread of communicable disease. Specifically, ***
1241721 CFR 1271.260(e)4Periodic review of temperaturesRecorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.   Specifically, ***
1242821 CFR 1271.265(c)(3)4Departures:  recorded and justifiedDepartures from procedures were not [recorded] [justified] at the time of occurrence. Specifically, ***
1244721 CFR 1271.290(b)4Establishing a systemA 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, ****
1245321 CFR 1271.290(e)4Documenting disposition of each HCT/PA method has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] in the tracking system [to document the disposition of each HCT/P] [to permit the prompt identification of the consignee of the HCT/P, if any].  Specifically, ***
1222321 CFR 1271.47(b)3Review and approval of proceduresDonor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation.  Specifically, ***
1222421 CFR 1271.47(c)3Availability of proceduresDonor eligibility procedures were not available to personnel in the area where operations are performed, or in a nearby area when such availability is impractical. Specifically, ***
1222921 CFR 1271.50(a)3Determination based on screening and testingHCT/P donors were not determined to be eligible based on the results of donor screening and testing.  Specifically, ***
1223021 CFR 1271.50(a)3Responsible person to determine, documentThe eligibility of an HCT/P donor was not [determined] [documented] by a responsible person, based on results of donor screening and donor testing.   Specifically, ***
1228821 CFR 1271.80(c)3Manufacturer instructions not followedTesting for communicable disease agents was not performed in accordance with the manufacturer's instructions.  Specifically, ***
1230921 CFR 1271.160(a)3Program is appropriate for the HCT/PsA quality program appropriate for the  HCT/Ps manufactured and manufacturing steps performed has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
1231921 CFR 1271.160(b)(3)3Actions taken and documentedThe quality program has not ensured that appropriate corrective actions relating to core CGTP requirements are [taken] [documented].   Specifically, ***
1232021 CFR 1271.160(b)(3)3Actions verified, short and long term solutionsCorrective actions relating to core CGTP requirements [have not been verified to ensure effectiveness and compliance with CGTP] [did not include both short term corrective actions to address the immediate deficiency and long term corrective actions to prevent recurrence].  Specifically, ***
1232521 CFR 1271.160(b)(6)3Deviations--evaluation, cause, corrective actionInvestigation 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, ***
1234321 CFR 1271.190(a)3State of repairFacilities were not maintained in a good state of repair.   Specifically, ***
1235121 CFR 1271.190(d)(1)3Procedures for cleaning, sanitationProcedures for facility cleaning and sanitation were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, ***
1235421 CFR 1271.190(d)(2)3Documentation of activitiesDocumentation of facility cleaning and sanitation activities was not maintained. Specifically, ***
1237121 CFR 1271.200(a)3Cleaned, sanitized per established schedulesEquipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained] according to established schedules. Specifically, ***
1237721 CFR 1271.210(c)3In-house reagent productionThe processes used for the production of in-house reagents were not [validated] [verified]. Specifically, ***
1238221 CFR 1271.210(d)(3)3Lot documentation maintainedDocumentation of the lot of [supplies] [reagents] used in the manufacture of each HCT/P was not maintained.  Specifically, ***
1238921 CFR 1271.220(c)3Specified requirements for in-process controlsSpecified requirements for in-process controls were not met.   Specifically, ***
1240821 CFR 1271.250(c)3All labeling requirements metLabeling procedures did not ensure that HCT/Ps are labeled in accordance with all labeling requirements.  Specifically, ***
1242121 CFR 1271.265(a)3Acceptance criteria designed to prevent CDIncoming HCT/Ps were not [accepted] [rejected] [placed in quarantine] based on pre-established criteria designed to prevent communicable disease transmission. Specifically, ***
1249421 CFR 1271.85(c)3Reproductive cells or tissuesDonors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not tested for communicable diseases of the genitourinary tract.  Specifically, ***
372421 CFR 1270.21(f)2Donor identity, relevant recordsThe determination by a responsible person that the human tissue was suitable for transplantation did not include [donor identity] [relevant medical records as defined in 21 CFR 1270.3(t)].  Specifically, ***
1222221 CFR 1271.47(a)2Design of procedures to ensure complianceProcedures were not designed to ensure compliance with the donor eligibility requirements. Specifically, ***
1222521 CFR 1271.47(d)2Departures: recording and justifyingDepartures from donor eligibility procedures relevant to preventing risks of communicable disease transmission were not [recorded] [justified].   Specifically, ***
1224021 CFR 1271.55(b)(3)2Name and address on summaryThe summary of records for HCT/Ps did not contain the [name] [address] of the establishment that made the donor-eligibility determination.   Specifically, ***
1228121 CFR 1271.75(c)2Reproductive cells/tissues-Chlamydia, NeisseriaDonors 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 [Chlamydia trachomatis] [Neisseria gonorrhea].  Specifically, ***
1229021 CFR 1271.80(d)(1)2Reactive tests--not determined ineligibleDonors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible.   Specifically, ***
1231421 CFR 1217.160(b)(2)(iii)2Risk assessment, quarantine, recall, FDAThe quality program has not ensured that procedures include provisions for [assessing the risk of] [quarantine of] [recall of] [reporting to FDA on] HCT/Ps that have been made available for distribution and for which there is information related to the possible contamination or communicable disease transmission. Specifically, ***
1231521 CFR 1271.160(b)(2)2Sharing 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, ***
1231621 CFR 1271.160(b)(2)(i)2Other establishments - same donor involvedThe quality program has not ensured that procedures exist for sharing information pertaining to the possible contamination of the HCT/P, or the potential for transmission of a communicable disease by the HCT/P, with other establishments that are known to have recovered HCT/Ps from the same donor.   Specifically, ***
1232821 CFR 1271.160(d)2Validation for intended useThe performance of [custom computer software] [commercial computer software that has been customized or programmed], including changes to computer software, has not been validated for the intended use, when such software is relied upon to comply with core GTP requirements.  Specifically, ***
1233121 CFR 1271.170(a)2Sufficient numberPersonnel are not sufficient to ensure compliance with the requirements. Specifically, ***
1233721 CFR 1271.180(a)2Design adequate to bar spread of CD'sProcedures were not designed to prevent circumstances that increase the risk of communicable disease introduction, transmission and spread through the use of HCT/Ps. Specifically, ***
1233821 CFR 1271.180(b)2Review and approval-responsible personProcedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation.  Specifically, ***
1233921 CFR 1271.180(c)2Availability of proceduresProcedures for core CTGP requirements were not available to personnel   in the area where operations are performed, or in a nearby area when such availability is impractical.  Specifically, ***
1235621 CFR 1271.195(a)2Adequate control, proper conditionsEnvironmental 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, ***
1235821 CFR 1271.195(a)(2)2Ventilation and air filtration controlsEnvironmental controls do not provide for adequate [ventilation] [air filtration]. Specifically, ***
1235921 CFR 1271.195(a)(3)2Aseptic processing---cleaning, disinfectingEnvironmental controls do not provide for adequate [cleaning] [disinfecting] of [rooms] [equipment] to ensure aseptic processing.   Specifically, ***
1239821 CFR 1271.230(a)2Validation & approval--established proceduresProcesses with results which could not be fully verified by inspection and tests, were not validated and approved according to established procedures. Specifically, ***
1239921 CFR 1271.230(a)2Process validation proceduresProcedures 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, ***
1241421 CFR 1271.260(d)2Corrective actionsCorrective actions were not [performed] [documented] when proper storage conditions were not met. Specifically, ***
1241521 CFR 1271.260(e)2Temperature limitsAcceptable 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, ***
1242321 CFR 1271.265(b)2Shipment in quarantine of HCT/PsHCT/Ps shipped as pre-distribution shipments [within your establishment] [between establishments] which do not meet the criteria for being available for distribution were not shipped in quarantine.   Specifically, ***
1242921 CFR 1271.265(d)2Shipping conditions appropriateAppropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P. Specifically, ***
1243321 CFR 1271.265(f)2Return to inventory--proceduresProcedures 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, ***
1243821 CFR 1271.270(b)2Management system re: core CGTPsA records management system relating to core CGTP requirements was not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
1247921 CFR 1271.370(b)(4)2Warnings on labelHCT/Ps made available for distribution were not labeled with or accompanied by applicable warnings.  Specifically, ***
1249221 CFR 1271.85(a)2Infection with communicable disease agentsDonors were not tested for evidence of infection with communicable disease agents. Specifically, ***
1249321 CFR 1271.90(b)2Eligibility not required--warning labelsHCT/Ps for which the donor eligibility determination was not performed were not prominently labeled with the appropriate warning statements.   Specifically, ***
372221 CFR 1270.21(e)1Accompanying donor recordsHuman tissue intended for transplantation was not accompanied by a summary or copies of the donor's relevant medical records as defined in 21 CFR 1270.3(t). Specifically, ***
372321 CFR 1270.21(e)1Person responsibleThe summary or copies of the donor's relevant medical records as defined in 21 CFR 1270.3(t) failed to designate and identify the person responsible for making the determination that the human tissue was suitable for transplantation. Specifically, ***
374021 CFR 1270.31(d)1Prevention of cross-contaminationFailure to [prepare] [validate] [follow] written procedures for prevention of [infectious disease contamination] [cross-contamination] during processing. Specifically, ***
374421 CFR 1270.33(a)1Accurate, indelible, legibleFailure to maintain records which are [accurate] [indelible] [legible].   Specifically, ***
374521 CFR 1270.33(a)1Person involved, dates, detailsRecords fail to [identify the person performing the work] [include the dates of the various entries] [be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved]. Specifically, ***
374921 CFR 1270.33(d)1Determination of suitabilityFailure to accompany tissue which has been determined to be suitable for transplantation with a summary or copy of original records documenting that the tissue has been so determined.  Specifically, ***
375021 CFR 1270.33(d)1Completion and review of testing & screeningFailure to accompany tissue which has been determined to be suitable for transplantation with a summary or copy of original records documenting that all infectious testing and screening have been [completed] [reviewed] [found to be negative]. Specifically, ***
375121 CFR 1270.33(e)1Quarantine until release or dispositionFailure to quarantine tissue until [it has been determined to be suitable for transplantation] [appropriate disposition has been accomplished]. Specifically, ***
375221 CFR 1270.33(f)1Make available to FDAFailure to make available for inspection or upon request by FDA, records regarding donor suitability, including all testing and screening records.   Specifically, ***
375421 CFR 1270.33(h)1Retention for 10 yearsFailure to retain records regarding donor suitability for at least 10 years beyond the date of transplantation if known, distribution, disposition, or expiration of the tissue, whichever is latest.   Specifically, ***
375821 CFR 1270.35(c)1Receipt and/or distributionRecords fail to include documentation of receipt and/or distribution of human tissue. Specifically, ***
1222621 CFR 1271.47(d)1Determining risks when departures involvedA determination that departures from donor eligibility procedures did not increase the risk of communicable disease transmission was not made by a responsible person prior to making an HCT/P available for distribution. Specifically, ***
1222721 CFR 1271.47(e)1Adopting procedures from another organizationCurrent donor eligibility procedures adopted from another organization were not verified to be [consistent with the donor eligibility requirements specified in the regulations] [appropriate for your operations]. Specifically, ***
1223621 CFR 1271.55(a)(2)1Eligibility statement--basis of determinationAfter the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing.   Specifically, ***
1223921 CFR 1271.55(b)(2)1Listing and interpretation of CD tests performedThe summary of records for HCT/Ps did not contain [a listing] [an interpretation of results] of all communicable disease tests performed.   Specifically, ***
1224221 CFR 1271.55(c)1Name and personal info on accompanying recordsThe accompanying records for HCT/Ps included [the donor's name] [personal information that might identify the donor].  Specifically, ***
1224521 CFR 1271.55(d)(1)(ii)1Results, interpretation of CD screeningDocumentation of [the results] [the interpretation] of all donor screening for communicable diseases was not maintained.   Specifically, *
1224621 CFR 1271.55(d)(1)(iii)1Documentation--determination, by whom, dateDocumentation 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, ***
1224921 CFR 1271.55(d)(3)1Records not made available to FDARequired donor eligibility records were not made available for authorized inspection or upon request by FDA.  Specifically, ***
1225421 CFR 1271.60(b)1Identified as quarantined, distinguishableHCT/Ps in quarantine pending completion of the donor eligibility determination were [not clearly identified as quarantined] [not easily distinguishable from HCT/Ps available for release and distribution]. Specifically, ***
1225821 CFR 1271.60(c)(3)1Statement of restrictionsHCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not accompanied by records that stated the product must not be implanted, transplanted, infused or transferred until completion of the donor-eligibility determination.   Specifically, ***
1226421 CFR 1271.60(d)(2)(ii)1Results of completed donor testingHCT/Ps made available for use in cases of urgent medical need were not accompanied by the results of any donor testing that has been completed.   Specifically, ***
1226721 CFR 1271.60(d)(4)1Eligibility determination not completedThe donor-eligibility determination was not completed for HCT/Ps used in cases of urgent medical need.  Specifically, ***
1227521 CFR 1271.65(c)1Nonclinical use--label requirementsHCT/Ps from ineligible donors which were made available for nonclinical use were not labeled ["For Nonclinical Use Only"] [with the Biohazard legend]. Specifically, ***
1227821 CFR 1271.75(a)(2)1Risks associated with xenotransplantationDonors were not screened by a review of relevant medical records for disease risks associated with xenotransplantation.  Specifically, ***
1231221 CFR 1271.160(b)(2)1Procedures for complaints and other informationThe quality program has not ensured that procedures exist for [receiving] [investigating] [evaluating] [documenting] information relating to core CGTP requirements, including complaints.
1232121 CFR 1271.160(b)(3)1Problem 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, ***
1232921 CFR 1271.160(d)1Documentation/approval prior to implementationComputer software [validation] [verification] activities and results have not been [documented] [approved] prior to implementation.   Specifically, ***
1233321 CFR 1271.170(b)1Not qualified, authorized for functionsPersonnel perform functions for which they are not [qualified] [authorized]. Specifically, ***
1234021 CFR 1271.180(d)1Adopted from another organizationCurrent 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, ***
1234221 CFR 1271.190(a)1Size, 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, ***
1234521 CFR 1271.190(b)(1)1Clean, sanitary, orderly mannerFacilities were not maintained in a [clean] [sanitary] [orderly] manner to prevent the introduction, transmission, or spread of communicable disease. Specifically, ***
1234921 CFR 1271.190(c)1Control systemOperations were not controlled with a system [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] to prevent [improper labeling] [mix-ups] [contamination] [cross contamination] [accidental exposure of HCT/Ps to communicable disease agents].   Specifically, ***
1236221 CFR 1271.195(b)1Corrective actionsAppropriate corrective actions were not taken related to the inspections of environmental control systems.  Specifically, ***
1236721 CFR 1271.200(a)1Design appropriate, suitably locatedEquipment used in the manufacture of HCT/Ps was [not of appropriate design for its use] [not suitably located to facilitate operations, cleaning and maintenance]. Specifically, ***
1237021 CFR 1271.200(c)1Calibration 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, ***
1237321 CFR 1271.200(d)1Inspected routinelyEquipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to maintenance schedules].  Specifically, ***
1237821 CFR 1271.210(d)(1)1Receipt documentation maintainedDocumentation of the receipt of [supplies] [reagents] was not maintained. Specifically, ***
1237921 CFR 1271.210(d)(1)1Receipt documentation elementsThe documentation for the receipt of [supplies] [reagents] did not include [the type] [the quantity] [the manufacturer] [the lot number] [the date of receipt] [the expiration date].  Specifically, ***
1238021 CFR 1271.210(d)(2)1Verification documentation maintainedDocumentation of the verification of [supplies] [reagents] was not maintained. Specifically, ***
1238421 CFR 1271.2151Potential problems with recoveryHCT/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, ***
1239621 CFR 1271.2251Approval and timely communicationProcess changes were [not approved by a responsible person with appropriate knowledge and background prior to implementation] [not communicated to personnel in a timely manner].  Specifically, ***
1240021 CFR 1271.230(a)1Documented, dated, signedThe validation [activities] [results] were not [documented] [dated and signed by the individual(s) approving the validation].   Specifically, ***
1240121 CFR 1271.230(b)1Reduced risk representationWritten 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, ***
1240721 CFR 1271.250(b)1Verification of label accuracy, legibility, integrityLabeling procedures did not include verification of label [accuracy] [legibility] [integrity]. Specifically, ***
1240921 CFR 1271.250(c)1Documentation of donor eligibilityLabeling procedures did not ensure that HCT/Ps made available for distribution are accompanied by documentation of the donor eligibility determination. Specifically, ***
1241221 CFR 1271.260(b)1Storage temperatures appropriateHCT/Ps were not stored at appropriate temperatures.   Specifically, ***
1241321 CFR 1271.260(c)1Expiration date factorsHCT/Ps were not assigned an expiration date based on [type of HCT/P] [processing, including method of preservation] [storage conditions] [packaging]. Specifically, ***
1241921 CFR 1271.265(a)1Evaluation--microorganisms, damageIncoming HCT/Ps were [not evaluated for the presence and significance of microorganisms] [not inspected for damage and contamination].   Specifically, ***
1242521 CFR 1271.265(c)(1)1Release of HCT/Ps by responsible personA responsible person did not [document] [date] the determination that an HCT/P is available for distribution. Specifically, ***
1242721 CFR 1271.265(c)(3)1HCT/Ps made under departure from processA responsible person did not determine that HCT/Ps manufactured under a departure from procedures do not increase the risk of communicable disease prior to making the HCT/Ps available for distribution.   Specifically, ***
1243221 CFR 1271.265(e)1Documentation elements for activitiesDocumentation 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, ***
1244321 CFR 1271.270(d)1Retention time (10 year rules)Records were not retained for the appropriate length of time,   [10 years after their creation] [at least 10 years after the date of administration of a particular HCT/P] [at least 10 years after the date of a particular HCT/Ps distribution, disposition, or expiration, whichever is latest, when the date of administration is not known] [10 years after the appropriate disposition of archived specimens of dura mater]. Specifically, ***
1245721 CFR 1271.320(a)1Procedures re complaintsProcedures for the [review] [evaluation] [documentation] [investigation] of complaints relating to core CGTP requirements were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
1246321 CFR 1271.320(c)1Documentation of decision not to investigateWhen no investigation of a complaint was made for an event that is not required to be reported to FDA, a record of [the reason no investigation was made] [the individual responsible for making that decision] was not maintained.   Specifically, ***
1247021 CFR 1271.350(a)(2)115 day reporting timeframeAdverse reactions were not reported to FDA using form FDA 3500A within 15 calendar days of initial receipt of information.  Specifically, ***
1247221 CFR 1271.350(b)(1)1Deviations not investigatedHCT/P deviations related to distributed HCT/Ps for which the establishment performed a manufacturing step were not investigated.  Specifically, ***
1247321 CFR 1271.350(b)(2)1Deviations not reported to FDAHCT/P deviations relating to core CGTP requirements that occurred [in your establishment] [at an establishment under contract, agreement, or arrangement with your establishment] were not reported to FDA.   Specifically, ***
1248921 CFR 1271.90(b)(1)1Autologous use only--labelingHCT/Ps for autologous use and for which the donor eligibility determination was not performed were not labeled for autologous use only.   Specifically, ***
1249621 CFR 1271.85(b)(2)1SOP for release; reactive for CMVA 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. ***
1502321 CFR 1271.270(b)1Management system, other recordsRecords pertinent to the manufacture of HCT/Ps were not maintained and organized under the records management system.  Specifically, ***
1502521 CFR 1271.85(b)(2)1Cytomegalovirus (CMV)Donors of viable, leukocyte-rich cells or tissue were not tested for evidence of infection due to cytomegalovirus (CMV).   Specifically, ***

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Radiological health

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Radiological health500721 CFR 1002.132Failure to submitYou did not submit an annual report [by the September 1 deadline] for products requiring one. Specifically, ***
503221 CFR 1010.2(b)1Certification label or tagA 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, ***
570021 CFR 1002.101Failure to submit, distinct markingYou 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, ***

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