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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FY 2012 Inspectional Observation Summaries

 

Number of 483s issued from the System* 

Inspections ending between 10/1/2011 12:00:00 AM and 9/30/2012 12:00:00 AM

Center Name483s issued
Foods3057
Devices1090
Drugs787
Incidental text421
Bioresearch monitoring283
Veterinary medicine243
Biologics237
Parts 1240 and 1250110
Human tissue for transplantation138
Radiological health18
Special requirements22
Sum Product Area 483s from System*6406
Actual Total in system 483s**5797

* This table does not represent the complete set of 483's issued during the fiscal year as some 483's were manually prepared and not available in this format. The sum of 483's for all Product Areas will be greater than the actual Total 483's issued during the fiscal year since a 483 may include citations related to multiple product areas, and counted more than once, under each relevant product center.

** This is the Actual Total number of 483's issued from this system, and that are represented in this spreadsheet.

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Foods

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Foods156021 CFR 110.35(c)422Lack 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, ***
152421 CFR 123.11(b)350Sanitation 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, ***
130621 CFR 110.20(b)(7)322ScreeningFailure to provide adequate screening or other protection against pests. Specifically, ***
90521 CFR 123.6(b)244HACCP plan implementationYou did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan. Specifically, ***
142221 CFR 110.20(b)(4)237Floors, 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)235Buildings/sanitaryFailure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, ***
96121 CFR 123.6(c)(3)202Critical 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,
600421 CFR 123.6(c)(4)199Monitoring - adequacyYour HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit. Specifically***
96021 CFR 123.6(c)(2)198Critical 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, ***
169521 CFR 110.80(b)(2)194Manufacturing conditionsFailure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination]. Specifically, ***
90421 CFR 123.6(b)187No HACCP planYou do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur. Specifically, ***
95921 CFR 123.6(c)(1)178Food safety hazardsYour HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, ***
155321 CFR 110.35(a)178Buildings/good repairFailure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated. Specifically, ***
170121 CFR 110.80(b)(7)178Equipment, containers, utensilsFailure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold] [store] food in a manner that protects against contamination. Specifically, ***
152521 CFR 123.11(c)173Sanitation 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, ***
128721 CFR 110.20(a)(1)170Harborage 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, ***
168921 CFR 110.80169Reasonable precautionsAll reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, ***
155421 CFR 110.35(a)166Cleaning 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, ***
96321 CFR 123.6(c)(5)163Corrective 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***
99021 CFR 110.10(b)(3)155Not 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, ***
140521 CFR 110.10(b)(6)148Failure to wearFailure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate. Specifically, ***
238621 CFR 110.80(a)(1)145StorageFailure to store raw materials in a manner that [protects against contamination] [minimizes deterioration]. Specifically, ***
156221 CFR 110.35(d)130Failure to clean - generalFailure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food. Specifically, ***
142721 CFR 110.20(b)(5)129Safety lighting and glassFailure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food. Specifically, ***
158121 CFR 110.37(e)122Running water at suitable temperatureHand-washing facilities lack running water of a suitable temperature. Specifically, ***
159721 CFR 110.37(b)(3)121As source of contaminationPlumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils]. Specifically, ***
142421 CFR 110.20(b)(4)119Drip 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, ***
600821 CFR 123.8(a)(3)115Verification - 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, ***
600521 CFR 123.6(c)(6)113Verification 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, ***
94521 CFR 123.12(a)(2)112Importer 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, ***
112521 CFR 110.40(a)112Materials and workmanshipThe [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance]. Specifically, ***
90821 CFR 123.6(d)110Signed and datedYour HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually]. Specifically, ***
129221 CFR 110.20(b)(1)108Sufficient 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, ***
366121 CFR 110.37(e)(5)101SignsLack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate. Specifically, ***
239221 CFR 110.80(b)(1)100Maintenance of equip., utensils, and finished food packagingFailure to maintain [equipment] [utensils] [finished food containers] in an acceptable condition through appropriate cleaning and sanitizing. Specifically, ***
602021 CFR 123.9(a)100Records - 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, ***
155621 CFR 110.35(b)(2)93Storage 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, ***
169821 CFR 110.80(b)(5)93Work-in-progressFailure to handle work-in-progress in a manner that protects against contamination. Specifically, ***
602121 CFR 123.1086HACCP training or qualificationNo one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience. Specifically, ***
100721 CFR 110.10(b)(9)85Precautions 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, ***
100521 CFR 110.10(b)(7)84Storage of personal itemsPersonal [clothing] [belongings] were stored in an area where [food is exposed] [equipment or utensils are washed]. Specifically, ***
159921 CFR 110.37(b)(5)84Backflow preventionLack of backflow protection from piping systems that discharge [waste water] [sewage]. Specifically, ***
365221 CFR 110.37(e)(1)83Suitable locationsFailure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed. Specifically, ***
161521 CFR 110.9380Storage/transportation of finished goods (contamination)Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination. Specifically, ***
93321 CFR 123.8(a)(2)(ii)76Calibration - adequacyYour process monitoring equipment is not calibrated to ensure that it reads accurately. Specifically, ***
106621 CFR 110.40(b)76Seams 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, ***
100621 CFR 110.10(b)(8)73Personal 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, ***
112621 CFR 110.40(a)72Precluding contaminantsThe [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food with [lubricants] [fuel] [metal fragments] [contaminated water] [contaminants]. Specifically, ***
365821 CFR 110.37(e)(2)72Hand cleaning and sanitizing preparationsLack of effective hand [cleaning] [sanitizing] preparations. Specifically, ***
117321 CFR 110.40(f)69Q.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,***
601821 CFR 123.7(a)67Corrective 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,***
1585821 CFR 111.75(a)(1)(i)67Component - verify identity, dietary ingredientYou did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use. Specifically, ***
365921 CFR 110.37(e)(3)66Hand dryingLack of a sanitary towel service or suitable hand drying devices. Specifically, ***
140221 CFR 110.10(b)(4)65Unsecured jewelryEmployees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers]. Specifically, ***
600121 CFR 123.11(b)65Sanitation monitoring documentationYour sanitation control records do not accurately document the conditions or practices observed at your firm. Specifically, ***
1272021 CFR 1.22565Not registeredYour food facility is not registered as required. Specifically, ***
90121 CFR 123.6(a)61Hazard 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, ***
157121 CFR 110.35(d)(5)61Shown to be effectiveThe [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not been shown to provide adequate [cleaning] [sanitizing treatment]. Specifically, ***
98521 CFR 110.10(b)(1)59Suitable outer garmentsSuitable outer garments are not worn that protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, ***
142921 CFR 110.20(b)(6)59Fans/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, ***
447021 CFR 108.25(c)(2)57Process filingFailure to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container size. Specifically, ***
1583921 CFR 111.70(e)57Specifications - identity, purity, strength, compositionYou did not establish product specifications for the [identity] [purity] [strength] [composition] of the finished dietary supplement. Specifically, ***
140621 CFR 110.10(b)(6)56Effective use of hair restraintFailure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner. Specifically, ***
117221 CFR 110.40(e)51Lack 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, ***
364321 CFR 110.10(b)(5)50Glove conditionGloves used in food handling are not maintained in an intact, clean, and sanitary condition. Specifically, ***
1586921 CFR 111.75(c)49Specifications met - verify; finished batchYou did not verify that your finished batch of dietary supplement meets product specifications for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement]. Specifically, ***
90621 CFR 123.6(b)45HACCP plan locationYour HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery product processed]. Specifically, ***
156521 CFR 110.35(d)(3)45Non-food-contact surfaces (S)Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination. Specifically, ***
601521 CFR 123.6(c)(6)45Verification 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, ***
170221 CFR 110.80(b)(8)44Metal / extraneous materialsFailure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food. Specifically, ***
157821 CFR 110.37(f)43Odor, 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, ***
993121 CFR 120.6(b)43Sanitation 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, ***
1586121 CFR 111.75(a)(2)(ii)(A)43Component - qualify supplierYou did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations. Specifically, ***
1579721 CFR 111.55342Written procedures - product complaintYou did not [establish] [follow] written procedures for the requirements to review and investigate a product complaint. Specifically, ***
142621 CFR 110.20(b)(5)41Adequate 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, ***
1592721 CFR 111.10341Written procedures - quality control operationsYou did not [establish] [follow] written procedures for quality control operations. Specifically, ***
159821 CFR 110.37(b)(4)40DrainagePlumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage. Specifically, ***
1576221 CFR 111.205(a)40Master manufacturing record - each batchYou did not [prepare] [follow] a written master manufacturing record for each batch size of a dietary supplement that you manufactured. Specifically, ***
129321 CFR 110.20(b)(2)39Contamination 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, ***
1553221 CFR 111.255(b)38Batch record - completeYour batch production record did not include complete information relating to the production and control of each batch. Specifically, ***
601621 CFR 123.6(c)(7)37Records systemYour HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points. Specifically, ***
1576321 CFR 111.205(a)37Master manufacturing record - unique formulationYou did not [prepare] [follow] a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured. Specifically, ***
106721 CFR 110.40(c)36Non 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, ***
307821 CFR 114.80(b)34Code - 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, ***
1565921 CFR 111.475(b)(1)32Written procedures - holding; distributingYou did not make and keep written procedures for holding and distributing operations. Specifically, ***
157021 CFR 110.35(d)(5)31Safe and adequate for useSanitizing agents are [inadequate] [unsafe] under conditions of use. Specifically, ***
169621 CFR 110.80(b)(3)31Holding 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, ***
170921 CFR 110.80(b)(13)31Filling, assembling, packing controlsFailure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated. Specifically, ***
365621 CFR 110.37(d)(3)31Self-closing doorsToilet facilities lack self-closing doors. Specifically, ***
176321 CFR 110.35(b)(1)30Safe 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, ***
365421 CFR 110.37(d)(1)30MaintainedFailure to maintain toilet facilities in a sanitary condition. Specifically, ***
601021 CFR 123.8(a)(3)(i)30Monitoring 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, ***
1583021 CFR 111.70(b)(2)30Specifications-component purity, strength, compositionYou did not establish component specifications for [purity] [strength] [composition]. Specifically, ***
236121 CFR 110.8029TestingFailure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, ***
308021 CFR 114.8329Scheduled 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, ***
1564121 CFR 111.45329Written procedures - holdingYou did not [establish] [follow written] procedures for holding and distributing operations. Specifically, ***
1580921 CFR 111.570(b)(1)29Written procedures - product complaint; review, investigateYou did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint. Specifically, ***
1589721 CFR 111.83(a)29Reserve sample - collect, holdYou did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed. Specifically, ***
128921 CFR 110.20(a)(3)28DrainageLack of adequate drainage of areas which may contribute to contamination of food by [seepage] [foot-borne filth] [providing a breeding place for pests]. Specifically, ***
1553121 CFR 111.255(a)28Batch record - every batchYou did not prepare a batch production record every time you manufactured a batch of dietary supplement. Specifically, ***
1607021 CFR 111.35(b)(2)28Document-equipment date of use, maintain, clean, sanitizeYou did not make and keep documentation of [the date of the use] [maintenance] [cleaning] [sanitizing] of the equipment. Specifically, ***
112821 CFR 110.40(a)27Installation and maintenance of equipment (S)Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces]. Specifically, ***
113221 CFR 110.40(a)27Food-contact - unlawful indirect additivesFailure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives. Specifically, ***
159621 CFR 110.37(b)(2)27Convey sewagePlumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey sewage and liquid disposable waste from the plant. Specifically, ***
160221 CFR 110.37(a)27Suitable 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, ***
365521 CFR 110.37(d)(2)27Good repairFailure to keep toilet facilities in good repair. Specifically, ***
1582921 CFR 111.70(b)(1)27Specifications - component identityYou did not establish an identity specification for each component. Specifically, ***
1604221 CFR 111.50327Written procedures - returned dietary supplementYou did not [establish] [follow] written procedures for when a returned dietary supplement is received. Specifically, ***
113021 CFR 110.40(a)26Food-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, ***
156121 CFR 110.35(c)26Insecticides/rodenticidesUse of [insecticides] [rodenticides] without observing necessary precautions and restrictions to protect against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
364721 CFR 110.10(c)26Training of handlers and supervisorsAppropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors]. Specifically, ***
1605721 CFR 111.535(b)(1)26Records - returned dietary supplement: written proceduresYou did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements. Specifically, ***
1274221 CFR 120.8(a)25HACCP plan not implementedYou did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan. Specifically, ***
1579621 CFR 111.430(b)25Records - packaging, labeling operationsYou did not make and keep records of the written procedures for [packaging] [labeling] operations. Specifically, ***
140321 CFR 110.10(b)(4)24Hand jewelry - remove/coverFailure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods where food is being manipulated by hand. Specifically, ***
118421 CFR 110.35(e)23Storage 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, ***
307121 CFR 114.80(a)(1)23Scheduled processAcidified food is not manufactured in accordance with the scheduled process. Specifically, ***
600621 CFR 123.6(c)(7)23Records values/observationsYour monitoring records do not contain the actual values and observations obtained during monitoring. Specifically, ***
601921 CFR 123.8(a)(2)23Ongoing 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, ***
93121 CFR 123.8(d)22Verification - recordkeepingYou do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing]. Specifically, ***
238421 CFR 110.80(a)(7)22Receipt/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, ***
109021 CFR 110.40(d)21Holding, conveying, mfg systems - design & constructionLack of appropriate [design] [construction] to enable [holding] [conveying] [manufacturing] systems to be maintained in an appropriate sanitary condition. Specifically, ***
169721 CFR 110.80(b)(4)21Preventive 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, ***
239321 CFR 110.80(b)(1)21Teardown equipment/thorough cleaningFailure to take apart equipment as necessary to ensure thorough cleaning. Specifically, ***
600721 CFR 123.9(a)21Records entries - timingProcessing or other information was not [always] entered on your records at the time it was observed. Specifically, ***
995521 CFR 120.11(a)(1)21Verification activities - minimumYour 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, ***
142521 CFR 110.20(b)(4)20Spacing of equipmentAisles or working spaces between equipment and walls are [obstructed] [of inadequate width]. Specifically, ***
308621 CFR 114.100(b)20Maintenance 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, ***
1274521 CFR 120.8(b)(1)19HACCP plan - food hazards not listedYour HACCP plan does not list all food hazards that are reasonably likely to occur. Specifically, ***
1541021 CFR 111.14(b)(2)19Personnel - records - trainingYou did not make and keep documentation of training. Specifically, ***
91821 CFR 123.8(a)18Verification - 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, ***
160121 CFR 110.37(a)18Safe and adequate sanitary qualityFailure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces. Specifically, ***
995821 CFR 120.12(c)18Records - signed/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, ***
1620421 CFR 118.10(b)(2)18Date and time of activityAll your required records do not include the [date] [time] of the activity that the records reflect. Specifically,***
602221 CFR 123.12(c)17Lack 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, ***
1545321 CFR 111.1617Written procedures - cleaningYou did not [establish] [follow] written procedures for cleaning the physical plant. Specifically, ***
1601321 CFR 111.140(b)(1)17Records - quality control operations; responsibilitiesYou did not make and keep written procedures for the responsibilities of the quality control operations. Specifically, ***
91321 CFR 123.8(a)(1)16Reassessment 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, ***
238521 CFR 110.80(a)(1)16Inspection, segregation, handling of raw materialsFailure to [inspect] [segregate] [handle] raw materials to ascertain that they are clean and suitable for processing into food. Specifically, ***
446421 CFR 108.25(c)(1)16RegistrationFailure 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, ***
1564221 CFR 111.455(a)16Hold - temperature, humidity, lightYou did not hold [components] [dietary supplements] under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected. Specifically, ***
1582521 CFR 111.6516Quality control - quality, dietary supplementYou did not implement quality control operations to ensure the quality of the dietary supplement. Specifically, ***
133021 CFR 113.100(a)15Processing 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, ***
171121 CFR 110.80(b)(15)15Proper 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, ***
239421 CFR 110.80(b)(6)15Contamination by raw materials, refuse, other ingredientsFailure to take effective measures to protect finished food from contamination by [raw materials] [refuse] [other ingredients] . Specifically, ***
308521 CFR 114.100(a)15Raw 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, ***
387721 CFR 113.60(c)15Coding - required elementsThe required container identification fails to include the [establishment where packed] [product] [year packed] [day packed] [period during which packed]. Specifically, ***
1274821 CFR 120.8(b)(5)15HACCP plan - corrective action plan not includedYour 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,***
1549421 CFR 111.25(c)15Procedures - equipment - cleaning, sanitizingYou did not [establish] [follow] written procedures for maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
1593221 CFR 111.105(a)15Processes, specifications, written proceduresYour quality control personnel did not approve or reject [processes] [specifications] [written procedures] [controls] [tests] [examinations] [deviations or modifications] that may affect the identity, purity, strength, or composition of a dietary supplement. Specifically, ***
1604021 CFR 111.610(a)15Records - available; FDAYou did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested. Specifically, ***
1612221 CFR 118.4(a)(2)(i)15Pullet environment testingYour pullet environment is not tested for SE when pullets are 14 to 16 weeks of age. Specifically,***
93221 CFR 123.7(d)14Corrective action documentationYou do not have records that document corrective actions that were taken. Specifically, ***
238821 CFR 110.80(a)(5)14Holding 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, ***
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, ***
601421 CFR 123.6(c)(2)14Monitoring - 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,
993021 CFR 120.6(c)14SSOP 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, ***
994121 CFR 120.8(a)14No 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, ***
1274621 CFR 120.8(b)(2)14HACCP plan - critical control points not listedYour HACCP plan does not list the critical control points for each of the identified food hazards. Specifically, ***
1540121 CFR 111.12(b)14Personnel - quality control operationsYou have not identified personnel to be responsible for your quality control operations. Specifically, ***
1581921 CFR 111.5514Production, process controls - implementYou did not implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the dietary supplement. Specifically, ***
1619321 CFR 118.10(a)(3)(ii)14Rodent and pest control documentationYou did not maintain records documenting compliance with rodent and other pest control measures. Specifically,***
1620321 CFR 118.10(b)(1)14Name and locationAll required records do not include [your name] [the location of your farm]. Specifically,***
157721 CFR 110.37(f)13Contamination 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, ***
307321 CFR 114.80(a)(2)13pH 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, ***
365721 CFR 110.37(d)(4)13Doors 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, ***
451521 CFR 108.35(c)(2)13Process 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, ***
993521 CFR 120.7(a)13No 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, ***
1540421 CFR 111.12(c)13Personnel - education, training, experiencePersonnel engaged in [manufacturing] [packaging] [labeling] [holding] dietary supplements do not have the education, training, or experience to perform the person's assigned functions. Specifically, ***
1556621 CFR 111.260(l)(3)13Batch record - approved, released, rejected; batchYour batch production records did not include documentation that quality control personnel approved and released, or rejected, a batch for distribution. Specifically, ***
1570221 CFR 111.320(b)13Examination, testing; scientifically validYou did not identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification was met. Specifically, ***
1583821 CFR 111.70(d)13Specifications - labels, packagingYou did not establish [label] [packaging] specifications.  Specifically, ***
1611821 CFR 118.413Written SE plan not implemented/followedYour written SE prevention plan is not [fully] implemented and followed. Specifically,***
112921 CFR 110.40(a)12Food-contact - corrosion resistantLack of corrosion-resistant food contact surfaces. Specifically, ***
160021 CFR 110.37(a)12General inadequacyFailure to use a water supply that is [sufficient for the operations] [derived from an adequate source]. Specifically, ***
239621 CFR 110.80(b)(6)12Conveyor transportationFailure to take effective measures to protect food transported by conveyor from contamination. Specifically, ***
306221 CFR 114.1012PersonnelOperators 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, ***
451121 CFR 108.25(f)12Approved 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, ***
995421 CFR 120.11(a)(1)(iv)12Verification - CCP, CA record reviewYou 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, ***
15351FDCA 761(b)(1)12No AE report made (dietary supplement)No report was made of a serious adverse event associated with a dietary supplement marketed in the United States. Specifically, ***
1542521 CFR 111.15(i)12Hand-washing facilitiesYour hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a suitable temperature]. Specifically, ***
1549621 CFR 111.27(b)12Instruments - calibrationYou did not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement [before the first use] [at the frequency specified in writing by the manufacturer or at routine intervals or as necessary] to ensure the accuracy and precision of the instruments or controls. Specifically, ***
1582821 CFR 111.70(a)12Specifications - manufacturing processYou did not establish a specification for a point, step, or stage in the manufacturing process where control is necessary to ensure [the quality of the dietary supplement] [that the dietary supplement is packaged and labeled as specified in the master manufacturing record]. Specifically, ***
1587121 CFR 111.75(c)(2)12Specifications met - test, examinations; complianceYou did not conduct appropriate tests or examinations to determine compliance with the specifications established for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement]. Specifically, ***
1620521 CFR 118.10(b)(3)12Signatures or initials on operational recordsAll required records do not have the signature or initials of the person performing the operation or creating the record. 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, ***
98621 CFR 110.10(b)(2)11Personal cleanlinessEmployees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness. Specifically, ***
131621 CFR 113.87(c)11Initial temperatureThe initial temperature of the contents of a container to be processed was [not determined] [not recorded] with sufficient frequency to ensure the temperature was not lower than the minimum initial temperature stated in the scheduled process. Specifically, ***
164121 CFR 113.100(b)11Review 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, ***
306721 CFR 114.80(a)11Quality control proceduresAppropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard. Specifically, "***
309021 CFR 114.100(d)11Product distributionRecords identifying initial distribution of finished product are not maintained. Specifically, ***
366221 CFR 110.37(e)(6)11Refuse receptaclesRefuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food. Specifically, ***
447921 CFR 108.25(e)11Recall 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, ***
451921 CFR 108.35(c)(3)(i)11Process adherenceFailure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, ***
600221 CFR 123.11(b)11Sanitation correctionsYou did not correct sanitation deficiencies in a timely manner. Specifically,***
992821 CFR 120.12(b)11Records - general - include name, date, timeYour 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, ***
993921 CFR 120.7(c)11All hazards not consideredIn 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, ***
1274321 CFR 120.8(b)(4)11HACCP plan - monitoring procedures not adequateYour HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure compliance with the critical limits. Specifically, ***
1275521 CFR 120.11(a)(1)(iv)11Records - not signed and dated by qualified individualYour 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, ***
1540921 CFR 111.14(b)(1)11Personnel - records - written proceduresYou did not make and keep written procedures for [preventing microbial contamination from sick or infected personnel] [hygienic practices] [determining personnel qualification requirements]. Specifically, ***
1554321 CFR 111.260(c)11Batch record - date, time; maintenanceYour batch production records did not include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained. Specifically, ***
1612021 CFR 118.411Written SE plan lacks required elementsYour written SE prevention plan lacks appropriate SE prevention measures. Specifically,***
156621 CFR 110.35(d)(4)10Single-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, ***
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, ***
242721 CFR 110.80(b)(9)10Proper disposal of adulterated productFailure to dispose of adulterated [food] [raw materials] in a manner which protects against the contamination of other food. Specifically, ***
307521 CFR 114.80(a)(4)10Container testingFailure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination. Specifically, ***
365321 CFR 110.37(d)10Readily accessibleFailure to provide employees with [readily accessible] [adequate] toilet facilities. Specifically, ***
1545421 CFR 111.1610Written procedures - pest controlYou did not [establish] [follow] written procedures for pest control. Specifically, ***
1574721 CFR 111.210(g)10Packaging description, representative labelYour master manufacturing record did not include a [description of the packaging] [a representative label, or a cross-reference to the physical location of the actual or representative label]. Specifically,
1584021 CFR 111.70(e)10Specifications -contamination limitsYou did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement. Specifically, ***
1586221 CFR 111.75(a)(2)10Appropriate tests, examinations; certificate of analysisYou did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications. Specifically, ***
1593521 CFR 111.105(d)10Quality control - basis; tests, examinationsYour quality control personnel did not review and approve the documentation setting forth the basis for why the results of appropriate tests or examinations for each product specification will ensure that the finished batch of the dietary supplement meets product specifications. Specifically, ***
1598421 CFR 111.123(a)(8)10Quality control - finished batch, distributionYour quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution. Specifically, ***
1598621 CFR 111.123(b)(2)10Quality control - batch, product specificationsYour quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications. Specifically, ***
1613521 CFR 118.4(b)(4)10Stray animalsStray animals are not prevented from entering poultry houses. Specifically,***
95021 CFR 123.12(d)9Determination 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, ***
147221 CFR 113.839Critical factors not statedCritical factors that may affect the scheduled process are not specified in the scheduled process. Specifically, ***
164221 CFR 113.100(b)9Review 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, ***
308921 CFR 114.100(c)9Process 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, ***
447521 CFR 108.25(c)(3)(i)9Process adherenceFailure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, ***
600921 CFR 123.8(a)(3)(iii)9Verification - record review - calibrationYou did not review [some of] your calibration records within a reasonable time after the records were made. Specifically, ***
993221 CFR 120.6(a)9Sanitation SSOP - none 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, ***
994321 CFR 120.8(a)9HACCP plan - location and type of juiceYour HACCP plan is not specific to [each location where juice is processed] [each type of juice processed]. Specifically, ***
1273421 CFR 120.12(a)9Records required - 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, ***
1274921 CFR 120.8(b)(6)9HACCP plan - verify procedures / frequency - none listedYour HACCP plan does not list the verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is being implemented. Specifically, ***
1540221 CFR 111.129Personnel - quality control personnel - qualifiedThe personnel you identified to perform quality control operations [are not qualified to do so] [do not have the education, training or experience to perform the assigned functions]. Specifically, ***
1564521 CFR 111.455(c)9Hold - mix-up, contamination, deteriorationYou held [components] [dietary supplements] [packaging] [labels] under conditions that lead to mix-up, contamination, or deterioration. Specifically, ***
1573321 CFR 111.3659Manufacturing operations - prevent contaminationYou did not take necessary precautions during the manufacture of a dietary supplement to prevent contamination of [components] [dietary supplements]. Specifically, ***
1574421 CFR 111.210(h)(2)9Master manufacturing record - sampling, tests, examinationsThe written instructions in your master manufacturing record did not include [procedures for sampling] [a cross-reference to procedures for tests or examinations]. Specifically, ***
1583221 CFR 111.70(c)(1)9In-process identity, purity, strength, compositionYou did not establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for [identity] [purity] [strength] [composition]. Specifically, ***
1588221 CFR 111.75(h)(2)9Tests, examinations - scientifically validYou did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods. Specifically, ***
1615221 CFR 118.5(a)9Testing when laying hens 40 to 45 weeksEnvironmental testing for SE, using approved methods, was not done in a poultry house when any group of laying hens constituting the flock was 40 to 45 weeks of age. Specifically,***
1619221 CFR 118.10(a)(3)(1)9Biosecurity measures documentationYou did not maintain records documenting compliance with biosecurity measures. Specifically,***
156821 CFR 110.35(d)(2)8Before 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, ***
236221 CFR 110.808Reject 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, ***
238921 CFR 110.80(a)(5)8Identify reworkFailure to identify material scheduled for rework as such. Specifically, ***
366021 CFR 110.37(e)(4)8Devices and fixturesDevices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands. Specifically, ***
442121 CFR 110.20(a)8Maintenance of groundsMaintenance of the grounds is inadequate to protect against contamination of food. Specifically, ***
994721 CFR 120.11(b)8HACCP plan - not validatedYou 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, ***
1530221 CFR 120.11(a)(2)8Calibration, testing - no recordsYou do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing]. Specifically, ***
1543721 CFR 111.15(a)(1)8Grounds - equipment, litter, weedsYou did not [properly store equipment] [remove litter and waste] [cut weeds or grass] within the immediate vicinity of the physical plant. Specifically, ***       
1566521 CFR 111.3038Written procedures - tests, examinations; specifications metYou did not [establish] [follow] written procedures for the tests and examinations conducted to determine whether specifications are met. Specifically, ***
1571521 CFR 111.375(b)8Records - manufacturing operations; written proceduresYou did not make and keep records of the written procedures for manufacturing operations. Specifically, ***
1574621 CFR 111.210(h)(1)8Instructions; specifications; qualityThe written instructions in your master manufacturing record did not include specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Specifically, ***
1575921 CFR 111.205(b)(2)8Master manufacturing record - controls, proceduresYour master manufacturing record did not establish [controls] [procedures] to ensure that each batch met specifications. Specifically, ***
1580021 CFR 111.560(a)(2)8Product complaint - quality control investigateA qualified person did not investigate a product complaint that involved a possible failure of a dietary supplement to meet a specification, or other requirement. Specifically, ***
1587221 CFR 111.75(c)(3)8Specifications met identity,purity, strength, comp,; basisYou did not provide adequate documentation of your basis for determining that compliance with the specification[s] you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specification[s]. Specifically, ***
1588521 CFR 111.77(a)8Specifications not met - reject, quality controlYour quality control personnel did not reject a [component] [dietary supplement] [package] [label] for which a specification was not met. Specifically, ***
1589321 CFR 111.80(c)8Specifications - representative samples; finished batchYou did not collect representative samples [of a subset] of finished batches of dietary supplements that you manufacture [before releasing for distribution] to verify that the finished batch of dietary supplement meets established product specifications. Specifically, ***
1605821 CFR 111.535(b)(2)8Records - ret'nd dietary supplement: material review, disposYou did not make and keep records of a material review and disposition decision on a returned dietary supplement. Specifically, ***
1617921 CFR 118.8(a)8Method to be used, environmental samplesFor testing to detect SE in environmental samples, you did not have the sample testing conducted by the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses." most current edition, or an equivalent method in accuracy, precision and sensitivity in detecting SE. Specifically,***
1619521 CFR 118.10(a)(3)(iv)8Refrigeration requirements documentationYou do not maintain records documenting compliance with refrigeration requirements. Specifically***
97521 CFR 123.9(b)(1)7Record retentionYour [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period. Specifically, ***
148721 CFR 113.87(b)7Visual 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, ***
170821 CFR 110.80(b)(12)7Batters, 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, ***
227521 CFR 129.80(g)(2)7Chemical, 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, ***
308221 CFR 114.897Process 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, ***
429621 CFR 110.80(a)(5)7Temperature and humidityFailure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming adulterated. Specifically, ***
447621 CFR 108.25(c)(3)(ii)7Process information availabilityFailure to provide the FDA, after written request, any process and procedure information deemed necessary to determine the adequacy of the process. Specifically, ***
452421 CFR 108.35(g)7Approved 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, ***
992621 CFR 120.14(a)7Importer - written proceduresYou 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, ***
996121 CFR 120.24(a)7Process controls - HACCP plan - 5 log 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, ***
1272121 CFR 1.2347Registration 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, ***
1274721 CFR 120.8(b)(3)7HACCP plan - critical limits not listed or not adequateYour 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, ***
1543421 CFR 111.15(d)(2)7Pest control measuresYou did not take effective measures [to exclude pests from the physical plant] [to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests]. Specifically, ***
1544321 CFR 111.15(b)(2)7Physical plant - repairYou did not maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated. Specifically, ***
1548021 CFR 111.20(h)7Physical plant - screening against pestsYour physical plant did not use adequate screening or other protection against pests. Specifically, ***
1549121 CFR 111.257Equipment - proceduresYou did not [establish] [follow] written procedures for fulfilling the requirements for equipment and utensils. Specifically, ***
1549221 CFR 111.25(a)7Procedures - calibrating instrumentsYou did not [establish] [follow] written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement. Specifically, ***
1554421 CFR 111.260(d)7Batch record - component; unique identifierYour batch production records did not include the unique identifier that you assigned to [a component] [a product that you received from a supplier for packaging or labeling as a dietary supplement] [the packaging used] [the label used]. Specifically, ***
1557021 CFR 111.1537Written procedures - componentsYou did not [establish] [follow] written procedures for the requirements for components of dietary supplements. Specifically, ***
1573721 CFR 111.210(h)(5)7Corrective action plansThe written instructions in your master manufacturing did not include instructions for corrective action plans to use when specifications are not met. Specifically, ***
1578521 CFR 111.410(b)7Label, packaging - discrepanciesYou did not control the reconciliation of any issue and use [label discrepancies] [packaging discrepancies]. Specifically, ***
1583121 CFR 111.70(b)(3)7Specifications - contamination limitsYou did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement. Specifically, ***
1585321 CFR 111.737Specifications met - identity, purity, strength, compositionYou did not determine whether you met established product specifications for [identity] [purity] [strength] [composition of the finished batch of the dietary supplement]. Specifically, ***
1597521 CFR 111.120(e)7Quality control operations - quarantineYour quality control operations did not include approving, and releasing from quarantine, all [components] [packaging] [labels] before they were used. Specifically, ***
1614221 CFR 118.4(c)(3)7Removal of pest harboragesPotential harborages for pests in and outside your poultry house have not been eliminated by [removing debris within a poultry house] [removing debris and vegetation outside the poultry house]. Specifically,***
119621 CFR 110.10(a)6Employees 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, ***
147121 CFR 113.836Scheduled processes not establishedScheduled processes for low-acid foods have not been established by qualified persons having expert knowledge of thermal processing. Specifically, ***
153421 CFR 113.100(b)6Entries 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, ***
173421 CFR 113.40(a)(2)6Corresponding 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, ***
229821 CFR 129.80(f)6Inspection of containers and closuresYou do not [sample] [inspect] all containers and closures to ascertain they are free from contamination. Specifically, ***
365121 CFR 110.37(b)(5)6Cross contaminationSystems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing. Specifically, ***
429521 CFR 110.40(a)6Food contact - non-toxic materialsFood-contact surfaces are not made of non-toxic materials. Specifically, ***
601721 CFR 123.7(c)6Corrective 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, ***
998621 CFR 120.24(c)6Process controls - not exempt, single facilityYou 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, ***
1547821 CFR 111.20(f)6Physical plant - bulbs, fixtures, skylightsYou did not use safety-type [light bulbs] [fixtures] [skylights] [glass] over exposed components or dietary supplements. Specifically, ***
1548121 CFR 111.23(b)6Records - cleaning, pest controlYou did not make and keep records of the written procedures for [cleaning the physical plant] [pest control]. Specifically, ***
1549821 CFR 111.27(d)6Equipment - maintain, clean, sanitizeYou did not [maintain] [clean] [sanitize] equipment and utensils used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
1554621 CFR 111.260(f)6Batch record - yieldYour batch production records did not include [a statement of the actual yield] [a statement of the percentage of theoretical yield] at appropriate phases of processing. Specifically, ***
1554821 CFR 111.260(h)6Batch record - results; testing, examination; batchYour batch production records did not include the results of testing or examination performed during batch production, or a cross-reference to such results. Specifically, ***
1555021 CFR 111.260(j)6Batch record - manufactureYour batch production records did not include documentation, at the time of performance, of the manufacture of the batch. Specifically, ***
1555921 CFR 111.260(k)(1)6Batch record - identifier; labelsYour batch production records did not include [the unique identifier assigned to labels used] [the quantity of the labels used] [reconciliation of discrepancies between issuance and use of labels]. Specifically, ***
1556721 CFR 111.260(l)(4)6Batch record - approved, released, rejectedYour batch production records did not include documentation that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement. Specifically, ***
1565221 CFR 111.465(b)6Retain reserve samples - 1 year, 2 yearsYou did not retain reserve samples for the required time. Specifically, ***
1579021 CFR 111.4036Written procedures - labeling operationsYou did not [establish] [follow] written procedures for labeling operations. Specifically, ***
1584321 CFR 111.70(g)6Specifications - finished packaging, labelingYou did not establish specifications [for the packaging and labeling of the finished dietary supplement] [to ensure that you used the specified packaging] [to ensure that you applied the specified label]. Specifically, ***
1587021 CFR 111.75(c)(1)6Specifications met - verify; production, process controlYou did not select one or more established specifications for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement] that, if tested or examined on the finished batches of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications. Specifically, ***
1589121 CFR 111.80(a)6Components packaging, labels receivedYou did not collect representative samples of each unique lot of [components] [packaging] [labels] that you received from a supplier to determine whether the [components] [packaging] [labels] meet[s] established specifications. Specifically, ***
1589821 CFR 111.83(b)(1)6Reserve sample -container-closure systemYour reserve sample of a dietary supplement was not held using the same container-closure system in which the packaged and labeled dietary supplement was distributed. Specifically, ***
1592821 CFR 111.1036Written procedure quality control operations material reviewYou did not [establish] [follow] written procedures for quality control operations for conducting a material review and making a disposition decision. Specifically, ***
1600821 CFR 111.1356Quality control operations - product complaints; investigateYour quality control operations for product complaints did not include [reviewing and approving decisions about whether to investigate a product complaint] [reviewing and approving the findings and follow-up action of any investigation performed]. Specifically, ***
117621 CFR 110.40(f)5Insufficient 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,***
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, ***
129021 CFR 110.20(a)(4)5Waste 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, ***
132921 CFR 113.100(a)5Processing 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, ***
142821 CFR 110.20(b)(6)5Adequate ventilationFailure to provide [adequate ventilation] [control equipment] to minimize odors and vapors in areas where they may contaminate food. Specifically, ***
148321 CFR 113.87(a)5Operating processes not postedOperating processes for each product and container size were not [posted in a conspicuous place near the processing equipment] [readily available to the retort or processing system operator] [readily available to FDA investigators]. Specifically, ***
150021 CFR 113.895Evaluation by process authorityFailure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority. Specifically, ***
164021 CFR 113.100(b)5Entries not signedThe retort or processing system operator or other designated person did not initial or sign each record form.   Specifically, ***
166921 CFR 110.80(a)(3)5Aflatoxin 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, ***
210121 CFR 113.40(a)(13)5Measured, 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, ***
227421 CFR 129.80(g)(1)5BacteriologicalYou 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, ***
288621 CFR 113.40(i)5Inadequate 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, ***
288721 CFR 113.40(j)5Conform 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, ***
307221 CFR 114.80(a)(1)5Thermal 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, ***
307721 CFR 114.80(b)5Visible codeEach container is not marked with an identifying code permanently visible to the naked eye. Specifically, ***
308821 CFR 114.100(b)5Processing 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, ***
365021 CFR 110.35(d)(1)5Wet cleaningFailure to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned. Specifically, ***
418121 CFR 113.895Process deviation identificationFailure to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control. Specifically, ***
451421 CFR 108.35(c)(1)5RegistrationFailure to register with the FDA information including the name, principal place of business and the location of the processing establishment within 10 days after engaging in the manufacture, processing and packaging of low-acid canned foods. Specifically, ***
601221 CFR 123.8(a)(3)(iii)5Calibration 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, ***
994621 CFR 120.11(b)5Validation - reviewer's qualificationsYour [validation of the HACCP plan] [validation of the hazard analysis] was not done by an individual who had successfully completed training in the application of HACCP principles to juice processing or otherwise qualified through job experience to perform these function. Specifically, ***
1538121 CFR 111.85Written procedures - hygienic practicesYou did not [establish] [follow] written procedures for hygienic practices. Specifically, ***
1545821 CFR 111.20(d)(1)(i)5Floors, walls, ceilingsYour [floors] [walls] [ceilings] were not designed and constructed so they can be adequately cleaned and kept clean and in good repair. Specifically, ***
1550721 CFR 111.27(a)(5)(i)5Refrigerator, freezer - temperature recording deviceYour freezer, refrigerator, or other cold storage compartment that you use to hold components or dietary supplements does not have an indicating thermometer, temperature-measuring device, or temperature-recording device that indicates and records, or allows for recording by hand, the accurate temperature within the compartment. Specifically, ***
1552521 CFR 111.30(b)5Equipment - automated - suitabilityYou did not determine the suitability of the automated, mechanical, or electronic equipment by ensuring that the equipment is capable of operating satisfactorily within the operating limits required by the process. Specifically, ***
1552621 CFR 111.30(c)5Equipment - automated - calibrate, inspectYou did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to ensure proper performance. Specifically, ***
1553321 CFR 111.255(c)5Batch record - follow masterYour batch production record did not accurately follow the appropriate master manufacturing record. Specifically, ***
1554221 CFR 111.260(b)5Batch record - date, time; maintenanceYour batch production records did not include the identity of equipment and processing lines used in producing the batch. Specifically, ***
1555421 CFR 111.260(j)(2)(ii)5Batch record - initials; verifying weightYour batch production records did not include the initials of the person responsible for verifying the weight or measure of each component used in the batch. Specifically, ***
1555621 CFR 111.260(j)(2)(iv)5Batch record - initials; verifying componentYour batch production records did not include initials of the person responsible for verifying the addition of components to the batch. Specifically, ***
1555821 CFR 111.260(k)(1)5Batch record - identifier; packagingYour batch production records did not include [the unique identifier assigned to packaging used] [the quantity of the packaging used]. Specifically, ***
1556021 CFR 111.260(k)(2)5Batch record - labelYour batch production records did not include an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record. Specifically, ***
1557821 CFR 111.155(c)5Components - quarantineYou did not quarantine components before you used them in the manufacture of a dietary supplement. Specifically, ***
1562321 CFR 111.180(b)(2)5Records - receiving; components, packaging, labels, productsYou did not make and keep receiving records for [components] [packaging] [labels] [products you received for packaging or labeling as a dietary supplement]. Specifically, ***
1566221 CFR 111.3035Written procedures - laboratory operationsYou did not [establish] [follow] written procedures for laboratory operations. Specifically, ***
1576121 CFR 111.205(b)(1)5Master manufacturing record - specifications; qualityYour master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Specifically, ***
1578421 CFR 111.410(c)5Packaging, labels - master manufacturing recordYou did not examine, before [packaging] [labeling] operations, [packaging] [labels] for each batch of dietary supplement to determine whether the [packaging] [labels] conformed to the master manufacturing record. Specifically, ***
1581721 CFR 111.570(b)(2)(ii)(F)5Record - product complaint; findingsThe written record of a product complaint did not include the [findings of the investigation] [follow-up action taken]. Specifically, ***
1586321 CFR 111.75(a)(2)(ii)(B)5Component - certificate of analysisThe certificate of analysis for a component does not include [a description of the test or examination method(s) used] [limits of the test or examination] [actual results of the tests or examinations]. Specifically, ***
1590221 CFR 111.83(b)(4)5Reserve sample - twice the quantityYour reserve sample did not consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications. Specifically, ***
1592121 CFR 111.95(b)(2)5Documentation - supplier qualificationYou did not make and keep documentation of your qualification of a supplier. Specifically, ***
1593321 CFR 111.105(b)5Quality control - supplier qualificationYour quality control personnel did not review and approve the documentation setting forth the basis for qualification of suppliers. Specifically, ***
1597221 CFR 111.120(b)5QC operations -specifications; components, packaging, labelsYour quality control operations did not include determining whether [components] [packaging] [labels] conform to established specifications. Specifically, ***
1598921 CFR 111.1275Quality control operations - packaging, labelingYou do not have quality control operations for [packaging] [labeling]. Specifically, ***
1601421 CFR 111.140(b)(1)5QC ops; written procedures; material review, dispositionYou did not make and keep [written procedures for the responsibilities of the quality control operations for conducting a material review and making a disposition decision] [written procedures for approving or rejecting any reprocessing]. Specifically, ***
1604721 CFR 111.5105Returned dietary supplement - material review, dispositionYou did not identify and quarantine returned dietary supplements until quality control personnel conducted a material review and made a disposition decision. Specifically, ***
16089FDCA 417(d)(1)(A)5Reportable food report - submissionYou did not submit a reportable food report to FDA within 24 hours after you determined that a food was a reportable food. Specifically, ***
1611721 CFR 118.45No written SE prevention planYour firm does not have a written SE prevention plan that is specific to [each farm] [the farm] where you produce eggs. Specifically,***
1613421 CFR 118.4(b)(3)5Cross contamination from peopleYou do not maintain practices that will protect against cross contamination when people move between poultry houses. Specifically,***
1614121 CFR 118.4(c)(2)5Satisfactory fly control methodsWhen your monitoring indicated unacceptable fly activity within a poultry house, appropriate methods were not used to achieve satisfactory fly control. Specifically,***
1620621 CFR 118.10(b)(3)5Signature and date on SE plansYour written SE plan does not [bear a date] [carry the signature(s) and not the initials of the person(s) who administer the plan]. Specifically,***
93821 CFR 123.9(c)4Official reviewYou did not make available for official review and copying at reasonable times [all records] [all plans and procedures] required by the regulations. Specifically, ***
109321 CFR 110.40(g)4Compressed 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, ***
131721 CFR 113.87(d)4Timing devicesFailure to provide accurate timing devices to ensure that the processing and venting times specified in the scheduled process are achieved. Specifically, ***
133121 CFR 113.100(a)(1)4Still 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, ***
152921 CFR 113.894Process deviation log/fileProcess deviations were not recorded in a separate file or log that details both the deviations and the actions taken. Specifically, ***
164321 CFR 113.100(c)4Incomplete 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, ***
165121 CFR 113.40(a)(1)4Thermometer calibrationMercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon installation] [yearly] to ensure accuracy. Specifically, ***
166021 CFR 113.40(a)(1)4MIG thermometer not used as referenceThe mercury-in-glass thermometer was not the reference thermometer for indicating processing temperatures.   Specifically, ***
166521 CFR 110.80(a)(2)4Pasteurization 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, ***
167021 CFR 110.80(a)(4)4Safety 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, ***
173521 CFR 113.40(a)(2)4Unauthorized adjustmentThere was no means to prevent unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
227121 CFR 129.80(e)4Package 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, ***
230121 CFR 129.80(f)4Bacteriological 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, ***
308321 CFR 114.894Process deviation evaluationProcess deviations are not evaluated by a competent processing authority in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health. Specifically, ***
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, ***
452321 CFR 108.35(f)4Recall 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, ***
998121 CFR 120.12(b)(4)4Records - actual valuesYour records do not [always] contain the actual values and observations obtained during monitoring. Specifically, ***
1273221 CFR 120.10(a)4Corrective 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, ***
1275021 CFR 120.8(b)(6)4HACCP plan - valid procedures / frequency - none listedYour 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, ***
1544221 CFR 111.15(b)(1)4Physical plant - clean and sanitaryYou did not maintain your physical plant in a clean and sanitary condition. Specifically, ***
1545221 CFR 111.15(f)(5)4Plumbing - backflow, cross connectionThe plumbing in your physical plant allows [backflow from] [cross connection between] piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities. Specifically, ***
1554521 CFR 111.260(e)4Batch record - component; identity, weightYour batch production records did not include the [identity] [weight or measure] of each component used. Specifically, ***
1554721 CFR 111.260(g)4Batch record - results; monitoringYour batch production records did not include the actual results obtained during a monitoring operation. Specifically, ***
1557321 CFR 111.1534Written procedures - product received; packaging, labelingYou did not [establish] [follow] written procedures for the requirements for product received for packaging or labeling as a dietary supplement. Specifically, ***
1558321 CFR 111.155(d)(1)4Components - identify lot receivedYou did not identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the component] [the status of the component] [the dietary supplement that you manufactured and distributed]. Specifically, ***
1558921 CFR 111.160(c)4Packaging, labels - quarantineYou did not quarantine [packaging] [labels] before you used them in the manufacture of a dietary supplement. Specifically, ***
1562421 CFR 111.180(b)(3)4Documentation - componentsYou did not make and keep documentation that the requirements that apply to production and process control for components of dietary supplements were met. Specifically, ***
1566021 CFR 111.475(b)(2)4Records - product distributionYou did not make and keep records of product distribution. Specifically, ***
1567521 CFR 111.315(b)4Sampling plans; establish, followYou did not [establish] [follow] sampling plans for obtaining representative samples. Specifically, ***
1568121 CFR 111.315(d)4Standard reference materials; criteria for selectingYou did not [establish] [follow] laboratory control processes for use of criteria for selecting standard reference materials used in performing tests and examinations. Specifically, ***
1570821 CFR 111.325(a)4Written procedures, laboratory operationsYou did not make and keep written procedures for laboratory operations. Specifically, ***
1571221 CFR 111.325(b)(2)(ii)4Records - document; resultsThe documentation for laboratory tests and examinations did not include the results of the testing and examination. Specifically, ***
1572321 CFR 111.365(i)4Metal, foreign materialYou did not use effective measures to protect against the inclusion of metal or other foreign material in [components] [dietary supplements]. Specifically, ***
1573421 CFR 111.3604Manufacturing operations - sanitationYou did not conduct manufacturing operations in accordance with adequate sanitation principles. Specifically, ***
1573621 CFR 111.3534Manufacturing operations - written proceduresYou did not [establish] [follow] written procedures for manufacturing operations. Specifically, ***
1574521 CFR 111.210(h)(1)4Instructions; specifications; packaged, labeledThe written instructions in your master manufacturing record did not include specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Specifically, ***
1574821 CFR 111.210(f)4Master manufacturing record theoretical yield,expected yieldYour master manufacturing record did not include a statement of [the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control] [the expected yield of the finished dietary supplement.] Specifically, ***
1575121 CFR 111.210(d)4Master manufacturing record - Supplemental FactsYour master manufacturing record did not include the [identity] [weight or measure] of each dietary ingredient that will be declared on the Supplement Facts label. Specifically, ***
1582121 CFR 111.60(a)4Production, in- process control system - design, qualityYour production and in-process control system is not designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement. Specifically, ***
1586421 CFR 111.75(a)(2)(ii)(C)4Documentation - qualify supplierYou did not maintain documentation of how you qualified the supplier of a component. Specifically, ***
1595121 CFR 111.110(c)4Quality control operations - tests, examinations; resultsYour quality control operations did not include reviewing and approving the results of required [tests] [examinations]. Specifically, ***
1595221 CFR 111.1134Quality control operations - material review, dispositionYou do not have quality control operations for a material review and disposition decision. Specifically, ***
1595321 CFR 111.113(a)(1)4QC production, process control; material review, dispositionYour quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met. Specifically, ***
1596721 CFR 111.117(b)4Quality control operations - calibration recordsYour quality control operations did not include periodically reviewing all records for calibration of instruments and controls. Specifically, ***
1600721 CFR 111.1354Quality control operations - product complaintsYou do not have quality control operations for product complaints. Specifically, ***
1615321 CFR 118.5(a)(1)4Poultry house has multiple groups of laying hensEnvironmental testing for SE, using approved methods, was not done in a poultry house containing more than one group of laying hens, when each group of laying hens was 40 to 45 weeks of age. Specifically,***
1616421 CFR 118.6(c)4Four egg tests, flock in positive poultry houseYou were required to perform egg testing, but you did not conducted egg testing on the eggs from a flock in an SE positive poultry house [using egg sampling and testing methodology specified in the Code of Federal Regulations] [at two week intervals]. Specifically,***
89921 CFR 123.163Process controlsYour HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. 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, ***
149921 CFR 113.893No 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, ***
155921 CFR 110.35(c)3Guard/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, ***
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, ***
163921 CFR 113.100(b)3Entries not timelyEntries on [processing records] [production records] were not made at the time the specific retort or processing system condition or operation occurred. Specifically, ***
169121 CFR 113.40(a)(4)3Steam controllerFailure to equip retorts with automatic steam controllers to maintain retort temperatures. Specifically, ***
171621 CFR 113.40(a)(11)3Water valves, leakageFailure to supply a suitable water valve used for water cooling to prevent leakage of water into the retort during processing. Specifically, ***
176121 CFR 129.80(a)3Record keeping requirementsYou do not maintain records at the plant pertaining to physical inspection of equipment used for treatment of product water, including the [type and date] [conditions found] [performance and effectiveness of equipment]. Specifically, ***
288821 CFR 113.40(j)3Critical factorsCritical factors are not [measured] [recorded] at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process. Specifically, ***
306821 CFR 114.80(a)(1)3pH 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, ***
385721 CFR 113.60(a)3Record of visual closure examinationFailure to record observations of visual closure examinations performed by a qualified person during production. Specifically, ***
387221 CFR 113.60(a)(3)3Closures other than double seams and glassFailure to [have a qualified person] perform appropriate detailed inspections and tests [at intervals of sufficient frequency] to ensure proper closing machine performance and consistently reliable hermetic seal production. Specifically, ***
387421 CFR 113.60(b)3Cooling water - failure to chlorinate, etc.Failure to chlorinate or otherwise sanitize container cooling water as necessary for cooling canals and recirculated water supplies. Specifically, ***
388621 CFR 113.87(e)3Clock 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, ***
389221 CFR 113.60(a)3Regular observations for gross closure defectsFailure to make regular observations for gross closure defects during production runs. Specifically ***
451721 CFR 108.35(c)(2)(ii)3Process change substantiationFailure to obtain substantiation by a qualified scientific authority as to the adequacy of any intentional change in a previously filed scheduled process, where the change is basic to the adequacy of that scheduled process. Specifically, ***
452021 CFR 108.35(c)(3)(ii)3Process 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, ***
452921 CFR 108.35(c)(2)(ii)3Process 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, ***
601121 CFR 123.8(a)(3)(ii)3Corrective 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, ***
991921 CFR 120.10(a)3Corrective action - predetermined plan inadequateYou did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]. Specifically, ***
1274421 CFR 120.8(b)(4)3HACCP plan - monitoring procedures - none listedYour 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, ***
1530521 CFR 120.14(a)(2)3Importer - implementation of affirmative stepsYou have not implemented affirmative steps to ensure juice you receive for import into the United States was processed in accordance with the juice HACCP regulation. Specifically, ***
1538221 CFR 111.83Written procedures - personnel qualificationsYou did not [establish] [follow] written procedures for determining personnel qualification requirements. Specifically, ***
1539121 CFR 111.10(b)(3)3Hand washingYour personnel did not thoroughly [wash] [wash and sanitize] their hands in an adequate hand-washing facility [before starting work] [at any time when the hands may have become soiled or contaminated]. Specifically, ***
1539921 CFR 111.10(b)(9)3Contamination - extraneous materialsYour personnel did not take the necessary precautions to protect components, dietary supplements, or contact surfaces against contamination with extraneous materials. Specifically, ***
1545921 CFR 111.20(d)3Physical plant - design and constructionYour physical plant was not [designed] [constructed] in a manner that prevents contamination of components, dietary supplements, or contact surfaces. Specifically, ***
1547321 CFR 111.20(c)(7)3Physical plant - separate areas - holdingYou [did not have] [did not use] separate or defined areas of adequate size or other control systems prevent contamination or mix-ups of components or dietary supplements during holding operations. Specifically, ***
1549921 CFR 111.27(a)3Equipment - design - suitableYou did not use equipment or utensils of appropriate design, construction, and workmanship to enable them to be [suitable for its intended use] [adequately cleaned] [properly maintained]. Specifically, ***
1551121 CFR 111.27(d)3Equipment - maintain - generalYou did not [maintain] [clean] [sanitize] equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
1552921 CFR 111.30(e)3Equipment - controls, intended useYou did not [establish] [use] appropriate controls to ensure that your automated, mechanical, or electronic equipment functions in accordance with its intended use. Specifically, ***
1554921 CFR 111.260(i)3Batch record - specificationsYour batch production records did not include documentation that the finished dietary supplement meets established specifications. Specifically, ***
1555121 CFR 111.260(j)(1)3Batch record - date, each stepYour batch production records did not include the date on which each step of the master manufacturing record was performed. Specifically, ***
1556221 CFR 111.260(l)(1)3Batch record - quality control review; productionYour batch production records did not include documentation that quality control personnel reviewed the batch production record. Specifically, ***
1557221 CFR 111.1533Written procedures - labelsYou did not [establish] [follow] written procedures for the requirements for labels received. Specifically, ***
1558021 CFR 111.155(c)(2)3Quality control - components; tests, examination resultsYour quality control personnel did not review and approve the results of [tests] [examinations] conducted on components while the components were quarantined. Specifically, ***
1558121 CFR 111.155(c)(3)3Quality control - components, approve, releaseYour quality control personnel did not [approve components while the components were quarantined] [release components from quarantine] for use in the manufacture of a dietary supplement. Specifically, ***
1561921 CFR 111.180(b)(1)3Written procedures - packaging, labeling receivedYou did not make and keep written procedures for fulfilling the requirements that apply to packaging and labeling received. Specifically, ***
1564621 CFR 111.460(a)3Hold, identify - in-process materialYou did not identify and hold in-process material under conditions that protect against mix-up, contamination, or deterioration. Specifically, ***
1569821 CFR 111.320(a)3Examination, testing; appropriateYou did not verify that the laboratory examination and testing methodologies are appropriate for their intended use. Specifically, ***
1570621 CFR 111.325(a)3Laboratory operations: electronicYour electronic records for your laboratory operations do not comply with the electronic records requirements. Specifically,
1574321 CFR 111.210(h)(3)3Master manufacturing record - specific actions; qualityThe written instructions in your master manufacturing record did not include specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Specifically, ***
1575221 CFR 111.210(c)3Master manufacturing record - components; weight, measureYour master manufacturing record did not include an accurate weight or measure of each component to be used. Specifically, ***
1578021 CFR 111.4153Fill, assemble, package, label - master recordYou did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a way that ensured that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Specifically, ***
1578621 CFR 111.410(b)3Labels - issuance, useYou did not control the [issuance] [use] of labels, Specifically, ***
1579121 CFR 111.4033Written procedures -packaging operationsYou did not [establish] [follow] written procedures for packaging operations. Specifically, ***
1580221 CFR 111.560(c)3Product complaint - review, investigationYour review and investigation of a product complaint did not extend to all relevant batches and records. Specifically, ***
1582021 CFR 111.553Production, process controls - packaged, labeledYou did not implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record. Specifically, ***
1584521 CFR 111.733Specifications met - qualityYou did not determine whether you met specifications established to ensure the quality of the dietary supplement. Specifically, ***
1586021 CFR 111.75(a)(2)3Component - confirm identity; specifications metYou did not confirm the identity of components. Specifically, ***
1589921 CFR 111.83(b)(1)3Reserve sample container-closure contamination,deteriorationYour reserve sample of a dietary supplement that was distributed to be  packaged and labeled was not held using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it was distributed for packaging and labeling elsewhere. Specifically, ***
1592021 CFR 111.95(b)(1)3Records - established specificationsYou did not make and keep records of established specifications. Specifically, ***
1593021 CFR 111.1053Ensure quality; package, labeled, master recordYour quality control personnel did not ensure that your [manufacturing] [packaging] [labeling] [holding] operations ensure the quality of the dietary supplement. Specifically, ***
1594121 CFR 111.105(i)3QC required operations production and process controlYour quality control personnel did not perform required operations for the production and process control system. Specifically, ***
1594421 CFR 111.105(i)3QC - required operations master manufacturing/batch recordsYour quality control personnel did not perform required operations for the [master manufacturing record] [batch record] [manufacturing operations]. Specifically, ***
1596321 CFR 111.113(b)(2)3Quality control - reject; specification not metYour quality control personnel did not reject a [component] [dietary supplement] [package] [label] when an established specification was not met. Specifically, ***
1596521 CFR 111.1173Quality control operations - equipment, instruments, controlYou do not have quality control operations for [equipment] [instruments] [controls]. Specifically, ***
1597621 CFR 111.1233Quality control operations - master, batch, manufacturingYou do not have quality control operations required for the [master manufacturing record] [batch production record] [manufacturing operations]. Specifically, ***
1597721 CFR 111.123(a)(1)3QC operations - master manufacturing record, modificationsYour quality control operations did not include reviewing and approving [master manufacturing records] [modifications to the master manufacturing records]. Specifically, ***
1597821 CFR 111.123(a)(2)3Quality control operations - batch production recordsYour quality control operations did not include reviewing and approving all batch production-related records. Specifically, ***
1598321 CFR 111.123(a)(7)3Quality control operations - finished batch, specificationsYour quality control operations did not include determining whether each finished batch conforms to established product specifications. Specifically, ***
1600021 CFR 111.1303Quality control operations - returned dietary supplementYou do not have quality control operations for returned dietary supplements. Specifically, ***
1605221 CFR 111.5303Returned dietary supplement - investigationYou did not conduct an investigation of your manufacturing processes, and of each other batch implicated when a dietary supplement was returned, to determine compliance with specifications. Specifically, ***
1606621 CFR 111.35(b)(1)(i)3Written procedures -instruments, controls; calibratingYou did not make and keep written procedures for calibrating instruments or controls that you use in [manufacturing] [testing] a component or dietary supplement. Specifically, ***
1606721 CFR 111.35(b)(1)(ii)3Procedures - equipment; calibrating, inspecting, checkingYou did not make and keep written procedures for [calibrating] [inspecting] [checking] automated, mechanical, or electronic equipment. Specifically, ***
1606821 CFR 111.35(b)(1)(iii)3Equipment, utensils; maintaining, cleaning, sanitizingYou did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] equipment and utensils that are used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
1607121 CFR 111.35(b)(3)3Documentation - instruments, controls; calibrationsYou did not make and keep documentation of calibrations for instruments or controls that you use in manufacturing or testing a component or dietary supplement. Specifically, ***
1613821 CFR 118.4(c)(1)3Monitoring for rodentsThe presence of rodents is not monitored by appropriate monitoring methods. Specifically,***
1613921 CFR 118.4(c)(1)3Satisfactory rodent control methodsWhen your monitoring indicated unacceptable rodent activity within a poultry house, appropriate methods were not used to achieve satisfactory rodent control. Specifically,***
1615021 CFR 118.4(e)3Eggs to be processed as table eggsEggs intended to be processed as table eggs [were not held and transported as required at or below 45 deg. F] [were held at room temperature for more than 36 hours just prior to processing]. Specifically,***
1615721 CFR 118.5(b)(1)3SE testing 4 to 6 weeks after each molting processYou did not perform environmental testing for SE 4 to 6 weeks after the end of the molting process each time a flock or group within the flock was molted. Specifically***
1619621 CFR 118.10(a)(3)(v)3Sampling procedures documentationYou did not maintain records documenting compliance with environmental and egg sampling procedures. Specifically,***
1620721 CFR 118.10(b)(4)3Data and information re: compliance activitiesData and information reflecting compliance activities [is not entered on records at the time the activity is performed or observed] [does not indicate the actual values]. Specifically***
104021 CFR 113.102OperatorsOperators of [processing systems] [retorts] [aseptic processing systems] [product formulating systems] are not under the operating supervision of a person that has attended and satisfactorily completed, a school approved by the Commissioner. Specifically, ***
106021 CFR 123.11(a)2SSOP(S)You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP). Specifically, ***
118821 CFR 110.37(c)2Sewage disposalFailure to dispose of sewage into an adequate sewerage system or by other adequate means. Specifically, ***
130021 CFR 113.81(c)2FillThe filling of containers is not controlled to ensure that the filling requirements specified in the scheduled process are met. Specifically, ***
130321 CFR 113.81(f)2Critical 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, ***
132421 CFR 113.100(d)2Distribution recordDistribution records are not maintained to identify the initial distribution of the finished product. Specifically, ***
148621 CFR 113.87(b)2System not establishedA system of traffic control to prevent unretorted product from bypassing the retort system has not been established. Specifically, ***
150121 CFR 113.892Evaluation recordsNo records were made of the [procedures] [results] of the evaluation done by a process authority following a deviation from the scheduled process. Specifically, ***
153121 CFR 113.100(a)(6)2Water activityForms used in recording specific processing and production information for food preservation methods such as water activity in conjunction with thermal processing lack [product formulation] [scheduled processes used] [thermal process] [associated and other critical factors] [results of water activity determinations]. Specifically, ***
156321 CFR 110.35(d)(1)2Low-moisture food requirementsFood contact surfaces used for [manufacturing] [holding] low-moisture food were [wet] [insanitary] at time of use. Specifically, ***
164921 CFR 113.40(a)(1)2Scale and rangeThe mercury-in-glass thermometer [had divisions not readable to 1 degree F] [had a temperature range that exceeded 17 degrees per inch of graduated scale]. Specifically, ***
165721 CFR 113.40(a)(1)2Thermometer bleeder sizeExternal wells or pipes for mercury-in-glass thermometer bulbs were not equipped with 1/16 inch or larger bleeders.   Specifically, ***
170621 CFR 110.80(b)(10)2Mechanical manufacturing controlFailure to perform mechanical manufacturing steps so as to protect food against contamination. Specifically, ***
173121 CFR 113.40(a)(2)2Presence and accuracyEach retort did not have an accurate temperature-recording device.    Specifically, ***
173221 CFR 113.40(a)(2)2RangeGraduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of the processing temperature. Specifically, ***
173321 CFR 113.40(a)(2)2ScaleThe working scale of the temperature-recording device chart was more than 55 degrees F per inch, within a range of 20 degrees F of the processing temperature. Specifically, ***
175121 CFR 113.40(a)(8)2Size, fully openBleeders were [smaller than 1/8-inch] [not wide open during the entire process] [not open during come-up-time]. Specifically, ***
175221 CFR 113.40(a)(8)2Location - from endsBleeders on horizontal retorts are not installed [approximately one foot from the outermost end at both ends of the retort] [on top of the retort]. Specifically, ***
180621 CFR 129.80(b)(1)2Records of mechanical washersYou do not keep records of [inspection and conditions found] [physical maintenance] [performance] for mechanical washers. Specifically, ***
185521 CFR 113.40(a)(12)2InstallationVents are not installed so as to provide complete removal of air from a retort before the process start time. Specifically, ***
194421 CFR 129.80(d)2Sanitizing operations inadequateSanitizing operations are not adequate to effect sanitation of the intended product water-contact surfaces and critical areas. They do not meet the minimum times and intensities required by the regulations. Specifically, ***
196221 CFR 129.80(h)2Two year requirementYou did not retain at the plant required records for at least 2 years. Specifically, ***
211521 CFR 113.40(b)(8)2Drain valveFailure to install a [nonclogging] [water tight] drain valve [with screened openings]. Specifically, ***
215421 CFR 113.40(b)(2)2Unauthorized adjustmentThere was no means to prevent unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
227321 CFR 129.80(g)2Representative samplesSamples for [bacteriological] [chemical] [physical] [radiological] analysis are not primary containers or unit packages from a batch or segment of a continuous run for each type of bottled drinking water. Specifically, ***
238721 CFR 110.80(a)(1)2Washing and cleaningFailure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination. Specifically, ***
239121 CFR 110.80(a)(6)2Thawed appropriatelyFailure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated. Specifically, ***
309121 CFR 114.100(e)2RetentionRequired 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, ***
364821 CFR 110.20(a)(4)2Neighboring groundsFailure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control. Specifically, ***
370921 CFR 110.80(a)(1)2Inspection 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, ***
371021 CFR 110.80(b)(16)2Ice manufacturingIce in contact with food has been made from water which is [unsafe] [of inadequate sanitary quality]. Specifically, ***
386321 CFR 113.60(a)(1)2Frequency of teardown examinations (S)Teardown examinations of double seam cans (and recording of the results) were performed at intervals exceeding four hours. Specifically, ***
386621 CFR 113.60(a)(1)(i)(a)2Required 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, ***
387021 CFR 113.60(a)(2)2Glass containers, capper efficiency checkFailure to measure the cold water vacuum of the glass container capper before actual filling operations. Specifically, ***
387621 CFR 113.60(c)2Coding - 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, ***
388521 CFR 113.87(c)2IT of cans in water filled retortsFailure to assure that the initial temperature of cans exposed to water during filling or operating of the retort was not lower than the initial temperature specified in the scheduled process. Specifically, ***
388721 CFR 113.892Methods 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, ***
446521 CFR 114.100(c)2Process deviations - action to rectifyFailure to record the action taken to rectify a departure from a scheduled process. Specifically, ***
451821 CFR 108.35(c)(2)(ii)2Process change - increaseFailure to file with FDA changes in previously filed scheduled processes, where processing parameters were higher or longer, when the processes became regularly scheduled. Specifically, ***
452821 CFR 108.35(c)(2)(ii)2Process change recordingFor an intentional change in a previously filed scheduled process, substantiation was not [promptly recorded] [verified in writing by the authority] [placed in your files for review by FDA]. Specifically, ***
992921 CFR 120.12(b)(4)2Records - information not entered when observedProcessing and other information is not [always] entered on your records at the time it is observed. Specifically, ***
993321 CFR 120.6(b)2GMP correction - timelyYou do not [always] correct deficiencies from good manufacturing practice in a timely manner. Specifically, ***
993621 CFR 120.7(a)2Hazard analysis - written - 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, ***
995321 CFR 120.11(a)(1)(iv)(A)2CCP 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, ***
1270321 CFR 129.80(a)2Product samplesYou do not take product water samples after processing and prior to bottling. Specifically, ***
1270921 CFR 129.80(c)2Records of cleaning/sanitizing solutionsYou do not maintain records of [sampling] [testing] of cleaning and sanitizing solutions. Specifically, ***
1273321 CFR 120.11(a)(1)(iv)(C)2Calibration, 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, ***
1539721 CFR 111.10(b)(7)2Personal belongingsYour personnel stored clothing or other personal belongings in areas where [components, dietary supplements, or contact surfaces are exposed] [contact surfaces are washed]. Specifically, ***
1540321 CFR 111.12(b)2Personnel - quality control operations; responsibilitiesThe personnel you identified to perform quality control operations do not have distinct and separate responsibilities related to performing such operations from those responsibilities that the personnel otherwise have when not performing such operations. Specifically, ***
1540521 CFR 111.13(a)2Supervisor - qualifiedYou have not assigned qualified personnel to supervise the [manufacturing] [packaging] [labeling] [holding] of dietary supplements]. Specifically, ***
1542821 CFR 111.15(h)2Bathrooms - cleanYour bathrooms [were not clean] [were a potential source of contamination to components, dietary supplements, or contact surfaces]. Specifically, ***
1543321 CFR 111.15(d)(1)2Animals and pests in facilityYou allowed [animals] [pests] in your physical plant. Specifically, ***
1544421 CFR 111.15(c)(1)2Cleaning compoundsYou did not use cleaning compounds that [are free from microorganisms of public health significance] [are safe and adequate under the conditions of use]. Specifically, ***
1545621 CFR 111.20(b)2Physical plant - space; equipment, materialsYour physical plant did not have adequate space for the orderly placement of equipment and holding of materials as necessary [for maintenance, cleaning, and sanitizing operations] [to prevent contamination and mix-ups of components and dietary supplements]. Specifically, ***
1546221 CFR 111.20(d)(1)(iv)2Physical plant - temperature, humidity controlsYour physical plant did not have equipment that controls temperature and humidity when it is necessary to ensure the quality of the dietary supplement. Specifically, ***
1546321 CFR 111.20(d)(1)(v)2Physical plant - aisles, working spacesYour physical plant did not have aisles or working spaces between equipment and walls that are [adequately unobstructed] [of adequate width] to permit all persons to perform their duties and to protect against contamination of components, dietary supplements, or contact surfaces with clothing or personal contact. Specifically, ***
1553421 CFR 111.255(c)2Batch record - each stepYou did not perform each step in the production of a batch, according to the master production record. Specifically, ***
1554021 CFR 111.260(a)(2)(i)2Batch record - control number, each lotYour batch production records did not include the batch, lot, or control number of each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement. Specifically, ***
1555221 CFR 111.260(j)(2)2Batch record - initials; each stepYour batch production records did not include initials of the persons performing each step. Specifically, ***
1555521 CFR 111.260(j)(2)(iii)2Batch record - initials; componentYour batch production records did not include the initials of the person responsible for adding a component to the batch. Specifically, ***
1556921 CFR 111.260(n)2Batch record - reprocessingYour batch production records did not include documentation of reprocessing. Specifically, ***
1557921 CFR 111.155(c)(1)2Components - representative samplesYou did not collect representative samples of components while the components were quarantined. Specifically, ***
1558521 CFR 111.155(d)(2)2Components - unique identifierYou did not use a unique identifier whenever you recorded the disposition of [each unique lot within each unique shipment of components that you received] [each lot of components that you produced]. Specifically, ***
1559721 CFR 111.160(c)(3)2Labels - quality control; approve, releaseYour quality control personnel did not approve labels for use in the manufacture of a dietary supplement and release them from quarantine. Specifically, ***
1559921 CFR 111.160(d)(1)2Labels - identifyYou did not identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the labels] [the status of the labels] [the dietary supplement that you distributed]. Specifically, ***
1561821 CFR 111.180(b)(1)2Written procedures - componentsYou did not make and keep written procedures for fulfilling the requirements that apply to components of dietary supplements. Specifically, ***
1566921 CFR 111.310(c)2Laboratory facilities -dietary supplement specificationsYou did not use adequate laboratory facilities to perform [testing] [examinations] necessary to determine whether your dietary supplements met specifications. Specifically, ***
1567321 CFR 111.315(a)2Criteria for establishing specificationsYou did not [establish] [follow] laboratory control processes for use of criteria for establishing appropriate specifications. Specifically, ***
1569621 CFR 111.315(e)2Examination, testing; established criteriaYou did not [establish] [follow] laboratory control processes for use of test methods and examinations in accordance with established criteria. Specifically, ***
1572821 CFR 111.365(d)2Chemical,microbiological,other test-contaminated componentsYou did not perform chemical, microbiological, or other testing, as necessary to prevent the use of contaminated components. Specifically, ***
1573921 CFR 111.210(h)(3)(ii)(B)2Components; add, verifyThe specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person to add and another person to verify the addition of the components. Specifically, ***
1574221 CFR 111.210(h)(3)2Specific actions; packaged, labeledThe written instructions in your master manufacturing record did not include specific actions to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Specifically, ***
1577421 CFR 111.415(f)(1)2Batch-lot,control number packaged, labeled dietary supplemenYou did not assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement. Specifically, ***
1580121 CFR 111.560(b)2Quality control, review, approve; investigate, follow-upYour quality control personnel did not [review and approve decisions about whether to investigate a product complaint] [review and approve the findings and follow-up action of an investigation]. Specifically, ***
1580821 CFR 111.570(a)2Records - product complaints: readily availableYou did not have records or copies of records required for product complaints readily available during the required retention period for inspection and copying by FDA when requested. Specifically, ***
1584221 CFR 111.70(f)2Specifications - product received for packaging, labelingYou did not establish specifications to [sufficiently] assure that the product you received for packaging or labeling as a dietary supplement is adequately identified and is consistent with your purchase order. Specifically, ***
1584721 CFR 111.732Specifications met - component identityYou did not determine whether you met identity specifications established for components. Specifically, ***
1584821 CFR 111.732Specifications met - component purity, strength, compositionYou did not determine whether you met established component specifications established to ensure the [purity] [strength] [composition] of dietary supplements manufactured using the components. Specifically, ***
1585021 CFR 111.732Specifications met in-process purity, strength, compositionYou did not determine whether you met in-process specifications to ensure the [purity] [strength] [composition] of the dietary supplements. Specifically, ***
1586721 CFR 111.75(b)(1)2Specifications met, in-process - quality finished batchYou did not monitor the in-process points, steps, or stages, where control is necessary to ensure that the quality of the finished batch of dietary supplement, to determine whether the in-process specifications are met. Specifically, ***
1586821 CFR 111.75(b)(2)2Specifications met - deviation, unanticipated occurrenceYou did not monitor the in-process points, steps, or stages to detect any deviation or unanticipated occurrence that may result in a failure to meet specifications. Specifically, ***
1588621 CFR 111.77(b)2Specifications not met - identity; component, rejectYour quality control personnel did not reject a component that did not meet an identity specification. Specifically, ***
1589021 CFR 111.80(a)2Components packaging, labels usedYou did not collect representative samples of each unique lot of [components] [packaging] [labels] that you used to determine whether the [components] [packaging] [labels] meet[s] established specifications. Specifically, ***
1590121 CFR 111.83(b)(3)2Reserve sample - retainedYou did not retain reserve samples for the required time. Specifically, ***
1590821 CFR 111.90(b)(1)2Reprocessed, dietary supplement - no material reviewYou reprocessed a dietary supplement for which quality control personnel did not [conduct a material review] [make a disposition decision to approve the reprocessing]. Specifically, ***
1592221 CFR 111.95(b)(3)2Documentation - ensure specifications metYou did not make and keep documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for [identity][ purity][ strength][ composition][ limits on contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement]. Specifically, ***
1595821 CFR 111.113(a)(5)2QC returned dietary supplement; material review, dispositionYour quality control personnel did not conduct a material review and make a disposition decision when a dietary supplement was returned. Specifically, ***
1596921 CFR 111.117(d)2Quality control operations - equipment functionsYour quality control operations did not include reviewing and approving controls to ensure that [automated] [mechanical] [electronic] equipment functions according to [its] [their] intended use. Specifically, ***
1597021 CFR 111.1202Quality control operations - components, packaging, labelsYou do not have quality control operations for [components] [packaging] [labels] before use in the manufacture of a dietary supplement. Specifically, ***
1599521 CFR 111.127(d)2QC operations - packaged, labeled; specificationsYour quality control operations did not include determining whether the finished [packaged] [labeled] dietary supplement conforms to established specifications. Specifically, ***
1602021 CFR 111.140 (b)(3)(ii)   2Material review, disposition, follow-up; investigationYour documentation of your material review and disposition decision and follow-up did not include a description of your investigation into the cause of the deviation from the specification or of the unanticipated occurrence. Specifically, ***
1603821 CFR 111.605(b)2Records - original, true copiesYou did not keep original records, true copies, or electronic records. Specifically, ***
1603921 CFR 111.605(c)2Records - electronicYour electronic records do not comply with the electronic records requirements. Specifically, ***
1606521 CFR 111.35(b)(1)2Written procedures - equipment, utensils; make, keepYou did not make and keep written procedures for fulfilling the requirements for equipment and utensils. Specifically, ***
1607221 CFR 111.35(b)(3)2Instruments, controls; calibrate date, reference std, methodYour calibration documentation did not [identify the instrument or control calibrated] [provide the date of calibration] [identify the reference standard used] [include the certification of accuracy of the known reference standard] [include a history of recertification of accuracy of a known reference standard] [identify the calibration method used] [include appropriate limits for accuracy and precision] [provide the calibration reading or readings found] [identify the recalibration method used] [identify the reading or readings of recalibration found if the accuracy or precision limits were not met] [include the initials of the person who performed the calibration or recalibration]. Specifically, ***
1608321 CFR 111.35(b)(6)2Documentation - equipment functions; intended useYou did not make and keep documentation of the controls you use to ensure that equipment functions according to its intended use. Specifically, ***
1613321 CFR 118.4(b)(2)2Cross contamination from equipmentYou do not maintain practices that will protect against cross contamination when equipment is moved among poultry houses. Specifically,***
1614921 CFR 118.4(e)2Egg transport temperature/timeEggs were not [held ] [transported] at or below 45 deg. F beginning 36 hours after time of lay. Specifically,***
1617121 CFR 118.7(a)2Environmental testAn environmental test for SE was not done for each poultry house as required. Specifically,***
1617221 CFR 118.7(a)2Plan appropriate to layoutThe poultry house environmental sampling plan was not appropriate to the poultry house layout. Specifically,***
1618921 CFR 118.10(c)2Records retention timeAll records are not retained for 1 year after the flock to which they pertain has been taken permanently out of production. Specifically,***
93921 CFR 123.9(f)1Computerized recordsYour computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures. Specifically, ***
97221 CFR 123.8(a)(1)1Modification HACCP planYou did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate. 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, ***
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, ***
124521 CFR 113.81(a)1Raw ingredientsThere was no means to assure that raw materials and ingredients susceptible to microbiological contamination were suitable for use in processing low-acid food. Specifically, ***
127621 CFR 129.20(c)1Adequate ventilationThe ventilation in the [processing room] [bottling room] [container washing and sanitizing area] is not adequate to minimize condensation. 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, ***
128621 CFR 129.35(a)1Approved sourcesThe [product] [operations] water [supply is] [supplies are] not from an approved source. Specifically, ***
129421 CFR 110.20(b)(3)1Outdoor fermentationProper precautions to protect food in outdoor bulk fermentation vessels cannot be taken because of deficiencies in plant [construction] [design]. 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, ***
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, ***
135921 CFR 129.35(a)(3)(i)1Maintaining sample & analysis recordsYou do not maintain records on file at the plant pertaining to [approval of the source water by government agencies] [sampling and analyses for which you are responsible]. Specifically, ***
137921 CFR 129.35(a)(4)(iv)1Compliance with standardsFinished bottled water does not comply with bottled water quality standards. Specifically, ***
142321 CFR 129.37(d)1Containers kept sanitaryYou do not [fill] [cap] [close] [seal] [package] containers in a sanitary manner so as to preclude contamination of the bottled drinking water. Specifically, ***
145321 CFR 129.40(a)(1)1Suitability - equipment and utensilsNot all plant equipment and utensils are suitable for their intended use. Specifically, ***
147321 CFR 113.831Scientific methods not performedNo acceptable scientific methods of establishing heat sterilization processes or procedures recognized by competent processing authorities were used in the determination of the scheduled process. Specifically, ***NOTE: CFSAN CONCURRENCE REQUIRED.
148421 CFR 113.87(a)1Vent not postedRetort venting procedures for each product and container size were not [posted in a conspicuous place near the processing equipment] [readily available to the retort or processing system operator] [readily available to FDA investigators]. Specifically, ***
148821 CFR 113.87(b)1Visual checks not done/recordedA visual check of the heat-sensitive indicator was not done to ensure that containers had been retorted . 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 ***
159521 CFR 110.37(b)(1)1Sufficient 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, ***
164521 CFR 113.100(c)1Records review infrequent / not doneWritten records of all container closure examinations are [not reviewed by management] [not reviewed by management with sufficient frequency] to ensure that the containers are hermetically sealed. 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, ***
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, ***
173921 CFR 113.40(a)(2)1InstallationThe temperature-recording device bulb was not installed in the retort shell or in a well attached to the retort shell. Specifically, ***
174321 CFR 113.40(a)(5)1Inadequate sizeThe steam inlet was not large enough to provide for sufficient steam for proper operation of the retort. Specifically, ***
175421 CFR 113.40(a)(8)1Location - separationBleeders on horizontal retorts are installed more than eight feet apart. Specifically, ***
175621 CFR 113.40(a)(8)1Condensate bleeder - bottom vented retortFailure to install a bleeder to remove condensate in the bottom of a retort with top mounted steam inlets and bottom venting. Specifically, ***
175721 CFR 113.40(a)(8)1ObservableFailure to install bleeders so that the operator can observe that they are functioning properly. Specifically, ***
181221 CFR 129.80(c)1Testing of cleaning/sanitizing solutionsYou do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance. Specifically, ***
185421 CFR 113.40(a)(9)1Container positioningThe positioning of containers in a retort was not in accordance with the scheduled process. Specifically, ***
186521 CFR 113.40(a)(12)1Short ventTiming of a process began before the retort [was properly vented] [processing temperature was reached]. 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, ***
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, ***
206521 CFR 123.28(c)1Shellstock 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, ***
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, ***
210221 CFR 113.40(a)(13)(i)1Maximum weightThe [maximum fill-in weight] [drain weight] specified in the scheduled process is not [measured] [recorded] at intervals of sufficient frequency to ensure that the weight of the product is within limits specified in the scheduled process. Specifically, ***
214421 CFR 113.40(b)(1)1Thermometer calibrationMercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon installation] [at least once a year] [as frequently as necessary]. Specifically, ***
214921 CFR 113.40(b)(1)1Not used as referenceA mercury-in-glass thermometer was not the reference instrument used for indicating processing temperatures.   Specifically, ***
215321 CFR 113.40(b)(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, ***
215621 CFR 113.40(b)(2)1Placement of bulb in vrtcl retorts w/ recorder-controllersTemperature recorder-controller bulb for vertical still retort [not located at the bottom of the retort below the lowest crate rest] [located where steam is allowed to strike the bulb directly]. Specifically, ***
216621 CFR 113.40(b)(7)1Flexible containersDividers, racks, trays or other devices for positioning flexible containers do not ensure even circulation of the heating medium around all containers in the retort. Specifically, ***
216721 CFR 113.40(b)(9)1No indicatorThere is no means to determine the water level in a retort during operations. 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, ***
232121 CFR 113.40(c)(2)1Unauthorized adjustmentThere was no means of preventing unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
232921 CFR 113.40(c)(5)1Size, fully openBleeders are [smaller than 1/8-inch] [not wide open during the entire process] [not open during come-up-time]. Specifically, ***
246121 CFR 113.40(d)(2)1Presence and accuracyEach retort did not have an accurate temperature-recording device. Specifically, ***
246421 CFR 113.40(d)(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, ***
247621 CFR 113.40(d)(6)1Heat distributionHeat distribution data or documentary proof from the retort manufacturer or process authority was not available to demonstrate that adequate venting is achieved in the retort. Specifically, ***
249321 CFR 113.40(e)(1)1Scale and rangeThe mercury-in-glass thermometer [lacked divisions readable to 1 degree F] [had a temperature range that exceeded 17 degrees per inch of graduated scale]. Specifically, ***
249821 CFR 113.40(e)(1)1Not used as referenceThe mercury-in-glass thermometer was not the reference instrument used for indicating processing temperatures.   Specifically, ***
250021 CFR 113.40(e)(2)1RangeGraduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of the processing temperature. Specifically, ***
250321 CFR 113.40(e)(2)1Unauthorized adjustmentThere was no means of preventing unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
253821 CFR 113.40(f)(2)1Unauthorized adjustmentThere was no means of preventing unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
283721 CFR 113.40(g)(4)1Critical factorsCritical factors were not [measured] [recorded on the processing record] at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process. Specifically, ***
283821 CFR 113.40(g)(1)(i)(a)1Presence and accuracyEach product sterilizer does not have a mercury-in glass thermometer (MIG) or equivalent temperature-indicating device. Specifically, ***
283921 CFR 113.40(g)(1)(i)(a)1Scale and rangeThe mercury-in-glass thermometer [lacked divisions readable to 1 degree F] [had a temperature range that exceeded 17 degrees per inch of graduated scale]. Specifically, ***
284021 CFR 113.40(g)(1)(i)(a)1CalibrationThermometers and temperature indicating devices were not tested against a known accurate standard thermometer [upon installation] [at least once a year] [as frequently as necessary]. Specifically, ***
284421 CFR 113.40(g)(1)(i)(b)1Presence and accuracyEach product sterilizer was not equipped with an accurate temperature-recording device. Specifically, ***
284821 CFR 113.40(g)(1)(i)(b)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] a known accurate mercury-in-glass thermometer. Specifically, ***
289021 CFR 113.40(g)(2)(i)(a)1Automatic recording devicesAutomatic recording devices were not used to record [sterilization media flow rates] [temperature] [concentration] [factors specified in the scheduled process] for container sterilizing, filling, and closing operations.   Specifically, ***
289321 CFR 113.40(g)(2)(i)(b)1Cycle rateNo method is used to ensure the sterilization cycle operates at the rate specified in the scheduled process. Specifically, ***
309321 CFR 114.891Process deviation evaluation - recordFailure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations]. Specifically, ***
364421 CFR 110.10(b)(5)1Impermeable (S)Gloves used for food handling are not impermeable. Specifically, ***
364921 CFR 110.35(d)(1)1Dry and sanitaryFailure to keep food-contact surfaces used in the [manufacture] [holding] of low-moisture food in a dry, sanitary condition at the time of use. Specifically, ***
366321 CFR 110.40(e)1Lack 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, ***
370821 CFR 110.80(a)(1)1Water quality -- wash, rinse, convey foodWater [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality]. Specifically, ***
377121 CFR 113.40(a)(7)1Location of steam spreader perforations (S)Perforations in the steam spreader along the bottom of the retort are not located along the top 90 degrees of the steam spreader. Specifically, ***
377421 CFR 113.40(a)(8)1Bleeders, alternate locationsBleeders are installed on a still retort in locations other than those listed in 21 CFR 113.40(a)(8), and there are no heat distribution data to show that adequate removal of air and circulation of steam is accomplished. 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, ***
385921 CFR 113.60(a)1Frequency of visual closure examinations (S)Failure to record visual container closure observations [at intervals of thirty (30) minutes or less] [following a jam in a closing machine] [after closing machine adjustment] [after startup following a prolonged shutdown]. Specifically, ***
386021 CFR 113.60(a)1Pertinent observationsFailure to record all pertinent visual closure observations. Specifically, ***
386921 CFR 113.60(a)(1)(ii)1Method of taking seam measurements (micrometer)Failure to measure can double seam characteristics using a  micrometer at three different points approximately 120 degrees apart, excluding the side seam. Specifically, ***
387321 CFR 113.60(a)(3)1Records of closure examinations other than cans or glassFailure to maintain records of the results of inspections and tests performed on closing machines. Specifically, ***
406221 CFR 113.100(a)1Critical 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, ***
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, ***
406921 CFR 113.40(b)(13)1Retort configurationFailure to have data on file which demonstrates that the heat distribution is adequate for retort installations which deviate from the diagrams in 21 CFR 113.40(b)(13). Specifically, ***
441921 CFR 110.10(c)1Level 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, ***
447721 CFR 108.25(d)1Reporting to FDAFailure to promptly notify the FDA of any instance of [spoilage] [process deviation] [contamination with microorganisms] which represents a potential danger to public health, prior to distribution. Specifically, ***
979221 CFR 106.30(b)(3)1Stability analysisFailure to conduct stability analysis on representative samples of finished product batches. Specifically, ***
991721 CFR 120.10(c)1Corrective action documentationYou do not have records that [fully] document corrective actions that were taken. Specifically, ***
993821 CFR 120.7(d)1Hazard analysis - evaluation of effect on safety (S)You did not evaluate [product ingredients] [processing procedures] [packaging] [storage] [intended use] [facility and equipment function and design] [plant sanitation, including employee hygiene] to determine the potential effect on the safety of the finished food for the intended consumer. Specifically, ***
995921 CFR 120.12(d)(1)1Record retention - generalYou do not retain [all of] the required records at your facility for the required time period. Specifically, ***
996321 CFR 120.24(c)1Process controls - exempt process, single facilityYou do not process and perform final product packaging in a single facility operating under current good manufacturing practices. Specifically, ***
996421 CFR 120.251Finished product not analyzed for E.coliYou do not [always] analyze your finished juice product for biotype I Escherichia coli. Specifically, ***
996521 CFR 120.25(b)1Process verification - sampling each productYou do not [always] take samples from each juice product you produce that is subject to the requirements for Escherichia coli analysis. Specifically, ***
996921 CFR 120.25(a)1Process verification - sample sizeYou did not [randomly] take the required samples for Escherichia coli testing for the amount of juice produced [from finished consumer packages]. Specifically, ***
1270421 CFR 129.80(a)1Analytical frequencyYou do not analyze product water samples as often as necessary to assure uniformity and effectiveness of the treatment processes performed by the plant. Specifically, ***
1270721 CFR 129.80(g)(3)1Records of analysesFor analyses of bottled water, you do not maintain records of [date of sampling] [type of product] [production code] [results]. Specifically, ***
1271721 CFR 129.80(h)1CertificatesYou did not retain at the plant current certificates or notifications of approval issued by the government agency or agencies approving the source and supply of product water and operations water. Specifically, ***
1273621 CFR 120.12(e)1Records - review and copyingYou did not make all required records available for review and copying at reasonable times. Specifically, ***
1275121 CFR 120.8(b)(7)1HACCP plan - recordkeeping systemYour HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical control points. Specifically, ***
1275321 CFR 120.11(a)(1)(iv)(B)1CA record review adequacyYour review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions were taken]. Specifically, ***
1275421 CFR 120.11(a)(1)(iv)(C)1Calibration, testing - record review adequacyYour 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, ***
1500121 CFR 113.60(a)1Corrective actionsWhen a teardown examination revealed gross closure defects, [adequate] corrective action was not taken. Specifically, ***
1530921 CFR 70.201Color additive packagingStraight color was not packaged in a container that [prevented changes in composition] [was sealed so that it could not be opened without breaking the seal]. Specifically, ***
1531021 CFR 70.251Color additive labelingColor additive was not labeled with [the name of the straight color] [the name of each ingredient comprising the color additive] [a statement indicating general limitations for use] [the amount of each straight color in terms of weight per unit/volume or percent by weight] [an expiration date]. Specifically, ***
15358FDCA 761(c)(1)1Timing of AE report submission (dietary supplement)An adverse event report for a dietary supplement was not submitted to the Secretary of HHS within 15 business days of receipt of the report,. Specifically, ***
1538321 CFR 111.10(a)1Personnel - health conditionYou did not take measures to prevent microbial contamination by excluding from your operations [a person] [persons] who, due to a health condition, might be a source of microbial contamination of any material, including components, dietary supplements, and contact surfaces used in the manufacture, packaging, labeling, or holding of a dietary supplement. Specifically, ***
1538921 CFR 111.10(b)(1)1Outer garmentsYour personnel did not wear outer garments in a manner that protects against contamination of components, dietary supplements or contact surfaces. Specifically, ***
1539521 CFR 111.10(b)(5)1GlovesYour personnel used gloves that were not [intact] [clean] [in a sanitary condition] [made of impermeable material]. Specifically, ***
1539621 CFR 111.10(b)(6)1Hair restraintsYour personnel did not wear [effective] hair restraints [in an effective manner]. Specifically, ***
1540021 CFR 111.12(a)1Personnel - qualified - generalYour personnel are not qualified to [manufacture] [package] [label] [hold] dietary supplements. Specifically, ***
1540621 CFR 111.13(b)1Supervisor - education, trainingEach supervisor you use is not qualified by education, training, or experience to supervise. Specifically, ***
1542321 CFR 111.15(j)1Trash disposalYou did not convey, store, and dispose of trash to [minimize development of odors] [minimize potential for the trash to attract, harbor, or become a breeding place for pests] [protect against contamination of components, dietary supplements, contact surfaces, water supplies, and grounds surrounding your physical plant] [control hazardous waste to prevent contamination of components, dietary supplements, and contact surfaces]. Specifically, ***
1542921 CFR 111.15(k)1Sanitation supervisors - assignedYou did not assign one or more employees to supervise overall sanitation. Specifically, ***
1543521 CFR 111.15(d)(3)1Insecticides, fungicidesYou used [insecticides] [fumigants] [fungicides] [rodenticides] without taking precautions to protect against the contamination of components, dietary supplements, or contact surfaces. Specifically, ***
1544121 CFR 111.15(a)(5)1Bordering groundsYour plant grounds are bordered by grounds that were not under your control and were not maintained, and you did not exercise care in your plant by inspection, extermination, or other means to exclude [pests] [dirt] [filth] [extraneous materials] that may be a source of contamination. Specifically, ***
1544721 CFR 111.15(c)(3)1Cleaning compounds and toxic materials - holdingYou did not [identify] [hold] cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces. Specifically, ***
1545521 CFR 111.20(a)1Physical plant - size, construction, designYour physical plant was not suitable in size, construction, design to facilitate [maintenance] [cleaning] [sanitizing] operations. Specifically, ***
1546021 CFR 111.20(d)(1)(ii)1Physical plant - fixtureYour [fixtures] [ducts] [pipes] were not designed and constructed so that they do not contaminate of components, dietary supplements, or contact surfaces by dripping,, leakage, or condensate. Specifically, ***
1546521 CFR 111.20(d)(2)1Air blowing equipmentAir-blowing equipment was not [located] [operated] to minimize the potential for microorganisms or particulate matter to contaminate components, dietary supplements, or contact surfaces. Specifically, ***
1546621 CFR 111.20(c)1Physical plant - prevent mix-ups, contaminationYour physical plant did not permit the use of proper precautions to reduce the potential for mix-ups or contamination of components, dietary supplements, or contact surfaces, with microorganisms, chemicals, filth, or other extraneous material. Specifically, ***
1546921 CFR 111.20(c)(3)1Physical plant - separate areas for productsYou [did not have] [did not use] separate or defined areas of adequate size or other control systems to prevent contamination or mix-ups of components or dietary supplement by separating the [manufacturing] [packaging] [labeling] [holding] of different product types. Specifically, ***
1548221 CFR 111.23(c)1Records - waterYou did not make and keep records that show that the water you use [complies with applicable Federal, State, and local requirements] [does not contaminate the dietary supplement]. Specifically, ***
1550121 CFR 111.27(a)(3)(i)1Equipment - installed to facilitate cleaningYour equipment or utensils were not [installed] [maintained] to facilitate cleaning of [the equipment] [the utensils] [all adjacent spaces]. Specifically, ***
1550521 CFR 111.27(a)(3)(v)1Equipment - protect from contaminationYour equipment or utensils are not maintained to protect components and dietary supplements from being contaminated. Specifically, ***
1550621 CFR 111.27(a)(4)1Equipment - bonded seamsYou used equipment or utensils that do not have seams that are smoothly bonded or maintained to minimize accumulation of extraneous materials or contaminants. Specifically, ***
1550821 CFR 111.27(a)(5)(ii)1Refrigerator, freezer - alarmYour freezer, refrigerator, or other cold storage compartments that you use to hold components or dietary supplements does not have either an automated device for regulating temperature or an automated alarm system to indicate a significant temperature change. Specifically, ***
1550921 CFR 111.27(a)(6)1Instruments, controls - accurate, precise, maintainedYou used instruments or controls that were not [accurate and precise] [adequately maintained] [adequate in number for their designated uses]. Specifically, ***
1551421 CFR 111.27(d)(3)1Contact surfaces - wet processing, cleaningYou did not [clean] [sanitize] contact surfaces used for wet processing [before use] [after an interruption during which the contact surface may have become contaminated]. Specifically, ***
1552721 CFR 111.30(c)1Equipment - automated - QC checkYour quality control personnel did not periodically review routine [calibrations] [inspections] [checks] of your automated, mechanical, or electronic equipment. Specifically, ***
1552821 CFR 111.30(d)1Equipment - automated - controls, process changesYou did not [establish] [use] appropriate controls for automated, mechanical, or electronic equipment to ensure that changes [are approved by quality control personnel] [are instituted only by authorized personnel]. Specifically, ***
1553521 CFR 111.255(d)1Batch record - 1 year, 2 yearsYou did not keep batch production records for the required time period. Specifically, ***
1553921 CFR 111.260(a)(1)1Batch record - control number, finished batchYour batch production records did not include the batch, lot, or control number of the finished batch of dietary supplement. Specifically, ***
1555321 CFR 111.260(j)(2)(i)1Batch record - initials; weighingYour batch production records did not include the initials of the person responsible for weighing or measuring each component used in the batch. Specifically, ***
1556121 CFR 111.260(k)(3)1Batch record - tests, examinations; resultsYour batch production records did not include the results of any tests or examinations conducted on packaged and labeled dietary supplements or a cross-reference to the physical location of such results. Specifically, ***
1556421 CFR 111.260(l)(1)(ii)1Batch record - quality control; tests, examinationsYour batch production records did not include documentation that quality control personnel reviewed the results of tests and examinations. Specifically, ***
1556521 CFR 111.260(l)(2)1Batch record - reprocessing, repackagingYour batch production records did not include documentation that quality control personnel approved or rejected [reprocessing] [repackaging]. Specifically, ***
1556821 CFR 111.260(m)1Batch record - performanceYour batch production records did not include documentation [at the time of performance] of a required material review and disposition decision. Specifically, ***
1557121 CFR 111.1531Written procedures - packagingYou did not [establish] [follow] written procedures for the requirements for packaging received. Specifically, ***
1558421 CFR 111.155(d)(1)1Components - identify lot producedYou did not identify each lot of components that you produced in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the component] [the status of the component] [the dietary supplement that you manufactured and distributed]. Specifically, ***
1558621 CFR 111.155(e)1Components - contamination, deterioration, mixupsYou did not hold components under conditions that will [protect against contamination] [protect against deterioration] [avoid mix-ups]. Specifically, ***
1559021 CFR 111.160(c)(1)1Packaging - quarantine; samplesYou did not collect representative samples of packaging while the packaging was quarantined. Specifically, ***
1559621 CFR 111.160(c)(3)1Packaging - quality control; approve, releaseYour quality control personnel did not approve packaging for use in the manufacture of a dietary supplement and release it from quarantine. Specifically, ***
1560221 CFR 111.160(e)1Packaging, labels - mix-upsYou did not hold [packaging] [labels] under conditions that will avoid mix-ups. Specifically, ***
1560421 CFR 111.165(b)1Product received - visually examine invoice, guarantee, certYou did not visually examine the supplier's invoice, guarantee, or certification in a shipment of received product to ensure that the received product was consistent with your purchase order. Specifically, ***
1560721 CFR 111.165(c)(2)1Product received - quality control; documentation; specsYour quality control personnel did not review and approve documentation to determine whether quarantined received product meets established specifications. Specifically, ***
1561021 CFR 111.165(d)(1)1Product received - identifyYou did not identify each unique lot within each unique shipment of received product in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the received product] [the status of the received product] [the product that you packaged or labeled and distributed as a dietary supplement]. Specifically, ***
1561121 CFR 111.165(d)(2)1Product received - unique identifier, dispositionYou did not use a unique identifier when you recorded the disposition of a unique lot within a unique shipment of received product. Specifically, ***
1562021 CFR 111.180(b)(1)1Written procedures - product receivedYou did not make and keep written procedures for fulfilling the requirements that apply to product received for packaging or labeling as a dietary supplement and for distribution rather than for return to the supplier. Specifically,
1562521 CFR 111.180(b)(3)1Documentation - componentsYou did not make and keep documentation that the requirements that apply to production and process control for components of dietary supplements were met. Specifically, ***
1562721 CFR 111.180(b)(3)1Documentation - product received; packaging, labelingYou did not make and keep documentation that the requirements that apply to production and process control for product received for packaging or labeling as a dietary supplement were met. Specifically, ***
1563021 CFR 111.180(b)(3)(i)1Document - required operationThe person who performed a required operation did not document, at the time of performance, that the required operation was performed. Specifically, ***
1565021 CFR 111.465(a)1Hold - reserve samples; contamination, deteriorationYou did not hold reserve samples of dietary supplements in a manner that protects against contamination or deterioration. Specifically, ***
1565521 CFR 111.475(a)1Records - holding, distribution: 1 year, 2 yearsYou did not keep the records required for your holding and distributing operations for the required time period. Specifically, ***
1567221 CFR 111.3151Laboratory control processes - reviewed, approvedThe laboratory control processes that you established and followed were not reviewed and approved by quality control personnel. Specifically, ***
1567721 CFR 111.315(b)(1)1Sampling plans; componentsYou did not [establish] [follow] sampling plans for obtaining representative samples of components. Specifically, ***
1568321 CFR 111.315(c)1Examination, testing methods; criteria for selectingYou did not [establish] [follow] laboratory control processes for use of criteria for selecting appropriate examination and testing methods. Specifically, ***
1569521 CFR 111.315(e)1Examination, testing; established criteria, quality controlYour laboratory control processes for use of test methods and examinations in accordance with established criteria were not reviewed and approved by quality control personnel. Specifically, ***
1570921 CFR 111.325(b)(2)1Laboratory methodology followedYou did not make and keep documentation that established laboratory methodology was followed. Specifically, ***
1572521 CFR 111.365(g)1Identifying, holding - contamination, mix-upsYou did not identify and hold [components] [dietary supplements] for which a material review and disposition decision is required in a manner that protects [components] [dietary supplements] that are not under a material review against contamination and mix-ups with those that are under a material review. Specifically, ***
1572721 CFR 111.365(e)1Microorganism, decomposition - remove, destroy, preventYou did not use effective means to [remove, destroy, or prevent the growth of microorganisms] [prevent decomposition]. Specifically, ***
1573221 CFR 111.365(a)1Conditions, controls -protect; microorganisms, contaminationYou did not perform manufacturing operations under conditions and controls that protect against [the potential for growth of microorganisms] [the potential for contamination]. Specifically, ***
1574021 CFR 111.210(h)(3)(ii)(A)1Instructions; components; weight, measureThe specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person weighing or measuring and another person verifying the weight or measure of components. Specifically, ***
1574921 CFR 111.210(e)1Master manufacturing record - intentional overageYour master manufacturing record did not include a statement of intentional overage amount of a dietary ingredient. Specifically, ***
1575021 CFR 111.210(d)1Master manufacturing record - ingredients listYour master manufacturing record did not include the identity of each ingredient that will be declared on the ingredients list of the dietary supplement. Specifically, ***
1575521 CFR 111.205(c)1Master manufacturing record: readily availableYou did not have records or copies of records required for your master manufacturing records readily available during the required retention period for inspection and copying by FDA when requested. Specifically, ***
1575621 CFR 111.205(c)1Master manufacturing record: electronicYour electronic master manufacturing records do not comply with the electronic records requirements. Specifically, ***
1575821 CFR 111.205(c)1Master manufacturing record: 1 year, 2 yearsYou did not keep a master manufacturing record for the required time period. Specifically, ***
1576021 CFR 111.205(b)(1)1Master manufacturing record-specifications; packaged, labelYour master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Specifically, ***
1576521 CFR 111.430(a)1Packaging, labeling operations:originals, copies, electronicYou did not keep the records required for your packaging and labeling operations as original records, true copies, or as electronic records. Specifically, ***
1576821 CFR 111.420(c)1Repackaged, relabeled - quality control: approve, rejectsYour quality control personnel did not approve or reject each batch of [repackaged] [relabeled] dietary supplement prior to its release for distribution. Specifically, ***
1577521 CFR 111.415(e)1Dietary supplement containers - mix-upsYou did not [identify] [identify by effective means] filled dietary supplement containers that are set aside and held in unlabeled condition for future label operations, to prevent mix-ups. Specifically, ***
1577621 CFR 111.415(d)1Packaging, labeling - physical separationYou did not establish physical or spatial separation of [packaging] [label] operations from operations on other components and dietary supplements to prevent mix-ups. Specifically, ***
1577921 CFR 111.415(a)1Clean, sanitize - filling, packaging equipmentYou did not clean and sanitize [filling and packaging equipment] [utensils] [dietary supplement packaging], as appropriate. Specifically, ***
1578121 CFR 111.4151Fill, assemble, package, label - qualityYou did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a way that ensured the quality of the dietary supplement. Specifically, ***
1578721 CFR 111.410(b)1Packaging - issuance, useYou did not control the [issuance] [use] of packaging. Specifically, ***
1579921 CFR 111.560(a)(1)1Product complaint - quality control reviewA qualified person did not review a product complaint to determine whether the product complaint involves a possible failure of a dietary supplement to meet specifications or any other requirements. Specifically, ***
1580321 CFR 111.560?1Product complaint -investigate, findings, follow-upYour [review about whether to investigate a product complaint] [findings and follow-up action of an investigation performed] did not extend to all relevant batches and records. Specifically, ***
1581021 CFR 111.570(b)(2)1Record - product complaint; good manufacturing practiceYou did not make and keep a written record of every product complaint that was related to good manufacturing practice. Specifically, ***
1581421 CFR 111.570(b)(2)(ii)(C)1Record - product complaint; date received, complainantThe written record of a product complaint did not include [the date the complaint was received] [the name, address, or telephone number of the complainant]. Specifically, ***
1582321 CFR 111.60(b)1Production, in-process control system review, approvedYour production and in-process control system was not reviewed and approved by quality control personnel. Specifically, ***
1583321 CFR 111.70(c)(1)1Specifications - in-process contamination limitsYou did not establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary for limits on contamination that may adulterate or may lead to adulteration of the finished dietary supplement. Specifically, ***
1583421 CFR 111.70(c)(2)1Specifications identity, purity strength, compositionYou did not provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for [the identity] [purity] [strength] [composition]. Specifically, ***
1584121 CFR 111.70(f)1Specifications - product received for packaging, labelingYou did not establish specifications to [sufficiently] assure that the product you received for packaging or labeling as a dietary supplement is adequately identified and is consistent with your purchase order. Specifically,
1584921 CFR 111.731Specifications met - contamination limitsYou did not determine whether you met established limits on contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement. Specifically, ***
1585421 CFR 111.731Specifications met - contamination limitsYou did not determine whether you met established limits on contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement. Specifically, ***
1586521 CFR 111.75(a)(2)(ii)(D)1Re-confirm certificate of analysisYou did not periodically re-confirm the supplier's certificate of analysis for a component. Specifically, ***
1586621 CFR 111.75(a)(2)(ii)(E)1Documentation - quality control, review, approve supplierYour quality control personnel did not review and approve the documentation setting forth the basis for [qualification] [re-qualification] of a supplier of a component. Specifically, ***
1587521 CFR 111.75(d)(1)1Documentation specifications met; exempted, periodic testingYou did not document why an exempted product specification is met without verification by periodically testing the finished batch. Specifically, ***
1587821 CFR 111.75(e)1Product - visually examine, identifiedYou did not [visually examine a product that you received for packaging or labeling] [have documentation that the product you received for packaging or labeling is adequately identified and is consistent with your purchase order]. Specifically, ***
1588121 CFR 111.75(g)1Packaging, labeling - visual examinationYou did not conduct a visual examination of the [packaging] [labeling] of the finished [packaged] [labeled] dietary supplements to determine whether you [used] [applied] the specified label. Specifically, ***
1588321 CFR 111.75(i)1Corrective action planYou did not establish a corrective action plan to use when an established specification is not met. Specifically, ***
1589221 CFR 111.80(b)1Specifications - representative samples; in-process materialYou did not collect representative samples of in-process materials for each manufactured batch as specified in the master manufacturing record to determine whether the in-process materials met established specifications. Specifically, ***
1589521 CFR 111.80(e)1Specifications - representative samples; packaged, labeledYou did not collect representative samples of each lot of [packaged] [labeled] dietary supplements to determine whether the [packaging] [labeling] of the finished dietary supplements meets established specifications. Specifically, ***
1591121 CFR 111.90(b)(1)1In-process adjustment, component - no material reviewYou made an in-process adjustment to a component of a dietary supplement for which quality control personnel did not [conduct a material review] [make a disposition decision to approve the in-process adjustment]. Specifically, ***
1592321 CFR 111.95(b)(4)1Documentation - specifications met; test, examinationsYou did not make and keep documentation for why the results of tests or examinations you selected for the product specifications ensure that the dietary supplement meets all product specifications. Specifically, ***
1592421 CFR 111.95(b)(5)1Documentation - exempted product specification metYou did not make and keep documentation for why component and in-process testing, examination, monitoring or other information will ensure that an exempted product specification is met, without verification through periodic testing of the finished batch. Specifically, ***
1593121 CFR 111.1051Quality control - packaged, labeledYour quality control personnel did not ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record. Specifically, ***
1593621 CFR 111.105(e)1Quality control - verification requirements, exemptedYour quality control personnel did not review and approve the basis and documentation for why a product specification is exempted from the verification requirements. Specifically, ***
1593821 CFR 111.105(f)1Quality control - representative samplesYour quality control personnel did not ensure that required representative samples are collected. Specifically, ***
1593921 CFR 111.105(g)1Quality control - reserve samplesYour quality control personnel did not ensure that required reserve samples were collected and held. Specifically, ***
1594021 CFR 111.105(h)1Quality control - production, process controlYour quality control personnel did not determine that specifications established for the production and process control system were met. Specifically, ***
1594321 CFR 111.105(i)1QC required operations components packaging labelsYour quality control personnel did not perform required operations for [components] [packaging] [labels] before use in the manufacture of a dietary supplement. Specifically, ***
1594721 CFR 111.105(i)1Quality control - required operations product complaintsYour quality control personnel did not perform required operations for product complaints. Specifically, ***
1594821 CFR 111.1101Quality control operations - laboratory operationsYou do not have quality control operations for laboratory operations associated with the production and process control system. Specifically, ***
1595421 CFR 111.113(a)(2)1QC master manufacturing record; material review, dispositionYour quality control personnel did not conduct a material review and make a disposition decision when a batch deviated from the master manufacturing record. Specifically, ***
1595521 CFR 111.113(a)(3)1Quality control - adulteration; material review, dispositionYour quality control personnel did not conduct a material review and make a disposition decision for an unanticipated occurrence during the manufacturing operations that adulterated or may lead to adulteration of the [component] [dietary supplement] [packaging]. Specifically, ***
1596021 CFR 111.113(b)(1)1Quality control - dietary supplement; adulterationYour quality control personnel did not reject the dietary supplement when there was a deviation or unanticipated occurrence during the production and in-process control system that [resulted in] [could lead to] adulteration of the dietary supplement. Specifically, ***
1596421 CFR 111.113(c)1Document - material review, dispositionThe person who conducted a material review and made the disposition decision did not document the material review and the disposition decision [at the time of performance]. Specifically, ***
1596621 CFR 111.117(a)1Quality control operations - calibrating processesYour quality control operations did not include reviewing and approving all processes for calibrating instruments and controls. Specifically, ***
1596821 CFR 111.117(c)1Quality control operations - equipment recordsYour quality control operations did not include periodically reviewing all records for calibrations, inspections, or checks of [automated equipment] [mechanical equipment] [electronic equipment]. Specifically, ***
1597321 CFR 111.120(c)1QC operations - material review, disposition decisionYour quality control operations did not include conducting a required material review and making a required disposition decision for [components] [packaging] [labels] prior to [their] use. Specifically, ***
1599621 CFR 111.127(e)1QC ops packaging, labeling; material review, dispositionYour quality control operations for [packaging] [labeling] did not include conducting a material review and making a required disposition decision. Specifically, ***
1601021 CFR 111.140(a)1Records - QC operations: originals, copies, electronicYou did not keep the records required for your quality control operations as original records, true copies, or as electronic records. Specifically, ***
1602221 CFR 111.140(b)(3)(iv)1Material review, disposition, follow-up; identificationYour documentation of your material review and disposition decision and follow-up did not include identification of the action taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence. Specifically, ***
1603721 CFR 111.6051Records - keep: 1 year, 2 yearsYou did not keep required written records for 1 year past the shelf life date or for 2 years beyond the date of distribution of the last batch of dietary supplements associated with the records. Specifically, ***
1604821 CFR 111.5151Returned dietary supplement - destroyedYou did not destroy, or otherwise suitably dispose of, a returned dietary supplement not approved for salvaging and redistribution or not approved for reprocessing. Specifically, ***
1605921 CFR 111.535(b)(3)1Returned dietary supplement: results; testing, examinationYou did not make and keep records of the results of testing or examination conducted to determine compliance with established product specifications. Specifically, ***
1606021 CFR 111.535(b)(4)1Returned dietary supplement: reevaluation, determinationYou did not make and keep records [of documentation of the reevaluation by quality control personnel of a dietary supplement that was reprocessed] [of the determination by quality control personnel of whether the reprocessed dietary supplement met established product specifications]. Specifically, ***
1606221 CFR 111.35(a)1Records - equipment, utensils: originals, copies, electronicYou did not keep the records required for equipment and utensils as original records, true copies, or as electronic records. Specifically, ***
1606921 CFR 111.35(b)(1)(iii)1Procedures contact surfaces; maintaining, cleaning, sanitizeYou did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
1607421 CFR 111.35(b)(4)1Records - equipment; calibrations, inspections, checksYou did not make and keep written records of calibrations, inspections, or checks of automated, mechanical, or electronic equipment. Specifically, ***
1608421 CFR 111.140(b)(3)1Records - material review, follow-upYou did not make and keep documentation of the follow-up to your material review and disposition decision. Specifically, ***
1613121 CFR 118.4(b)1Transfer or introduction of SEYou have not taken [adequate] steps to assure that there is no introduction or transfer of SE into or among poultry houses. Specifically,***
1613621 CFR 118.4(b)(5)1Employees keeping birds at homeEmployees are allowed to keep birds at home. Specifically,***
1614021 CFR 118.4(c)(2)1Monitoring for fliesThe presence of flies is not monitored by appropriate monitoring methods. Specifically,***
1615421 CFR 118.5(a)(2)(i)1Positive test at 40-45 weeks - review and adjust planAn environmental test for SE at 40 to 45 weeks of age was positive, but you did not review and make any necessary adjustments to your SE prevention plan to ensure that all measures were being properly implemented. Specifically,***
1615621 CFR 118.5(b)1Environmental testing after induced molting periodEnvironmental testing of SE in a poultry house was not performed at 4 to 6 weeks after the end of the molting process which followed your inducing of a molt in a flock or a group in the flock. Specifically,***
1617421 CFR 118.7(b)(1)1Sampling and testing: the required four egg testsYou are not meeting the requirements for the four egg tests on a flock in a positive poultry house at two week intervals in that [you are not collecting and testing a minimum of 1,000 intact eggs representative of a day's production] [you are not testing the samples according to the requirements in the CFR] [you are not collecting and testing four 1,000 egg samples at 2-week intervals for a total of 4,000 eggs]. Specifically,***
1618021 CFR 118.8(b)1Method to be used, egg samplesFor testing to detect SE in egg samples, you did not have the sample testing conducted according to Chapter 5 of FDA's Bacteriological Analytical Manual (BAM), most current edition, or an equivalent method in accuracy, precision, and sensitivity in detecting SE. Specifically,***
1618321 CFR 118.91Supervisor(s) training/job experienceSupervisory personnel responsible for ensuring compliance with the SE prevention plan(s) [have not successfully completed training on SE prevention measures for egg production that is equivalent to that received under a standardized curriculum recognized by FDA] [lack qualification through appropriate job experience to administer the SE prevention measures]. Specifically,***
1619021 CFR 118.10(a)(1)1Written SE prevention planYou do not have a written SE prevention plan. Specifically,***
1620021 CFR 118.10(d)1Offsite storage of records except SE planYour written SE prevention plan was stored offsite. Specifically,***
1622821 CFR 118.11(e)(2)1Number of layers and housesYou did not submit through your registration process, [the average or usual number of layers of each house] [the number of poultry houses] on the farm. Specifically,***
17004FDCA 402(a)1Food Field ExamDuring a field examination of food products at your facility the following [was] [were] observed:

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Devices

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Devices313021 CFR 820.100(a)372Lack of or inadequate proceduresProcedures for corrective and preventive action have not been [adequately] established. Specifically, ***
1471321 CFR 820.198(a)259Lack of or inadequate complaint proceduresProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically,***
63021 CFR 803.17140Lack of Written MDR ProceduresWritten MDR procedures have not been [developed] [maintained] [implemented]. Specifically, ***
47921 CFR 820.50126Purchasing controls, Lack of or inadequate proceduresProcedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established. Specifically, ***
369621 CFR 820.100(b)115DocumentationCorrective and preventive action activities and/or results have not been [adequately] documented. Specifically, ***
328221 CFR 820.90(a)110Nonconforming product control proceduresProcedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, ***
54621 CFR 820.75(a)102Lack of or inadequate process validationA process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. Specifically, ***
310321 CFR 820.30(i)101Design changes - Lack of or Inadequate ProceduresProcedures for design change have not been [adequately] established. Specifically,***
317221 CFR 820.198(c)96Investigation 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, ***
232721 CFR 820.2291Quality audits - Lack of or inadequate proceduresProcedures for quality audits have not been [adequately] established. Specifically, ***
333121 CFR 820.18191DMR - not or inadequately maintainedA device master record has not been [adequately] maintained. Specifically, ***
235021 CFR 820.25(b)77Training - Lack of or inadequate proceduresProcedures for training and identifying training needs have not been [adequately] established. Specifically, ***
316821 CFR 820.198(a)73ComplaintsComplaint files are not [adequately] maintained. Specifically, ***
1471221 CFR 820.18467DHR - not or inadequately maintainedA device history record has not been [adequately] maintained. Specifically, ***
312521 CFR 820.80(d)65Lack of or inadequate final acceptance proceduresProcedures for finished device acceptance have not been [adequately] established. Specifically, ***
341521 CFR 820.2262Quality Audit/Reaudit - conductedQuality [audits][reaudits] have not been performed. Specifically, ***
368021 CFR 820.70(a)62Process control procedures, Lack of or inadequate proceduresProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been [adequately] established. Specifically, ***
1472221 CFR 820.4059Procedures not adequately established or maintainedDocument control procedures have not been adequately [established] [maintained]. Specifically,***
311821 CFR 820.75(a)57DocumentationProcess validation [activities] [results] have not been [documented] [approved] [adequately documented] [adequately approved]. Specifically, ***
315921 CFR 820.18457DHR contentThe device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820].
316021 CFR 820.18457Lack of or inadequate DHR proceduresProcedures for device history records have not been [adequately] established. Specifically,***
366621 CFR 820.20(c)55Management review - Lack of or inadequate proceduresProcedures for management review have not been [adequately] established. Specifically, ***
237121 CFR 820.30(a)54Design control - no proceduresProcedures for design control have not been established. Specifically, ***
323321 CFR 820.72(a)52Calibration, Inspection, etc. Procedures Lack of or InadequProcedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established. Specifically, ***
312121 CFR 820.80(b)49Lack of or inadequate receiving acceptance proceduresProcedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
310121 CFR 820.30(g)48Design validation- Lack of or inadequate proceduresProcedures for design validation have not been [adequately] established. Specifically,***
73221 CFR 803.50(a)(2)47Report 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, ***
383721 CFR 820.25(b)47Training recordsPersonnel training is not documented. Specifically, ***
367821 CFR 820.30(g)46Design Validation - Risk analysis not performed/inadequateRisk analysis [was not performed] [is inadequate] [is incomplete]. Specifically, ***
366921 CFR 820.20(c)43Management review - defined interval, sufficient frequencyManagement with executive responsibility has not reviewed the suitability and effectiveness of the quality system [at defined intervals] [with sufficient frequency]. Specifically, ***
230221 CFR 820.20(e)42Quality System ProceduresQuality system procedures and instructions have not been established. Specifically,***
312721 CFR 820.80(e)40DocumentationAcceptance activities were not [documented] [maintained as part of the device history record] [adequately documented] [adequately maintained as part of the device history record]. Specifically, ***
54121 CFR 820.70(c)38Environmental control Lack of or inadequate proceduresProcedures to control environmental conditions have not been [adequately] established. Specifically, ***
44721 CFR 820.4037Lack of procedures, or not maintainedDocument control procedures have not been [established] [maintained]. Specifically, ***
48621 CFR 820.50(a)37Evaluation of suppliers, contractors, etc., requirementsRequirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established. Specifically, ***
312021 CFR 820.80(a)37Lack of or inadequate procedures - Acceptance activitiesProcedures for acceptance activities have not been [adequately] established. Specifically,***
297421 CFR 812.110(b)36Investigator 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, ***
41921 CFR 820.20(b)34Lack of or inadequate 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, ***
312821 CFR 820.90(a)34Nonconforming product controlProducts that do not conform to specifications are not adequately controlled. Specifically, ***
53721 CFR 820.70(a)30Production processesProduction processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications. Specifically, ***
73121 CFR 803.50(a)(1)30Report 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, ***
265021 CFR 820.30(f)30Design verification - Lack of or inadequate proceduresProcedures for design verification have not been [adequately] established. Specifically,***
232821 CFR 820.2229Quality audits - auditor independenceIndividuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***
310421 CFR 820.30(j)29Design 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].
311721 CFR 820.70(i)29Software 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, ***
53921 CFR 820.70(b)28Production and Process Change Procedures, lack of or Inad.Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established. Specifically, ***
296821 CFR 812.10028Investigator non-compliance with agreement/plan/regulationsAn investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations]. Specifically, ***
337521 CFR 820.198(e)28Records of complaint investigationRecords of complaint investigations do not include required information. 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, ***
260421 CFR 820.30(e)26Design review - Lack of or inadequate proceduresProcedures for design review have not been [adequately] established. Specifically,***
405921 CFR 820.2226Quality Audits - defined intervalsQuality 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, ***
407021 CFR 820.30(g)26Design validation - documentationThe 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, ***
328521 CFR 820.90(b)(2)25Product rework procedures, Lack of or inadequate proceduresProcedures for rework of nonconforming product have not been [adequately] established. Specifically, ***
63121 CFR 803.17(a)(1)24Lack 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, ***
313221 CFR 820.12023Lack of or inadequate procedures for labelingProcedures to control labeling activities have not been [adequately] established. Specifically, ***
317021 CFR 820.198(b)23Review and evaluation for investigationNot all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
328621 CFR 820.90(b)(1)23Procedures for product review,disposition lack of/inadequateProcedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been [adequately] established. Specifically, ***
310221 CFR 820.30(h)22Design transferProcedures for design transfer have not been [adequately] established. Specifically,***
326321 CFR 820.250(b)22Sampling plansSampling plans are not [written][based on valid statistical rationale]. Specifically, ***
419121 CFR 806.10(a)(1)22Report 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, ***
320721 CFR 820.50(b)21Supplier notification of changesThere is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service. Specifically, ***
322621 CFR 820.70(g)(1)21Maintenance schedule, Lack of or inadequate scheduleSchedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established. Specifically, ***
342621 CFR 820.50(a)(1)21Documented evaluationThe evaluation of potential[suppliers] [contractors] [consultants] was not documented. Specifically, ***
343321 CFR 820.75(c)20Process changes - review, evaluation and revalidationA validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, ***
50221 CFR 820.6019Identification procedures, Lack of or inadequate proceduresProcedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately] established. Specifically, ***
319221 CFR 820.30(g)19Design validation - user needs and intended usesDesign validation did not ensure the device conforms to defined user needs and intended uses. Specifically, ***
367121 CFR 820.25(a)19PersonnelPersonnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***
367621 CFR 820.30(f)19Design verification - documentationThe 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, ***
1471621 CFR 820.30(f)19Design verification - output does not meet input requirementDesign verification does not confirm that design output meets design input requirements. Specifically, ***
297021 CFR 812.10017Investigator lack of informed consentInformed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, ***
326221 CFR 820.250(a)17Statistical techniques - Lack of or inadequate proceduresProcedures 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,***
342521 CFR 820.50(a)(1)17Evaluation and Selection, Suppliers, Contractors, etc.Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements. Specifically, ***
1471021 CFR 820.15017Lack of or inadequate procedures for storage.Procedures for the control of storage areas and stock rooms have not been [adequately] established. Specifically,***
243021 CFR 820.30(b)16Design plans - Lack of or inadequateDesign plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established. Specifically, ***
312321 CFR 820.80(c)16Lack of or inadequate In-process acceptance proceduresProcedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***
319121 CFR 820.30(g)16Design validation - production unitsThe design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents]. Specifically, ***
1472021 CFR 820.50(a)(3)16Acceptable supplier records, inadequate recordsRecords of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.
63221 CFR 803.17(a)(2)15Lack 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, ***
292821 CFR 812.4015Sponsors' 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 newinformation about an investigation] [FDA was not promptly informed of significant new information about an investigation]. Specifically, ***
320121 CFR 820.40(a)15Not approved or obsolete document retrievalDocuments that were [not approved] [obsolete] were observed at a location where they [could be] [are being] used. Specifically, ***
326921 CFR 820.80(b)15Incoming acceptance records, documentationAcceptance or rejection of incoming product was not documented. Specifically, ***
298121 CFR 812.140(a)(2)(i)14Investigator 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, ***
334521 CFR 820.200(a)14Servicing - Lack of or inadequate proceduresProcedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been [adequately] established. Specifically, ***
367721 CFR 820.30(g)14Design validation - software validation not performedValidation of device software [was not performed] [is inadequate] [is incomplete]. Specifically, ***
1471821 CFR 820.30(g)14Design validation - Risk analysisResults of the design risk analysis were not [adequately] documented. Specifically, ***
229321 CFR 820.20(d)13Quality planA quality plan has not been [adequately] established. Specifically, ***
323521 CFR 820.72(a)13Equipment control activity documentationEquipment [calibrations] [inspections] [checks][maintenance activities] have not been documented. Specifically, ***
327021 CFR 820.80(c)13DocumentationIn-process inspections, tests, or other verification activities and approvals were not documented. Specifically, ***
368621 CFR 820.90(b)(2)13Product rework documentation, DHR {see also 820.184}Rework and reevaluation activities have not been [fully] documented in the device history record. Specifically, ***
1471421 CFR 820.30(c)13Design input - Lack of or inadequate proceduresProcedures for design input have not been [adequately] established. Specifically,***
226921 CFR 820.20(a)12Quality policy and objectivesThe [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility. Specifically, ***
255721 CFR 820.30(c)12Design input documentationDesign input requirements were not [adequately] documented. Specifically, ***
311921 CFR 820.75(b)12Lack/Inad procedure-Monitoring/Control of Validated ProcesProcedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifically, ***
320621 CFR 820.50(b)12Approval, inadequate purchasing dataPurchasing 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, ***
342721 CFR 820.50(a)(2)12Supplier oversightThe type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, ***
421221 CFR 806.20(b)(4)12Justification 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,***
326421 CFR 820.250(b)11Sampling methods - Lack of or inadequate proceduresProcedures to ensure sampling methods are adequate for their intended use have not been [adequately] established. Specifically,***
405721 CFR 820.20(a)11Management ensuring quality policy is understoodManagement with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization. Specifically, ***
310821 CFR 820.70(e)10Contamination control, Lack of or inadequate 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, ***
317121 CFR 820.198(b)10Rationale documented for no investigationRecords for complaints where no investigation was made do not include required information. Specifically ***
317321 CFR 820.198(d)10Evaluation, 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, ***
320321 CFR 820.40(b)10Document change records, maintained.Records of changes to documents were not [adequately] maintained. Specifically, ***
367421 CFR 820.30(d)10Design output - documentationDesign output was not [adequately] documented before release. Specifically, ***
680021 CFR 807.2010Establishment not registeredAn establishment for which registration is required has not been registered. Specifically, ***
680321 CFR 807.20(a)10Devices not listedDevices for which listing is required have not been listed. Specifically, ***
1471121 CFR 820.160(a)10Lack of or inadequate procedures for distributionProcedures for control and distribution of finished devices have not been [adequately] established. Specifically,***
319321 CFR 820.30(g)9Design validation - simulated testingThe design was not validated under actual or simulated use conditions. Specifically, ***
326621 CFR 820.869Acceptance statusThe acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained]. Specifically, ***
366821 CFR 820.20(c)9Management review datesThe results and/or dates of management reviews are not documented. Specifically, ***
1471921 CFR 820.30(h)9Incorrect translation to production specificationsThe device design was not correctly translated into production specifications. Specifically, ***
63521 CFR 803.17(b)(1)8Info 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, ***
298421 CFR 812.140(a)(3)(i)8Investigator 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, ***
298521 CFR 812.140(a)(3)(ii)8Investigator 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, ***
314921 CFR 820.1808AvailabilityRequired 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, ***
319021 CFR 820.30(g)8Design validation acceptance criteriaAcceptance criteria were not established prior to the performance of validation activities. Specifically, ***
319921 CFR 820.40(a)8Document review, approval documentationThe documentation of approval of documents does not include [the document approval date] [the signature of the approving official]. Specifically, ***
334621 CFR 820.200(b)8Analyzing service reportService reports were not analyzed following appropriate statistical methods. Specifically, ***
343221 CFR 820.75(b)(2)8Documentation 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, ***
368321 CFR 820.70(g)8Equipment Installation, Placement, Specified RequirementsThe [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, ***
1471521 CFR 820.30(d)8Design output - Lack of or inadequate proceduresProcedures for design output have not been [adequately] established. Specifically,***
45421 CFR 820.40(a)7Document review, approval by designated individualDocuments were [not reviewed] [not approved] by designated individual(s) prior to issuance . Specifically, ***
81221 CFR 803.567Submission 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, ***
243121 CFR 820.30(b)7Design plans- updatedDesign plans were not [reviewed] [updated] [approved] as design and development evolves. Specifically, ***
331321 CFR 820.120(d)7Records, 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, ***
337221 CFR 820.198(d)7Records of MDR InvestigationInvestigation records of MDR reportable complaints do not include required information. Specifically ***
340921 CFR 820.200(d)7Service reportsService reports [are not documented] [do not include the required information]. Specifically, ***
298021 CFR 812.140(a)(1)6Investigator 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, ***
323121 CFR 820.70(i)6Documentation 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, ***
323221 CFR 820.72(a)6Equipment suitability & capabilityCertain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results]. Specifically, ***
419221 CFR 806.10(a)(2)6Report 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, ***
420821 CFR 806.20(a)6Records not keptThere is no record maintained of a correction or removal action that was not required to be reported to FDA. Specifically,***
1450721 CFR 812.140(a)(3)(ii)6Investigator adverse effect records inadequateRecords for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current]. Specifically, ***
1450821 CFR 812.140(a)(4)6Investigator record of protocol deviations inadequateRecords showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete] [current]. Specifically,***
263021 CFR 820.30(e)5Design review - documentationThe 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, ***
311121 CFR 820.70(f)5BuildingsBuildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations] [prevent mix-ups] [assure orderly handling of product]. Specifically, ***
311521 CFR 820.70(h)5Use and removal, Lack of or inadequate proceduresProcedures for the use and removal of manufacturing material have not been [adequately] established. Specifically, ***
313921 CFR 820.1405Lack of or inadequate procedures for handlingProcedures for product handling have not been [adequately] established. Specifically, ***
330921 CFR 820.120(b)5Examination 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, ***
331021 CFR 820.120(b)5DHR 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, ***
1472121 CFR 820.70(g)(2)5Periodic equipment inspectionsPeriodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance schedules [were not documented]. Specifically, ***
233921 CFR 820.224Quality Audit/Reaudit - documentationThe dates of quality [audits][reaudits] have not been documented. Specifically, ***
317521 CFR 820.1864QSRThe quality system record has not been [adequately] maintained Specifically ***
320021 CFR 820.40(a)4Document locations, Dissemination, etc.Documents were not available at all locations for which they are designated, used, or otherwise necessary. Specifically, ***
320421 CFR 820.40(b)4Change 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, ***
323021 CFR 820.70(i)4Validation 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, ***
343421 CFR 820.75(c)4Documentation - 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, ***
369921 CFR 820.160(b)4Distribution recordsDistribution records [were not maintained] [do not include or refer to the location of required information]. Specifically, ***
1471721 CFR 820.30(g)4Design validation - software validation documentationResults of the validation of the device software were not [adequately] documented. 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, ***
64221 CFR 803.18(b)(1)(i)3Adverse 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, ***
264821 CFR 820.30(f)3Design verification proceduresProcedures for verifying that design output meets design input were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
294921 CFR 812.46(a)3Sponsor securing investigator complianceAn investigator was not complying with the [signed agreement] [investigational plan] [requirements of the regulations] [conditions of approval imposed by the IRB or FDA] and [compliance of the investigator was not promptly secured] [shipments of the investigational device to the investigator were not discontinued] [the investigator's participation in the investigation was not terminated]. Specifically, ***
296921 CFR 812.1003No investigator protection - subject rights, safety, welfareThe rights, safety, and welfare of subjects in an investigational study were not [adequately] protected. Specifically, ***
300721 CFR 812.140(d)3Record 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, ***
302121 CFR 812.150(a)(1)3Investigator 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, ***
313821 CFR 820.1303PackagingDevice 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, ***
314721 CFR 820.170(a)3Lack of or inadequate instructions[Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established. Specifically,***
319821 CFR 820.40(b)3Document changes, review and approval, communicationChanges 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, ***
323621 CFR 820.72(b)3Calibration procedures - contentCalibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action]. Specifically, ***
323921 CFR 820.72(b)3Remedial action - documentationEvaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, ***
330821 CFR 820.120(a)3Remain legibleLabels were not [printed] [applied] [affixed] so as to remain [legible] [affixed] during processing, storage, handling, distribution, and/or use. 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, ***
418921 CFR 820.198(a)3GeneralComplaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented]. Specifically, ***
419321 CFR 806.10(b)3Time 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, ***
680221 CFR 807.21(a)3Annual registrationYour annual registration [is not current] [was not updated within 30 days of receipt of form FDA 2891a from FDA]. Specifically, ***
684721 CFR 807.30(b)3Listing not updated or update not timelyDevice listing information was not updated [in a timely manner]. Specifically, ***
1451621 CFR 812.25(e)3Sponsor's lack of written monitoring proceduresThere are no written procedures for monitoring an investigational device study. Specifically,***
1452321 CFR 812.43(c)3No investigator agreementA signed investigator agreement was not obtained from each participating investigator . Specifically,***
63621 CFR 803.17(b)(2)2Reports 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, ***
73321 CFR 803.50(b)(1)2Reporting Information Reasonably KnownAn MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer. Specifically, ***
233821 CFR 820.222Quality audit - audit report reviewReports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited. Specifically, ***
262821 CFR 820.30(e)2Design 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, ***
302821 CFR 812.150(a)(4)2No 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, ***
311321 CFR 820.70(g)2Equipment design and installationEquipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***
322421 CFR 820.70(g)(2)2Periodic equipment inspection lack of or inadequate proceduProcedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately] established. Specifically, ***
323721 CFR 820.72(b)2Remedial 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, ***
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, ***
331221 CFR 820.120(d)2MixupsLabeling and packaging operations were not controlled to prevent labeling mix-ups. Specifically, ***
332321 CFR 820.170(b)2Installer recordsThe person installing the device did not [adequately] document the inspection and test results to demonstrate proper installation.
332821 CFR 820.180(b)2Retention 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, ***
333221 CFR 820.184(e)2ID label, labelingThe device history record does not include the primary identification label and labeling for each device. Specifically, ***
334721 CFR 820.200(c)2Service reports/MDRs/complaintsService reports that represent MDR reportable events were not automatically considered complaints and processed in accordance with the requirements of 21 CFR 820.198. Specifically, ***
335521 CFR 820.198(f)2Records accessibilityInvestigated complaints and records of investigation were not accessible to the manufacturing establishment. Specifically, ***
367221 CFR 820.30(c)2Design input - review and approvalDesign input requirements were not [reviewed] [approved] by designated individual(s). Specifically, ***
421021 CFR 806.20(b)(2)2Device model identificationThe records of devices subject to correction and removal actions did not contain the [model] [catalog] [code number] of the device and the manufacturing [lot] [serial number] [identifying number] of the device. Specifically,***
421121 CFR 806.20(b)(3)2EventsA description of the events that led to the correction or removal actions was not contained in the record. 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,***
680421 CFR 807.21(b)2Listing not updatedExisting device information changed, but the listing was not updated during [June] [December] (or earlier) as required. Specifically, ***
700621 CFR 812.43(c)(5)2No 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, ***
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, ***
1452121 CFR 812.36(e)2No IRB approval for treatment useA treatment use study of an investigational device did not [comply with the regulations governing informed consent] [have IRB approval]. Specifically, ***
63821 CFR 803.17(b)(4)1Info which facilitates timely FDA follow-upThe written MDR procedure does not include documentation and recordkeeping requirements for systems that ensure access to information that facilitates timely follow-up and inspection by FDA. Specifically, ***
64421 CFR 803.18(b)(1)(ii)1Files do not contain copies of MDR formsMDR event files do not contain copies of all MDR forms and other information related to the event that was submitted to [FDA] [the manufacturer] [the importer] [the distributor] [other entities]. Specifically, ***
65021 CFR 803.18(e)1Results of evaluation not in mfr's MDR fileThe results of the evaluation of each event are not documented and maintained in the manufacturer's MDR event file. Specifically, ***
65821 CFR 803.30(a)(2)1Report of Serious Injury Within 10 DaysThe user facility did not submit FDA Form 3500A or electronic equivalent to the [known device manufacturer] [FDA, because the device manufacturer was unknown,] within 10 working days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility. Specifically, ***
73821 CFR 803.52(a)(1)1Patient Name or Other IdentifierAn individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient name or other identifier. Specifically, ***
73921 CFR 803.52(a)(2)1Patient Age or Date of BirthAn individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient's age or date of birth. Specifically, ***
74021 CFR 803.52(a)(3)1Patient GenderAn individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient's gender. Specifically, ***
75121 CFR 803.52(b)(5)1Description of the Event or ProblemAn individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B a description of the event or problem to include [a discussion of how the device was involved] [the nature of the problem] [the patient follow-up or required treatment] [any environmental conditions that may have influenced the event]. Specifically, ***
77821 CFR 803.52(f)(1)1Type of Reportable EventAn individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H the type of reportable event. 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, ***
79621 CFR 803.55(a)1Initial 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, ***
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, ***
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, ***
293321 CFR 812.43(a)1Investigator(s) not qualifiedOne or more investigators were selected who were not qualified by [training] [experience] to investigate a device. 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, ***
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, ***
294021 CFR 812.43(c)(4)(i)1No investigation agreement statement of commitmentA signed agreement that includes a statement of the investigator's commitment to conduct an investigation in accordance with the [agreement] [investigational plan] [applicable FDA regulations] [conditions of approval imposed by the reviewing IRB] [conditions of approval imposed by the FDA] was not obtained from each participating investigator. Specifically, ***
295621 CFR 812.46(c)1No approval to resume significant risk studyA terminated significant risk device study was resumed without [IRB] [FDA] approval. Specifically, ***
297321 CFR 812.110(a)1Subject participation prior to study approvalSubjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct the investigation. 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, ***
299221 CFR 812.140(b)(2)1Sponsor 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, ***
299321 CFR 812.140(b)(2)1Sponsor 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, ***
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, ***
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, ***
300321 CFR 812.140(b)(6)1Other 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, ***
300921 CFR 812.140(e)1Notice of transfer of responsibility for recordsA notice of transfer of responsibility for the maintenance of required records was not submitted [within 10 working days after the transfer occurred]. Specifically, ***
302521 CFR 812.150(a)(3)1No investigator progress reportsProgress reports on the investigation were not submitted [at the required intervals] [at least yearly] to the [sponsor] [monitor] [reviewing IRB]. Specifically, ***
302921 CFR 812.150(a)(4)1Investigator report of emergency useThe [sponsor] [reviewing IRB] was not notified [within five working days] of a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency situation. Specifically, ***
304921 CFR 812.150(b)(5)1Sponsor 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, ***
306421 CFR 812.140(a)(4)1Investigator protocol records inadequateCopies maintained of the study protocol are not all [accurate] [complete] [current]. 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, ***
315521 CFR 820.181(a)1DMR device specificationsThe device master record does not include or refer to the location of device software specifications. Specifically, ***
328321 CFR 820.90(a)1Specific non-conforming product proceduresProcedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition] [investigation] of nonconforming product were not [defined] [documented] [complete]. Specifically, ***
333321 CFR 820.184(f)1Device identification, control numbersThe device history record does not include [certain] [any] device identifications and control numbers used. Specifically, ***
337121 CFR 820.198(a)(3)1Processing 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, ***
341121 CFR 820.200(d)(3)1Service dateService reports do not include the date of service. Specifically, ***
368221 CFR 820.70(d)1Implementing Personnel Procedures, Health, Cleanliness.Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented. Specifically, ***
369021 CFR 820.100(a)(3)1Identification 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, ***
369321 CFR 820.100(a)(5)1Implementing 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, ***
383821 CFR 820.40(a)1Document review procedures, designated individualThe document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance. Specifically, ***
419721 CFR 806.10(c)(4)1Device marketing statusThe report to FDA of the correction or removal of a device did not identify the device's [510(k)] [PMA] [preamendment] [premarket exempt] [device listing number] status. 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,***
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,***
421621 CFR 806.301Access not permittedFDA personnel were not permitted access to required records and reports for devices subject to correction and removal actions. Specifically,***
422821 CFR 821.25(a)1Written tracking programAn adequate written device tracking program was not [adopted] [established] [complete] [implemented] for each device subject to a tracking order. Specifically, ***
425321 CFR 821.25(d)1Notification of FDA re: non-compliant distributorFDA was not notified, nor were reasonable steps taken concerning a distributor who has not collected, maintained, or furnished any record or information required by the device tracking regulations. Specifically,***
443021 CFR 803.18(d)(1)1Distributor responsibilities for recordsDevice complaint records are not [established] [maintained] by the device distributor, including any relevant [incident information] [information regarding the evaluation of the allegations]. Specifically, ***
443721 CFR 803.40(b)1Report of malfunction likely to cause death or injuryThe importer failed to submit a report to the manufacturer on FDA Form 3500A within 30 days concerning information that one of the devices marketed by the importer has malfunctioned and that such device or a similar device marketed by the importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Specifically, ***
680121 CFR 807.21(a)1Initial registrationAn initial establishment registration was not submitted within 30 days after starting an operation requiring registration. Specifically,
701221 CFR 812.1001Investigator lack of control of investigational devicesDevices under investigation were not properly controlled. Specifically, ***
701821 CFR 812.150(b)(5)1Sponsor progress reports for treatment IDE studySemi-annual progress reports for a treatment IDE study were not submitted to [FDA] [all reviewing IRBs]. Specifically, ***
911121 CFR 809.10(a)(4)1Hazard warnings/limiting statementsAn in vitro diagnostic [product label] [outside container] [wrapper] does not bear [warnings appropriate to the hazard presented by the product] [appropriate limiting statements to the intended use of the product] as required. Specifically, ***
912921 CFR 809.10(b)(5)(iv)1Storage-instructions (no manipulation of reagent)Labeling accompanying a reagent [does not include appropriate storage instructions adequate to protect product stability] [does not have storage instructions which are based on reliable, meaningful, and specific test methods]. 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, ***
1473021 CFR 860.7(g)(2)1Rpts of safety & effectiveness, adulteration or misbrandingThe [manufacturer][importer][distributer] failed to [make required reports][provide other information] bearing on the classification of a device and indicating whether [there is a reasonable assurance of the safety and effectiveness of the device][it is adulterated or misbranded under the act]. Specifically***
17003FDCA 501(a)1Medical Device Field ExamDuring a field examination of medical device products at your facility the following [was] [were] observed:

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Drugs

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Drugs110521 CFR 211.22(d)169Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***
202721 CFR 211.192119Investigations 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, ***
136121 CFR 211.100(a)116Absence 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, ***
360321 CFR 211.160(b)115Scientifically 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, ***
358521 CFR 211.110(a)89Control 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, ***
121521 CFR 211.67(b)73Written 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, ***
127421 CFR 211.68(a)69Calibration/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, ***
111221 CFR 211.25(a)65Training--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, ***
121321 CFR 211.67(a)65Cleaning / 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, ***
135821 CFR 211.100(b)64SOPs 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)62Testing 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 211.18856Prepared 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, ***
113321 CFR 211.25(a)54GMP 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, ***
117721 CFR 211.6354Equipment 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, ***
145121 CFR 211.113(b)47Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***
189021 CFR 211.165(e)46Test methodsThe [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, ***
191421 CFR 211.166(a)46Lack of written stability programThere is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***
438921 CFR 211.198(a)45Procedures to be written and followedProcedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, ***
111121 CFR 211.25(a)44Training , 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, ***
241921 CFR 211.198(a)43Complaint Handling ProcedureProcedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed]. Specifically, ***
435221 CFR 211.160(b)(4)42Calibration - 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, ***
431421 CFR 211.84(d)(2)41Reports 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, ***
900121 CFR 211.22(a)41Lack of quality control unitThere is no quality control unit. Specifically, ***
202621 CFR 211.19240Quality 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, ***
439121 CFR 211.180(e)(2)40Items 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, ***
203121 CFR 211.194(a)38Complete 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, , ***
434021 CFR 211.14238Written warehousing procedures established/followedProcedures describing the warehousing of drug products are not [established] [followed]. Specifically, ***
180921 CFR 211.160(a)37Following/documenting laboratory controlsEstablished [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***
191221 CFR 211.166(a)37Written program not followedThe written stability testing program is not followed. Specifically, ***
430321 CFR 211.67 b)36Written 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, ***
356521 CFR 211.5835Buildings 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, ***
357221 CFR 211.100(b)33Procedure Deviations Recorded and JustifiedDeviations from written production and process control procedures are not [recorded] [justified]. Specifically, ***
194321 CFR 211.180(e)(1)31Review 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, ***
178721 CFR 211.80(a)30Procedures 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, ***
440221 CFR 211.19229Written 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, ***
181021 CFR 211.160(a)28Lab 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, ***
197521 CFR 211.18228Written records kept in individual logsWritten records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, ***
434221 CFR 211.142(b)27Storage 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, ***
145021 CFR 211.113(a)26Procedures for non-sterile drug productsProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed]. Specifically, ***
183321 CFR 211.84(d)(1)26Identity 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, ***
457621 CFR 211.19226No 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, ***
176721 CFR 211.137(a)25Expiration 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, ***
357121 CFR 211.100(a)25Changes 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, ***
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, ***
188521 CFR 211.165(b)23Microbiological testingEach batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, ***
180121 CFR 211.84(a)22Components 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, ***
192021 CFR 211.166a)(3)22Valid stability test methodsThe written stability program for drug products does not include [reliable] [meaningful] [specific] test methods. Specifically, ***
358321 CFR 211.110(a)21Written 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, ***
194221 CFR 211.180(e)20Records 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, ***
109821 CFR 211.22(c)19Approve 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, ***
122721 CFR 211.67(c)19Cleaning/maintenance records not keptRecords are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, ***
126321 CFR 211.68(b)19Computer 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, ***
202821 CFR 211.19219Extent 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, ***
357021 CFR 211.100(a)19Approval 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, ***
441321 CFR 211.194(a)(8)19Second 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, ***
360221 CFR 211.160(a)18Deviations from laboratory control requirementsDeviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified]. Specifically, ***
139521 CFR 211.10317Actual 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, ***
355921 CFR 211.56(a)17Sanitation--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, ***
363221 CFR 211.170(b)17Annual 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, ***
430621 CFR 211.80(a)17Written Procedures Not FollowedWritten procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***
440121 CFR 211.186(b)(9)17Complete 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, ***
119421 CFR 211.42(c)16Defined areas of adequate size for operationsThe [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***
144821 CFR 211.11116Establishment 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, ***
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, ***
192621 CFR 211.166(b)16Adequate 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, ***
356121 CFR 211.56(b)16Written 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, ***
363921 CFR 211.20416Returned drug procedures in writing and followedProcedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed]. 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, ***
145221 CFR 211.113(b)15Validation 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, ***
155021 CFR 211.125(f)15Procedures Written and FollowedProcedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***
184421 CFR 211.84(d)(2)15Establish 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, ***
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, ***
431521 CFR 211.84(d)(2)15Testing Each Component for Conformity with SpecsEach component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, ***
433621 CFR 211.15015Written distribution procedureWritten distribution procedures are not [established] [followed]. Specifically, ***
437221 CFR 211.188(b)(8)15Labeling 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, ***
116921 CFR 211.42(a)14Buildings 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, ***
179021 CFR 211.80(b)14Handling 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, ***
200821 CFR 211.186(a)14Written procedures followedProcedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, ***
220521 CFR 211.186(b)(9)14Manufacturing 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, ***
261921 CFR 211.198(b)(2)14Complaint Investigation/Follow-Up FindingsComplaint records are deficient in that they do not include the findings of the [investigation] [follow-up]. Specifically, ***
361321 CFR 211.160(b)(4)14Establishment of calibration proceduresProcedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed]. Specifically, ***
189121 CFR 211.165(f)13Failing drug products not rejectedDrug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, ***
204421 CFR 211.19613Distribution 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, ***
433821 CFR 211.150(b)13Recall 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, ***
435721 CFR 211.166(a)13Results not used for expiration dates, storage cond.Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, ***
673221 CFR 314.80(c)(1)(i)13Late 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, ***
890721 CFR 314.81(b)(1)(ii)13Contamination, 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, ***
104921 CFR 211.22(a)12Approve 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, ***
437821 CFR 211.188(b)(2)12Identity 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, ***
673021 CFR 314.80(b)12Failure to develop written proceduresWritten procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences. Specifically, ***
141121 CFR 211.105(b)11Distinctive 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, ***
103321 CFR 211.22(a)10Authority 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, ***
116221 CFR 211.28(a)10Protective Apparel Not WornProtective apparel is not worn as necessary to protect drug products from contamination. Specifically, ***
177721 CFR 211.150(b)10Distribution Recall SystemThe distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary. Specifically, ***
361621 CFR 211.165(d)10Acceptance 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, ***
432821 CFR 211.122(a)10Written procedures not followedWritten procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed. Specifically, ***
113421 CFR 211.25(b)9Supervisor 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, ***
126121 CFR 211.68(a)9Written 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, ***
149521 CFR 211.122(a)9Written 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, ***
177421 CFR 211.142(a)9Quarantine - actual practiceDrug products are not quarantined before being released by the quality control unit. Specifically, ***
435321 CFR 211.160(b)(4)9Instruments, apparatus, et. al. not meeting specsThe use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed. Specifically, ***
115921 CFR 211.28(a)8Clothing 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, ***
180221 CFR 211.84(b)8Representative SamplesRepresentative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination. Specifically, ***
188621 CFR 211.165(c)8Sampling 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, ***
200721 CFR 211.186(a)8Signature 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, ***
354521 CFR 211.448Adequate lighting not providedAdequate lighting is not provided in all areas. Specifically, ***
355721 CFR 211.528Washing and toilet facilities are deficientWashing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness]. Specifically, ***
359121 CFR 211.110(b)8In-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, ***
362921 CFR 211.170(b)8Reserve 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, ***
430721 CFR 211.80(d)8Status 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, ***
435121 CFR 211.160(b)(3)8Drug products - samples representative, identified properlySamples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified]. Specifically, ***
436921 CFR 211.188(b)(11)8Identification 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, ***
438821 CFR 211.198(a)8Complaints 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, ***
440021 CFR 211.186(b)(8)8Description 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, ***
1776421 CFR 212.20(e)8Written QA procedures established, followedYou did not [establish] [follow] written quality assurance procedures. Specifically,***
203421 CFR 211.194(d)7Laboratory equipment calibration recordsLaboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices]. Specifically, ***
430221 CFR 211.56(b)7Written sanitation procedures not followedWritten procedures for sanitation are not followed. Specifically, ***
432521 CFR 211.110(a)7Control 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,***
435521 CFR 211.165(c)7Sampling and testing plans not followedWritten procedures for sampling and testing plans are not followed for each drug product. Specifically, ***
439921 CFR 211.186(b)(7)7Theoretical 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, ***
127021 CFR 211.68(b)6input/output verificationInput to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, ***
143421 CFR 211.42(c)(10)(iv)6Environmental Monitoring SystemAseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***
192221 CFR 211.166(a)(4)6Testing 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, ***
203221 CFR 211.194(b)6Test method modification records not maintainedComplete records are not maintained of any modification of an established method employed in testing. Specifically, ***
358221 CFR 211.105(a)6Identification 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, ***
431721 CFR 211.84(d)(3)6Certificates 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, ***
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, ***
891221 CFR 314.81(b)(2)6Timely 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, ***
1774121 CFR 212.30(b)6Equipment not cleanYou did not implement procedures to ensure that all your equipment is clean. Specifically, ***
1776321 CFR 212.20(d)6Determination need for investigationWhen errors occurred or a production batch failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary. Specifically,***
1781221 CFR 212.506Adequate controls (general)Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity. Specifically,***
107921 CFR 211.22(a)5Contract 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, ***
108621 CFR 211.22(b)5Adequate 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, ***
113621 CFR 211.25(c)5Inadequate number of personnelThe number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***
145421 CFR 211.115(a)5Reprocessing 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, ***
150521 CFR 211.122(d)5Label storage access limited to authorized personnelAccess to the storage area for labels and labeling materials is not limited to authorized personnel. Specifically, ***
163221 CFR 211.130(c)5Lot 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, ***
179421 CFR 211.80(d)5Disposition 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, ***
179721 CFR 211.82(a)5Examination 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, ***
179821 CFR 211.82(b)5Quarantine 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, ***
180321 CFR 211.84(b)5Representative Samples CriteriaThe [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria. Specifically, ***
197621 CFR 211.1825Specific information required in individual logsIndividual equipment logs do not show [time] [date] [product] [lot number of each batch processed]. Specifically, ***
197821 CFR 211.1825Personnel 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, ***
203321 CFR 211.194(c)5Testing 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, ***
256921 CFR 211.198(b)5Maintenance of Complaint FileComplaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints. Specifically, ***
355821 CFR 211.525Washing and toilet facilities not provided and accessibleWashing and toilet facilities are not [provided] [easily accessible to working areas]. Specifically, ***
356221 CFR 211.56(c)5Written 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, ***
356921 CFR 211.895Quarantine 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, ***
359221 CFR 211.110(c)5In-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, ***
436821 CFR 211.188(b)(12)5Investigations 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, ***
437521 CFR 211.188(b)(5)5In-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, ***
438621 CFR 211.198(b)5Written 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, ***
683121 CFR 314.80(c)(2)5Late 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, ***
891121 CFR 314.81(b)(1)(ii)5Failure 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, ***
1777021 CFR 212.40(a)5Suitable for intended useYour written procedures are not adequate to ensure that the [components] [containers] [closures] are suitable for their intended use. Specifically,***
1785121 CFR 212.60(c)5Analytical methodsYour laboratory analytical methods [are not suitable for their intended use] [are not sufficiently sensitive] [are not sufficiently specific] [are not accurate] [are not reproducible]. Specifically,***
141321 CFR 211.42(c)(5)4Mfg / Processing Operations AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. Specifically, ***
154521 CFR 211.125(c)4Label reconciliation discrepancies evaluation/investigationDiscrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated] [investigated]. Specifically, ***
162921 CFR 211.130(a)4Prevention 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, ***
163021 CFR 211.130(b)4Unlabeled 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, ***
163321 CFR 211.130(d)4Examination 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, ***
172821 CFR 211.874Retest 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, ***
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, ***
187921 CFR 211.180(c)4Records 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, ***
191821 CFR 211.166(a)(2)4Stability sample storage conditions describedThe written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically, ***
192821 CFR 211.166(c)(1)4Homeopathic 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, ***
195821 CFR 211.180(f)4Responsible 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, ***
239921 CFR 211.194(a)(2)4Laboratory Test Method VerificationVerification of the suitability of the testing methods is deficient in that they are not [performed under actual conditions of use] [documented on the laboratory records]. Specifically, ***
240121 CFR 211.194(a)(4)4Complete Test DataLaboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***
261821 CFR 211.198(b)(1)4Complaint 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, ***
344521 CFR 211.65(a)4Equipment 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, ***
355321 CFR 211.48(a)4Plumbing System DefectsThe plumbing system contains defects that could contribute to the contamination of drug products. Specifically, ***
362321 CFR 211.170(a)4Active ingredient retained sample keptA sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained]. Specifically, ***
430521 CFR 211.68(b)4Backup data not assured as exact and completeBackup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems. Specifically, ***
430921 CFR 211.84(c)(2)4Containers sampled so as to prevent contaminationContainers are not [opened] [sampled] [resealed] in a manner designed to prevent contamination of [their contents] [other components] [other drug product containers or closures]. Specifically, ***
432021 CFR 211.84(d)(6)4Microbiological 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, ***
432321 CFR 211.115(a)4Reprocessing 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, ***
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, ***
435021 CFR 211.160(b)(3)4Drug products-sampling procedures/specificationsLaboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products. Specifically, ***
437621 CFR 211.188(b)(4)4Weights 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, ***
437721 CFR 211.188(b(3)4Identification 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, ***
682921 CFR 314.80(c)(2)4Failure 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, ***
1785321 CFR 212.60(d)4Supplies adequately controlledYour [reagents] [solutions] [supplies] used in your testing procedures are not adequately controlled. Specifically,***
116421 CFR 211.28(c)3Unauthorized Personnel in Limited Access AreasUnauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas. Specifically, ***
116821 CFR 211.343Consultant RecordsRecords are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided]. Specifically, ***
122421 CFR 211.67(b)(6)3Cleaning SOP/inspectionProcedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. Specifically, ***
142121 CFR 211.42(c)(10)3Aseptic Processing AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. Specifically,***
143321 CFR 211.42(c)(10)(iii)3Air SupplyAseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. 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, ***
154121 CFR 211.125(b)3Examination of issued labelsLabeling materials issued for a batch were not carefully examined for identity and conformity to the labeling specified in the master or batch production records. Specifically, ***
163621 CFR 211.130(e)3Packaging 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, ***
172521 CFR 211.134(c)3Examinations documentedThe results of the examination of the packaged and labeled products were not documented in the batch production or control records. Specifically, ***
176821 CFR 211.137(b)3Storage conditionsDrug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies. Specifically, ***
179621 CFR 211.80(d)3Identification 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, ***
182321 CFR 211.84(c)(4)3Top/Middle/Bottom container samplingSampling procedures are deficient regarding sampling components from the top, middle, and bottom of container. Specifically, ***
185221 CFR 211.94(a)3Reactive/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, ***
191721 CFR 211.166(a)(1)3Sample 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, ***
193221 CFR 211.167(a)3Sterility/pyrogen-free testingEach batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements. 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, ******
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, ***
200321 CFR 211.184(c)3Individual 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, ***
203521 CFR 211.194(e)3Stability testing records not includedLaboratory records do not include complete records of all stability testing performed. Specifically, ***
242021 CFR 211.198(a)3Quality 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, ***
256721 CFR 211.198(a)3Adverse 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, ***
358821 CFR 211.110(a)(3)3Mixing 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, ***
364021 CFR 211.2043Returned drug products identified and heldReturned drug products are not [identified as such] [held]. 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, ***
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.
437321 CFR 211.188(b)(7)3Actual 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, ***
440321 CFR 211.194(b)3Test 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, ***
440521 CFR 211.194(a)(2)3Statement 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, ***
440921 CFR 211.194(a)(4)3Data 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, ***
441221 CFR 211.194(a)(7)3Signatures 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, ***
441821 CFR 211.42(b)3Adequate 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, ***
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, ***
682321 CFR 314.80(c)3Failure by applicant to report ADEAdverse drug experience information has not been reported to FDA. Specifically, ***
890621 CFR 314.81(b)(1)(i)3Mix-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, ***
1774621 CFR 212.30(b)3Not capable of repeatable valid resultsYou did not document your activities in accordance with your procedures for ensuring the equipment is [properly installed] [maintained] [capable of repeatedly producing valid results]. Specifically,***
1776521 CFR 212.20(d)3Review of records for errorsYou did not review production records to determine whether errors had occurred. Specifically,***
1781321 CFR 212.50(a)3Written control proceduresYou did not have written production and process control procedures to [ensure] [document] that [all key process parameters are controlled] [any deviations from the procedures are justified]. Specifically,***
1785021 CFR 212.60(b)3Lab sampling and test proceduresEach laboratory did not have sampling procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,***
1785521 CFR 212.60(e)3EquipmentAll equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing valid results]. Specifically,***
1786321 CFR 212.60(g)(3)3Record of all test dataLaboratory records did not contain a complete record of all data obtained in the course of each test. Specifically,***
1793221 CFR 212.60(b)3Testing Procedures- Conformance to StandardsEach laboratory did not have testing procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,***
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, ***
138821 CFR 211.101(d)2Component addition checked by 2nd personEach component is not added to a batch by one person and verified by a second person. Specifically, ***
139321 CFR 211.1032Yield calculations not verified by 2nd personYield calculations are not performed by one person and independently verified by a second person. Specifically, ***
143021 CFR 211.42(c)(10)(i)2Floors, walls, ceiling surfacesAseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,***
144921 CFR 211.1112Deviations of production time limitsDeviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product]. Specifically, ***
150421 CFR 211.122(d)2Labels and labeling stored separatelyLabels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents. 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,***
184321 CFR 211.84(d)(2)2Component 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, ***
199921 CFR 211.184(a)2Record information requiredThe records for [components] [drug product containers or closures] [labeling] do not include the [identity and quantity of each shipment of each lot] [name of the supplier] [supplier's lot number] [receiving code] [date of receipt] [name of the prime manufacturer if different from the supplier] [location of the prime manufacturer]. Specifically, ***
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, ***
201121 CFR 211.188(a)2Accurate 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, ***
201221 CFR 211.188(b)2Batch production and Batch Control Record RequirementsThe batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in [manufacturing] [processing] [packing] [holding]. Specifically, ***
201521 CFR 211.188(b)(3)2Identification of Components and In-Process MaterialsThe batch production and control records are deficient in that they do not include specific identification of each [batch of component] [in-process material] used. Specifically, ***
201721 CFR 211.188(b)(5)2In-Process and Laboratory Control ResultsThe batch production and control records are deficient in that they do not include [in-process] [laboratory] control results. 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, ***
202221 CFR 211.188(b)(10)2Documentation of Sampling PerformedThe batch production and control records are deficient in that they do not include documentation of sampling performed. 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, ***
220021 CFR 211.186(b)(4)2Variation 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, ***
240621 CFR 211.194(a)(8)2Identification 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, ***
257221 CFR 211.198(b)2Complaint File LocationComplaint procedures are deficient in that written complaint files are not maintained at the manufacturing site nor were they readily available from their off-site location. Specifically, ***
262121 CFR 211.198(b)(3)2Reason 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, ***
355621 CFR 211.502Sewage and refuse disposal in safe mannerDisposal of [sewage] [trash] [refuse] from the [building] [immediate premises] is not done in a safe and sanitary manner. Specifically, ***
360921 CFR 211.160(b)(2)2In-process sample representation/identificationIn-process samples are not [representative] [properly identified]. 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, ***
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, ***
363021 CFR 211.170(b)2Drug 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, ***
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, ***
430421 CFR 211.68(b)2Written 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, ***
431621 CFR 211.84(d)(3)2Testing Containers & Closures Conformity with SpecsContainers and closures are not tested for conformance with all appropriate written procedures. Specifically, ***
432721 CFR 211.122(c)2Records 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, ***
434421 CFR 211.160(b)(1)2Sampling and testing procedures describedWritten specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used. 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, ***
434721 CFR 211.160(b)(2)2In process materials - conformance to written specsLaboratory controls do not include a determination of conformance to written specifications for in-process materials. Specifically, ***
435421 CFR 211.165(d)2Acceptance/Rejection LevelsThe statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels]. Specifically, ***
435621 CFR 211.166(b)2Tentative 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, ***
436621 CFR 211.188(a)2Accurate 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, ***
437021 CFR 211.188(b)(10)2Records 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, ***
437421 CFR 211.188(b)(6)2Inspection 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, ***
437921 CFR 211.188(b)(1)2Dates 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, ***
438021 CFR 211.198(b)(3)2Determination 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, ***
438221 CFR 211.198(b)(2)2Written 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, ***
438321 CFR 211.198(b)(1)2Written 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, ***
438721 CFR 211.198(a)2Reporting 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, ***
440421 CFR 211.194(a)(1)2Sample 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, ***
441021 CFR 211.194(a)(5)2Calculations performed are in the recordsLaboratory records do not include a record of all calculations performed in connection with the test. Specifically, ***
441421 CFR 211.2042Record information maintainedRecords of returned drug products are not maintained. Specifically, ***
670521 CFR 310.305(c)2Failure to reportAdverse drug experience information has not been reported to FDA. 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, ***
891421 CFR 314.81(b)(2)(iv)(b)2Mfg 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, ***
1002121 CFR 314.98(a)2(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.)
1772221 CFR 212.102Lack Adequate Resources, Facilities, Equipment.You lack adequate [resources] [facilities] [equipment] to enable your personnel to perform their functions. Specifically, ***
1774921 CFR 212.30(a)2Prevention of contaminationYour facilities are not adequate to ensure the prevention of contamination of [equipment] [product] by [substances] [personnel] [environmental conditions] that could reasonably be expected to have an adverse effect on product quality. Specifically,***
1781421 CFR 212.50(b)2Records to document all stepsYou did not have master production and control records that document all steps in the PET drug production process. Specifically,***
1782221 CFR 212.50(b)(7)2Complete instructions, procedures, specsYour master production and control records did not contain [complete production and control instructions] [complete sampling and testing procedures] [complete specifications] [special notations] [precautions to be followed]. Specifically,***
1789721 CFR 212.71(b)2Investigation of nonconforming productYou did not [completely] document the investigation of a PET drug product that did not meet specifications. Specifically,***
1791321 CFR 212.100(a)2Written complaint proceduresYou have not [developed] [followed] written procedures for the receipt and handling of all complaints concerning the quality or purity of, or possible adverse reactions to, a PET drug product. Specifically,***
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, ***
122321 CFR 211.67(b)(5)1Cleaning SOPs/equipment protectionProcedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use. Specifically, ***
126621 CFR 211.42(d)1Penicillin 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, ***
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, ***
138421 CFR 211.101(c)1Weighing/measuring/subdividing operationsComponent [weighing] [measuring] [subdividing] operations are not adequately supervised. 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, ***
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, ***
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, ***
149821 CFR 211.122(b)1Labeling and packaging improperly approved/releasedLabeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use]. Specifically, ***
150621 CFR 211.122(e)1Destruction of obsolete labelingObsolete or outdated labels, labeling and packaging materials are not destroyed. Specifically, ***
150921 CFR 211.122(h)1Printing 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, ***
154621 CFR 211.125(d)1Destruction of excess labels with lot numbersExcess labeling bearing lot or control numbers is not destroyed. Specifically, ***
163721 CFR 211.130(e)1Packaging 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, ***
172221 CFR 211.134(a)1Correct 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, ***
172421 CFR 211.134(b)1Representative samples after completionSamples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations. Specifically, ***
177621 CFR 211.150(a)1Distribution of oldest approved drugsThe oldest approved stock of drug products are not distributed first and there is no justification for this practice. Specifically, ***
179121 CFR 211.80(c)1Storage 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, ***
184521 CFR 211.84(d)(3)1Container/Closure Written Test ProcedureDrug product container and closure test procedures are deficient in that [containers] [closures] are not tested for conformance in accordance with appropriate written procedures. Specifically, ***
184621 CFR 211.84(d)(3)1Establish reliability of supplier's C of AEstablishment of the reliability of the [container] [closure] supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals. Specifically, ***
186821 CFR 211.94(b)1Protection 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, ***
187621 CFR 211.180(a), (b)1Record 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, ***
192421 CFR 211.166(a)(5)1Testing of reconstituted drugsThe written stability program does not include testing of drug products for reconstitution [at time of dispensing - as directed in the labeling] [after they are reconstituted]. Specifically, ***
192721 CFR 211.166(b)1Accelerated 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, ***
195721 CFR 211.180(e)(2)1Review 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, ***
201421 CFR 211.188(b)(2)1Identification of Equipment and LinesThe batch production and control records are deficient in that they do not include the identity of major [equipment] [lines] used. Specifically, ***
202021 CFR 211.188(b)(8)1Labeling 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, ***
207121 CFR 211.1731Animal housingAnimals used in the testing of [component] [in-process materials] [drug products] are not maintained and controlled in a manner that assures their suitability for their intended use. Specifically, ***
220221 CFR 211.186(b)(6)1Theoretical Weight and MeasureThe master production and control records are deficient in that they do not include a statement of theoretical [weight] [measure] at different phases of the processing. Specifically, ***
220321 CFR 211.186(b)(7)1Theoretical 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, ***
240421 CFR 211.194(a)(6)1Comparison of Test Results to SpecificationsLaboratory records are deficient in that they do not include a statement of the results of tests and how they compare to the established [specifications] [standards]. Specifically, ***
354621 CFR 211.46(a)1Adequate ventilation not providedAdequate ventilation is not provided. 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, ***
356321 CFR 211.56(c)1Rodenticides et. al. registration and usageRodenticides, insecticides and fungicides are not [registered] [used] in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135). Specifically, ***
357321 CFR 211.101(b)1Measured components for manufacturingComponents for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate]. Specifically, ***
358121 CFR 211.101(d)1Verification of component additionEach component is not added to the batch by one person and verified by a second person.. Specifically, ***
360521 CFR 211.160(b)(1)1Specification description of sample/testingThe specifications for components, drug product containers or closures and labeling are deficient in that they do not include a description of the [sampling plan] [testing procedures]. Specifically, ***
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, ***
361021 CFR 211.160(b)(3)1Drug product sampleDrug product samples are not [representative of the entire batch] [properly identified]. 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, ***
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, ***
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, ***
433021 CFR 211.130(e)1Packaging line inspection documentationResults of inspection of packaging and labeling facilities are not documented in the batch production records. Specifically, ***
433721 CFR 211.150(a)1Distribution of oldest stock firstDistribution procedures do not include a procedure whereby the oldest approved stock of a drug product is distributed first. Specifically, ***
434321 CFR 211.160(b)(1)1Incoming 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, ***
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, ***
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, ***
436421 CFR 211.1761Failing 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, ***
437121 CFR 211.188(b)(9)1Description 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, ***
439021 CFR 211.180c)1Photocopying of records not allowedRecords or copies of records were not made available for photocopying or other means of reproduction. Specifically, ***
439421 CFR 211.186(b)(3)1Components complete listingThe master production and control records do not include a complete list of components [designated by names or codes sufficiently specific to indicate any special quality characteristics]. Specifically, ***
439521 CFR 211.186(b)(4)1Weight or measure of each componentThe master production and control records lack an accurate statement of the [weight] [measure] of each component [using the same weight system for each component]. Specifically, ***
441121 CFR 211.194(a)(6)1Test 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, ***
441521 CFR 211.2041Returned 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, ***
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, ***
672021 CFR 310.305(d)(1)1Domestic adverse drug experience reporting formA FDA Form 3500A has not been completed for each report of a domestic adverse drug experience. Specifically, ***
673621 CFR 314.80(c)(1)(ii)1Submission 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, ***
683021 CFR 314.80(c)(2)1IntervalPeriodic 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, ***
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, ***
684021 CFR 314.80(f)(1)1Wrong form - domestic ADEAn FDA Form 3500A has not been completed for each report of a domestic adverse drug experience. Specifically, ***
684221 CFR 314.80(i)1Failure to maintain recordsRecords relating to all adverse drug experiences known to you, including raw data and any correspondence, have not been maintained for the required ten year period. Specifically, ***
890921 CFR 314.81(b)(2)(ii)1Distribution dataAn annual report did not include [information about the quantity of the drug product distributed under the approved application, including that distributed to distributors] [the National Drug Code (NDC) number] [the total number of dosage units of each strength or potency distributed] [the quantities distributed for domestic use] [the quantities distributed for foreign use]. Specifically, ***
8935FDCA 760(b)(1)1Failure of responsible person to report AE (non-RX Drug)Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to the Secretary. Specifically, ***
8944FDCA 760(e)(2)(A)1Records inspection denied (non-Rx drugs)Access to records related to serious adverse event(s) involving a nonprescription drug was not permitted. Specifically, ***
1001921 CFR 314.80(c)(1)(iii)1Non-applicant reports directly to FDAYou, as a non-applicant, did not elect to submit to the applicant all reports of adverse drug experiences that were both serious and unexpected. You were therefore obligated to submit those reports directly to FDA, but you did not submit each report [within five calendar days of your receipt of the information]. Specifically, ***
1002221 CFR 310.305(a)1Failure to develop written proceduresWritten procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of postmarketing adverse drug experiences. Specifically, ***
1774221 CFR 212.30(b)1Equipment not suitableYou did not implement procedures to ensure that all your equipment is suitable for its intended purposes. Specifically,***
1774521 CFR 212.30(b)1Equipment not properly maintainedYou did not document your activities in accordance with your procedures for ensuring the equipment suitability for its intended purposes. Specifically,***
1775521 CFR 212.20(a)1Oversight of production operationsYou did not oversee production operations in a manner to ensure that each PET drug [meets the requirements of the FD&C Act as to safety] [has the identity and strength that it is supposed to have] [meets the quality and purity characteristics that it is supposed to have]. Specifically, ***
1775721 CFR 212.20(b)1Examine, approve or rejectYou did not approve or reject [components] [containers] [closures] [in-process materials] [packaging materials] [labeling] [finished dosage forms] in a manner that ensures compliance with procedures and specifications affecting the identity, strength, quality or purity of a PET drug. Specifically,***
1776121 CFR 212.20(c)1Proposed changes to existing specs/methodsYou did not approve or reject, before implementation, proposed changes to existing [specifications] [methods] [processes] [procedures] to ensure that they would maintain the identity, strength, quality and purity of a PET drug. Specifically,***
1776921 CFR 212.40(a)1Content of written proceduresYou did not [establish] [maintain] [follow] appropriate written procedures that describe the [receipt] [login] [identification] [storage] [handling] [testing] [acceptance and/or rejection] of [components] [drug product containers] [closures]. Specifically,***
1777221 CFR 212.40(b)1Written specs - componentsYou did not establish appropriate written specifications for the [identity] [quality] [purity] of components. Specifically,***
1783321 CFR 212.50(c)(5)1Weights and ID codesYour batch production and control records did not include the [weights or other measure of quantity of components] [identification codes of components]. Specifically,***
1784121 CFR 212.50(d)1Production area & equipment checksYour [production area] [equipment in the production area] was not checked to ensure [cleanliness] [suitability] immediately before use. Specifically,***
1785721 CFR 212.60(f)1Lab written proceduresLaboratory written procedures are not [established] [followed] to ensure that the lab equipment is routinely [calibrated] [inspected] [checked] [maintained]. Specifically,***
1788521 CFR 212.70(e)130 hours after completionSterility testing on a final release PET drug was not started within 30 hours after completion of production. Specifically,***
1793621 CFR 212.70(e)1Appropriate Recommendations to Facilities Re: Sterility FailYou did not provide appropriate recommendations to all facilities that received a PET drug product that failed to meet a criterion for sterility. Specifically***

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Bioresearch monitoring

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Bioresearch monitoring756021 CFR 312.60132FD-1572, protocol complianceAn investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically***
753021 CFR 312.62(b)83Case 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, ***
731821 CFR 56.115(a)(2)34Minutes 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, ***
752621 CFR 312.62(a)30Accountability recordsInvestigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***
728121 CFR 56.108(a)(1)27Initial and continuing reviewsThe IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***
722721 CFR 50.27(a)20Consent 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, ***
733421 CFR 56.115(a)(5)19List 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, ***
748221 CFR 312.5017General 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, ***
749821 CFR 312.6615Unanticipated problemsFailure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. 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***
732121 CFR 56.110(c)12Method 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, ***
731621 CFR 56.115(a)(4)11Copies of IRB/CI correspondenceCopies have not been maintained of all correspondence between the IRB and the investigators. Specifically, ***
729021 CFR 56.108(c)9Members 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, ***
729321 CFR 56.109(f)9Continuing 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, ***
731721 CFR 56.115(a)(1)9Copies 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, ***
765621 CFR 56.108(c)9Approval 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, ***
733521 CFR 56.115(a)(6)8Written 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, ***
753121 CFR 312.62(c)8Record 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, ***
728621 CFR 56.108(b)(1)7Prompt 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, ***
734221 CFR 56.108(b)(2)7Prompt 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, ***
737121 CFR 56.108(a)(1)7Reporting 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, ***
738821 CFR 50.25(a)(2)7Reasonably foreseeable risks or discomfortsThe informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, ***
752021 CFR 312.64(b)7Safety 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, ***
720921 CFR 50.25(a)(1)6Procedures, 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, ***
723121 CFR 50.206Consent 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, ***
727821 CFR 56.107(e)6Conflict 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, ***
739121 CFR 50.25(a)(5)6Confidentiality, 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, ***
393121 CFR 58.35(b)(5)5QAU: 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, ***
733921 CFR 56.108(a)(4)5Changes 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, ***
734321 CFR 56.108(b)(3)5Reporting 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, ***
736821 CFR 56.108(a)(2)5More 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, ***
745321 CFR 312.56(b)5Investigator 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, ***
748021 CFR 312.505Ensuring 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, ***
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, ***
393221 CFR 58.35(b)(6)4QAU: 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, ***
395721 CFR 58.81(a)4SOPs: 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, ***
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, ***
402521 CFR 58.185(a)(9)4Final 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)4Final 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, ***
732021 CFR 56.109(e)4IRB 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, ***
739021 CFR 50.25(a)(4)4Alternate 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, ***
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, ***
765421 CFR 56.110(b)4Research 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, ***
390021 CFR 58.103Notifying 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, ***
390921 CFR 58.31(a)3Management: designating the study directorTesting facility management failed to designate a study director before each study was initiated. Specifically, ***
391921 CFR 58.33(b)3Study 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)3Study director: follow GLP regulationsThe study director failed to assure that all applicable GLP regulations were followed. Specifically, ***
392321 CFR 58.33(f)3Study 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, ***
395321 CFR 58.63(a)3Equipment: inspection, cleaning and maintenanceNot all equipment is adequately inspected, cleaned, and maintained. Specifically, ***
400721 CFR 58.130(a)3Conduct: in accordance with protocolNot all nonclinical laboratory studies were conducted in accordance with the protocol. Specifically, ***
727621 CFR 56.107(c)3One scientific and one non-scientific memberThe IRB does not include [at least one member whose primary concerns are in the scientific area] [at least one member whose primary concerns are in nonscientific areas]. Specifically, ***
730521 CFR 56.110(b)(2)3Minor 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, ***
731921 CFR 56.115(a)(3)3Records of continuing reviewRecords have not been [prepared] [maintained] of all continuing review activities. Specifically, ***
733721 CFR 56.115(b)3Retention of recordsRecords required by 21 CFR 56 have not been maintained for three years following completion of the research. Specifically, ***
737021 CFR 56.111(c)3Children 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, ***
741121 CFR 312.53(c)(1)3Investigator statement (FDA 1572)Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation. Specifically, ***
747921 CFR 312.56(a)3Monitoring investigationsFailure to monitor the progress of an investigation conducted under your IND. Specifically, ***
751721 CFR 312.663Initial 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, ***
755221 CFR 312.663Changes in researchNot all changes in research activity were approved by an Institutional Review Board prior to implementation. 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, ***
390621 CFR 58.29(e)2Personnel: appropriate clothingNot all personnel engaged in a nonclinical laboratory studywear clothing appropriate for the duties they perform. 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, ***
391221 CFR 58.31(d)2Management: 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, ***
391321 CFR 58.31(e)2Management: availability of resourcesTesting facility management failed to assure that all personnel, resources, facilities, equipment, materials, and methodologies were available as scheduled. Specifically, ***
391821 CFR 58.33(a)2Study 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)2Study 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, ***
392421 CFR 58.35(a)2QAU: 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, ***
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, ***
392621 CFR 58.35(b)(1)2QAU: 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, ***
395421 CFR 58.63(a)2Equipment: calibrationNot all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized. Specifically, ***
395621 CFR 58.63(c)2Equipment: maintenance recordsAdequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations. Specifically, ***
395821 CFR 58.81(a)2SOPs: authorization and documentation of deviationsNot all deviations from standard operating procedures in a study were authorized by the study director anddocumented in the 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, ***
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, ***
402621 CFR 58.185(a)(10)2Final 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, ***
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, ***
727721 CFR 56.107(d)2One 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, ***
727921 CFR 56.107(f)2Invited 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, ***
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, ***:
734021 CFR 56.108(a)(3)2Prompt 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, ***
736921 CFR 56.109(h)2Children 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, ***
738921 CFR 50.25(a)(3)2Benefits 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)2Participation; 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, ***
745921 CFR 312.57(a)2Records of receipt, shipment, dispositionLack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug. Specifically, ***
750521 CFR 312.55(a)2Investigator brochureFailure to provide to an investigator, prior to the start of an investigation, a brochure containing all of the information required by 21 CFR 312.23(a)(5). Specifically, ***
752721 CFR 312.62(a)2Unused drug disposition (investigator)Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions]. Specifically, ***
753421 CFR 312.682FDA access to clinical investigator recordsFailure to permit an authorized officer or employee of FDA to [have access to] [copy] [verify] records or reports.Specifically, ***
754321 CFR 312.612Unauthorized 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, ***
768621 CFR 56.106(b)(3)2Number of active protocolsThe IRB registration does not state the approximate number of active protocols involving FDA-regulated products reviewed. 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, ***
390321 CFR 58.29(b)1Personnel: 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, ***
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, ***
392921 CFR 58.35(b)(3)1QAU: problems affecting study integrityThe quality assurance unit failed to immediately bring to the attention of the study director and management any problems found during the course of an inspection which are likely to affect study integrity. 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, ***
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, ***
394721 CFR 58.47(a)(2)1Facility: article mixing areasThe testing facility does not provide separate areas, as necessary, to prevent contamination or mix-ups in the mixing of the test and control articles with a carrier. Specifically, ***
395121 CFR 58.511Facility: 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, ***
396121 CFR 58.81(c)1SOPs: availabilityNot all laboratory areas have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. 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, ***
396521 CFR 58.90(a)1Animal care: SOPsStandard operating procedures for the housing, feeding, handling, and care of animals did not exist. Specifically, ***
400321 CFR 58.120(a)(10)1Protocol: records to be maintainedNot all protocols contained the records to be maintained. 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, ***
400621 CFR 58.120(b)1Protocol: 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, ***
401221 CFR 58.130(e)1Conduct: date and signNot all data entries were dated on the date of entry and signed or initialed by the person entering the data. Specifically, ***
401321 CFR 58.130(e)1Conduct: changes not obscuring original entriesNot all changes in entries were made so as not to obscure the original entry, indicated the reason for such change, and were dated and signed or identified at the time of the change. Specifically, ***
403221 CFR 58.185(c)1Final report: corrections or additionsNot all corrections or additions to a final report were in the form of an amendment by the study director. Specifically, ***
403521 CFR 58.190(a)1Archives: 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, ***
403621 CFR 58.190(b)1Archives: orderly storage, expedient retrievalArchives failed to provide for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Specifically, ***
404021 CFR 58.190(d)1Archives: unauthorized personnelUnauthorized personnel entered the archives.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, ***
722921 CFR 50.27(b)(1)1Adequate opportunity to read before signingThe investigator did not give [the subject] [the subject's legally authorized representative] adequate opportunity to read the informed consent document before it was signed. Specifically, ***
723021 CFR 50.27(b)(2)1Short form: Oral presentation/signingA short form informed consent document [did not state that the required elements of informed consent had been presented orally to the subject or the subject's legally authorized representative] [was not signed by the subject or the subject's legally authorized representative] [was not signed by the witness]. Specifically, ***
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, ***
729821 CFR 56.109(a)1Authority of the IRBThe IRB does not have the authority to [approve] [require modifications in] [disapprove] all research activities covered by the regulations. 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, ***
730921 CFR 56.111(a)(1)1Risks 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, ***
732421 CFR 56.111(a)(4)1Informed 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, ***
732521 CFR 56.111(a)(5)1Informed consent documentedThe IRB approved the conduct of research, but did not determine that informed consent would be appropriately documented. 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, ***
735321 CFR 50.521Factors 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, ***
735821 CFR 50.55(a)1Adequate provisions for assent of childrenFor a clinical investigation involving children, the IRB did not determine that adequate provisions had been made for soliciting the assent of the children when, in the judgment of the IRB, the children were capable of providing assent. 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, ***
745221 CFR 312.56(c)1IND safety reportFailure to provide [FDA] [all participating investigators] with [a] [an adequate] written IND safety report. Specifically, ***
748321 CFR 312.55(b)1New observations, adverse effects and risksNot all participating investigators were [promptly] informed of new observations discovered by or reported to the sponsor [with respect to adverse effects and safe use]. 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, ***
755521 CFR 312.53(d)1Selecting monitorsMonitors not qualified by experience and training were selected to monitor the progress of a clinical investigation. Specifically, ***
755721 CFR 312.56(b)1Notification of FDA of termination of investigatorFailure to notify FDA of the ending, for cause, of an investigator's participation in an investigation. Specifically, ***
755821 CFR 312.57(c)1Record retention requirementRecords and reports were not retained for two years after [marketing application approval] [discontinuance of the investigation and notification of FDA]. Specifically***
762921 CFR 312.56(c)1Annual reportFailure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation. 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
765021 CFR 56.1131Authority 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, ***
765221 CFR 56.1131ReportingThe IRB's [suspension] [termination of approval] for research was not reported [promptly] to [the investigator] [appropriate institutional officials] [the Food and Drug Administration]. Specifically, ***
765821 CFR 50.25(b)(2)1Termination by investigatorThe informed consent document did not include a statement of anticipated circumstances under which the subject's participation might be terminated by the investigator, without regard to the subject's consent. Specifically, ***
766021 CFR 50.24(a)(1)1IRB failed to find/document required conditionsIn approving an investigation without requiring informed consent, the IRB did not [find] [document] that [the human subjects were in a life-threatening situation] [available treatments were unproven or unsatisfactory] [the collection of valid scientific evidence was necessary to determine the safety and effectiveness of particular interventions]. Specifically, ***
766421 CFR 50.201Circumstances 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, ***
768421 CFR 56.106(b)(2)1IRB chairperson informationRegistration information does not include the [name] [phone number] [electronic mail address] of each IRB chairperson. Specifically, ***
768721 CFR 56.106(b)(4)1Description of types of productsThe IRB registration does not state the approximate number of active protocols involving FDA-regulated products reviewed. Specifically, ***
769221 CFR 56.106(e)1Changes in contact or chairperson informationThe IRB did not revise its registration information with respect to changes in [the contact person] [the chairperson] within 90 days of the change. Specifically, ***

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Veterinary medicine

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Veterinary medicine4185FDCA 402(a)(4)137Record keepingTreatment records were not [maintained] [complete]. Specifically,***
409321 CFR 530.11(d)89Tissue 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)51Drug inventoryYou lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock]. Specifically, ***
1360FDCA 501(a)(5)29Expired drugsExpired drug(s) were observed in the drug storage area. Specifically, ***
4182FDCA 501(a)(5)28Extra 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, ***
13509FDCA 402(a)(4)27Identity 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, ***
429821 CFR 530.11(a)21Rx 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, ***
136621 CFR 530.11(a)20Dosage levelAdministration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship. Specifically, ***
136221 CFR 530.11(a)15Species 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, ***
1442FDCA 402(a)(4)14Records 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, ***
409721 CFR 530.20(a)(2)(iv)13Tissue 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, ***
13508FDCA 402(a)(4)13Medication status of animalsFailure 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, ***
1457FDCA 402(a)(4)10Feeding colostrumFeeding colostrum or milk from treated cows to calves intended for slaughter. Specifically, ***
4184FDCA 501(a)(5)10Conditions of useAdministration of a drug for conditions not [specified in its labeling] [prescribed]. Specifically, ***
4186FDCA 402(a)(4)9System for administration of drugsFailure to have a system to control administration of drug treatments to your animals. Specifically, ***
1352121 CFR 530.41(a)9Drugs prohibited for extralabel use in food producing animalA prohibited [drug] [substance] was administered in an extralabel manner to [a] food-producing animal(s). Specifically, ***
138921 CFR 530.11(a)8Withdrawal 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, ***
181121 CFR 225.58(b)(1)8Three 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, ***
4183FDCA 501(a)(5)8Frequency of administrationAdministration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed]. Specifically, ***
209321 CFR 225.102(b)(2)(i)-(iv)6Elements 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, ***
137321 CFR 530.11(a)5Route 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, ***
1446FDCA 402(a)(4)5Hospital penFailure to [identify] [segregate] [quarantine] treated animals. Specifically, ***
146921 CFR 225.20(b)(3)5Pest access minimizedThe building is not constructed to minimize access by [rodents] [birds] [insects] [pests]. Specifically, ***
207621 CFR 225.102(b)(1)5Elements 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, ***
 
413121 CFR 589.2000(c)(1)(i)5RenderersProducts 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, ***
455221 CFR 225.1425Adequate 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, ***
149321 CFR 225.30(b)(4)4Calibration 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, ***
176021 CFR 225.42(b)(6)4Lot 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, ***
185021 CFR 225.58(d)4Assay 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,***
192321 CFR 225.65(b)4Reasonable 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, ***
409421 CFR 530.11(b)4Use in animal feedAn approved drug was used in or on an animal feed in a manner not in accordance with the approved labeling. Specifically, ***
413221 CFR 589.2000(d)(1)4Protein 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, ***
454821 CFR 225.1304Scales and metering devicesThe [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision] [accuracy] for their intended purpose. Specifically, ***
146621 CFR 225.20(b)(2)3Maintained in clean and orderly conditionBuildings are not maintained in a reasonably clean and orderly manner. Specifically, ***
174421 CFR 225.42(b)(6)3Daily inventory record keptFailure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds. Specifically, ***
179221 CFR 225.42(b)(7)3DiscrepanciesFailure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage and theoretical drug usage. Specifically, ***
182121 CFR 225.58(b)(1)3First batch assayNo assay was performed on the first batch for the calendar year of medicated feed requiring a medicated feed mill license. Specifically, ***
195521 CFR 225.80(a)3Appropriate 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, ***
209721 CFR 225.102(b)(4)3Daily 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, ***
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, ***
409921 CFR 530.20(a)(2)(ii)3Extended 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, ***
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, ***
455321 CFR 225.1423Packaged 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 225.1653Establishment 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, ***
1353421 CFR 511.1(b)(7)(ii)3Records: MaintenanceComplete records of the investigation were not maintained. Specifically, ***
1356721 CFR 589.2001(c)(2)(iv)3Label "Do not feed to animals"Failure to conspicuously label [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with the statement "Do not feed to animals". Specifically,***
149121 CFR 225.30(b)(2)2Maintenance reasonably clean & orderlyEquipment is not maintained in a reasonably clean and orderly manner. Specifically, ***
188021 CFR 225.58(e)2Distribution discontinuedDistribution of a medicated feed which failed to meet its labeled drug potency was not discontinued. Specifically, ***
223321 CFR 225.115(b)(1)2Records of oral or written complaintsThe record of each oral or written complaint relating to the safety and effectiveness of a medicated feed fails to include the [date of the complaint] [complainant's name] [complainant's address] [name and lot or control number or date of manufacture] [specific details of the complaint] [correspondence from the complainant and/or memoranda of conversations] [description of all investigations made by the manufacturer] [method of disposition of the complaint]. Specifically, ***
411321 CFR 530.12(e)2Withdrawal, 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, ***
415721 CFR 225.42(b)(7)2Detention 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, ***
454521 CFR 225.1202Vermin and pest infestationBuildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation. Specifically, ***
454721 CFR 225.1302Cleanliness, inspection, cleanoutEquipment 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, ***
455521 CFR 225.1422Use in accord with directionsAll [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled mixing directions. Specifically, ***
455721 CFR 225.1582Investigation 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, ***
456421 CFR 225.1802Bagged 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, ***
1356521 CFR 589.2001(c)(2)(ii)2Renderer's maintaining adequate written proceduresFailure to maintain adequate written procedures specifying how the process of [removing the brain and spinal cord from cattle not inspected and passed for human consumption] [separating animals based on whether or not they are 30 months of age or older] is carried out. Specifically,***
1356821 CFR 589.2001(c)(2)(v)2Marking with readily detected agentFailure to mark [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with an agent that can be readily detected on visual inspection. Specifically,***
1356921 CFR 589.2001(c)(2)(vi)2Tracking records: establish, maintain, make availableFailure to [establish] [maintain] [make available to FDA for inspection and copying] records that are sufficient to track cattle materials prohibited in animal feed to ensure such material is not introduced into animal feed. Specifically,***
126221 CFR 225.10(b)(2)1Evaluation and supervision of employeesFailure to provide an on-going program of evaluation and supervision of employees in the manufacture of medicated feeds. 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, ***
153021 CFR 225.42(b)(1)1Examination of incoming drugsFailure to visually examine incoming drug shipments for [identity] [damage]. Specifically, ***
153521 CFR 225.42(b)(2)1Storage of packaged drugsPackaged drugs are not stored in their original closed containers. Specifically, ***
153921 CFR 225.42(b)(3)1Identification and storage of bulk drugsBulk drugs are not [identified] [stored] in a manner such that their identity, strength, quality, and purity will be maintained. Specifically, ***
157521 CFR 225.42(b)(4)1Integrity and identityFailure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity. Specifically, ***
163821 CFR 225.42(b)(5)1Elements 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, ***
178221 CFR 225.42(b)(7)1Daily 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, ***
193021 CFR 225.65(b)(3)1Sequential productionSequential production of medicated feeds is not done on a predetermined basis designed to prevent unsafe contamination of feeds with residual drugs. Specifically, ***
195321 CFR 225.80(b)(2)1Maintaining 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)1Lack of MRFFailure to have a Master Record File for manufacturing a specific product, which provides the complete procedure for manufacturing a specific product. Specifically, ***
207521 CFR 225.102(b)(1)1Preparation 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, ***
207721 CFR 225.102(b)(1)1MRF kept one year after productionThe Master Record File is not retained for at least one year after production of the last batch or production run of medicated feed to which it pertains. Specifically, ***
209221 CFR 225.102(b)(2)1Production records kept one yearProduction record(s), for each batch or run of medicated feed produced are not kept on the premises for at least one year. Specifically, ***
218121 CFR 226.11Automated equipment - assurance of proper performanceAdequate [inspection and checking] [quality control] procedures are not used to assure proper performance of [precision] [automatic] [mechanical] [electronic] equipment used in the production of Type A medicated articles. Specifically, ***
225121 CFR 226.301Design suitable to facilitate maintenance and operationEquipment used in the [manufacture] [processing] [packaging] [bulk shipment] [labeling] [holding] [control] of Type A medicated articles is not of suitable design to facilitate maintenance and operation for its intended purpose. Specifically, ***
237921 CFR 226.40(e)1Cleaning to prevent contamination of Type A articlesFailure to use adequate procedures for cleaning of those parts of equipment which come into contact with drug components of Type A medicated articles, to avoid contamination of Type A medicated articles. Specifically, ***
410121 CFR 530.20(a)(1)1Approved drug availableFailure to determine that an approved animal drug was clinically ineffective for its intended use in a food-producing animal, prior to prescribing or dispensing an approved human or animal drug contrary to the drug's labeling. Specifically, ***
410821 CFR 530.12(a)1Name and address - drug dispensed by veterinarianFailure to provide labeling showing the name and address of the prescribing veterinarian 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, ***
411821 CFR 530.13(b)(3)1Outside 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, ***
413721 CFR 589.2000(d)(1)1Maintaining 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, ***
414721 CFR 589.2000(e)(1)1Written 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, ***
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, ***
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, ***
1353121 CFR 511.1(b)(7)(iii)1Reports: Adequate and TimelyThe investigator did not furnish adequate and timely reports of the investigation to the sponsor. Specifically, ***
13541FDCA 501(a)(5)1Use of veterinary prescription drugs without a prescriptionAdministration of veterinary prescription drugs was performed without the lawful written or oral order of a licensed veterinarian. Specifically, ***
1356621 CFR 589.2001(c)(2)(iii)1Cross contamination of cattle materialsFailure to provide for measures to avoid cross-contamination by use of [separate equipment] [separate containers] once cattle materials prohibited in animal feed have been separated from other cattle materials. Specifically,***

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Biologics

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Biologics7621 CFR 606.100(b)151Maintained 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)48Thorough 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,***
16021 CFR 606.160(a)(1)40Person 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, ***
15421 CFR 606.160(a)(1)34Concurrent 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, ***
15521 CFR 606.160(b)25Required recordsFailure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records. Specifically, ***
15921 CFR 606.160(a)(1)18Legibility and indelibilityRecords are [illegible] [not indelible]. Specifically, ***
6721 CFR 606.65(e)17Following manufacturer's instructionsFailure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer. Specifically, ***
922521 CFR 606.17117Biological 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, ***
3121 CFR 606.20(b)15Qualifications 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, ***
7821 CFR 606.100(c)15Record 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, ***
1503021 CFR 606.60(b)15Equipment calibration frequencyEquipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood and blood components is not observed, standardized and calibrated with at least the frequency required. Specifically, ***
9421 CFR 606.100(b)(15)10Schedules and procedures for equipment & calibrationThe standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration. Specifically, ***
442521 CFR 606.60(a)10Equipment observed, standardized, calibratedDue to inadvertent temperature exposure Source Plasma was required to be relabeled as "Source Plasma Salvaged," however, the original label was not covered with [a complete new label containing the appropriate information] [a partial label (with the appropriate new information) covering the incorrect information regarding storage temperature.]Specifically, ***
20821 CFR 640.3(a)(1)9Donor 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, ***
4121 CFR 606.40(a)(1)8Provide 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)8Provide 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, ***
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, ***
1220221 CFR 606.170(a)7Adverse Reaction - InvestigationsA thorough investigation of each reported adverse reaction was not made. Specifically,
5721 CFR 606.60(a)6Maintain 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, ***
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, ***
3521 CFR 606.405Clean & orderlyFailure to maintain facilities in a clean and orderly manner. Specifically, ***
22421 CFR 640.4(f)5Arm preparationThe phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood. Specifically, ***
923521 CFR 630.6(c)5DocumentationFailure to [document that you have successfully notified a deferred donor] [document that you have made reasonable attempts to notify a deferred donor]. Specifically, ***
924321 CFR 630.6(a)5NotificationFailure to make reasonable attempts to notify a donor who has been [deferred based on the results of tests for evidence of communicable disease agent(s)] [determined not be to suitable as a donor based on suitability criteria]. Specifically, ***
959621 CFR 640.3(a)5Donor 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, ***
7721 CFR 606.100(b)4Written SOPs available for use by personnelFailure to make available written procedures for use by personnel in the areas where the procedures are performed. Specifically, ***
8021 CFR 606.100(b)(1)4Donor criteriaThe standard operating procedure fails to include written descriptions of criteria used to determine donor suitability, including acceptable medical history criteria. Specifically, ***
8921 CFR 606.100(b)(10)4Controlling 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, ***
14221 CFR 606.140(a)4Establishment 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, ***
15021 CFR 606.151(e)4Procedures 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, ***
15821 CFR 606.160(e)4Unsuitable donorsA record is not available from which unsuitable (deferred) donors may be identified so that products from such individuals will not be distributed. Specifically, ***
22721 CFR 640.4(h)4Storage 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, ***
23821 CFR 640.11(a)4General requirements - storageFailure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing. Specifically, ***
25521 CFR 640.314Donor suitabilityFailure to ensure that [whole blood] [plasmapheresis] donors meet suitability criteria. Specifically, ***
904421 CFR 600.10(b)4Personnel capabilitiesEquipment 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, ***
907721 CFR 600.12(a)4Maintenance - completenessThe [manufacturing] [distribution] records [are not legible and indelible] [do not detail the various steps of manufacture of the product]. Specifically, ***
908621 CFR 600.14(a)(1)4Who must report - manufacturerFailure to submit [a] biological deviation [report] [reports]. Specifically, ***
1220321 CFR 606.170(a)4Adverse Reaction- Reports of InvestigationsWritten reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained.Specifically, 
8121 CFR 606.100(b)(2)3Donor 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, ***
8821 CFR 606.100(b)(9)3Written 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, ***
324621 CFR 640.613Obtaining consent in an appropriate mannerFailure to explain to the prospective Source Plasma donor [by a qualified physician] the [hazards of the plasmapheresis procedure] [risks of a hemolytic transfusion reaction] [hazards involved if the donor is hyperimmunized]. Specifically, ***
923421 CFR 630.6(c)3Notification w/in 8 weeksFailure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor is deferred or determined not to be suitable for donation. Specifically, ***
3821 CFR 606.40(b)2Adequate lighting, ventilation, and screeningFailure to provide adequate [lighting] [ventilation] [screening of open windows and doors]. 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, ***
8321 CFR 606.100(b)(4)2Relate products to the donorThe standard operating procedure fails to include a written description of the method for accurately relating the product(s) to the donor. Specifically, ***
8521 CFR 606.100(b)(6)2Methods 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, ***
9121 CFR 606.100(b)(12)2Criteria 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, ***
10621 CFR 606.120(a)2Separation of labeling operationsFailure to separate labeling operations [physically] [spatially] from other operations in a manner adequate to prevent mix-ups. 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, ***
12121 CFR 606.121(c)(2)2Name, address, registration numberThe container label fails to include the [name] [address] [registration number] [the license number of each manufacturer, for a licensed product]. Specifically, ***
16121 CFR 606.160(a)(2)2Determination 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, ***
16521 CFR 606.170(a)2Adverse 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, ***
16721 CFR 606.170(b)2Adverse 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, ***
19821 CFR 640.2(c)(3)2Blood not stored between 1-6 deg / shipped 1-10 degReissued blood has not been [stored continuously at 1 to 6 C] [shipped between 1 and 10 C]. Specifically, ***
21521 CFR 640.3(b)(6)2Qualifications 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, ***
21821 CFR 640.3(c)(2)2History of viral hepatitis - close contactAn individual was used as a source of Blood who had a history of close contact within twelve months of donation with an individual having viral hepatitis. Specifically, ***
24121 CFR 640.11(b)2General 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, ***
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, ***
25321 CFR 640.25(b)(4)2Corrective actionFailure to [take immediate corrective action] [maintain a record of corrective action] when the quality control testing for platelets does not meet the prescribed requirements. Specifically, ***
37621 CFR 640.1202Alternative proceduresFailure 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, ***
324521 CFR 640.612Explanation of hazardsFailure to request from CBER and obtain approval for exceptions or alternatives to requirements regarding [blood] [blood components] [blood products]. Specifically, ***
325821 CFR 640.63(d)2Unreliable answersFailure to have donor suitability determined [by a qualified licensed physician or trained persons under his supervision]. Specifically, ***
345321 CFR 601.12(c)2Moderate changes to an approved applicationFailure to [submit a supplement] [receive supplement approval from FDA] prior to distributing product made using the change. Specifically, ***
908721 CFR 600.14(a)(1)2Who 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, ***
925621 CFR 610.412Donor 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, ***
3221 CFR 606.20(c)1Exclusion of certain personsFailure to exclude persons whose presence can adversely affect the safety and purity of the products from areas where the [collection] [processing] [compatibility testing] [storage] [distribution] of blood or blood components is conducted. 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, ***
4721 CFR 606.40(a)(7)1Provide space for collection, processing, testing, dist, etcFailure to provide adequate space for the orderly [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components to prevent contamination. Specifically, ***
4921 CFR 606.40(a)(9)1Provide space for all packaging, labeling, & finishing ops.Failure to provide adequate space for the orderly conduction of all [packaging] [labeling] [other finishing] operations. 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, ***
7521 CFR 606.100(a)1SOP complianceFailure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640. Specifically, ***
8421 CFR 606.100(b)(5)1Accurate 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, ***
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, ***
10121 CFR 606.110(a)1Supervision of qualified physicianPerformance of [plateletpheresis] [leukapheresis] not under the supervision of a qualified licensed physician who was aware of the health status of the donor. Specifically,***
10221 CFR 606.110(a)1Written certificationPerformance of [plateletpheresis] [leukapheresis] without a qualified licensed physician certifying in writing that the donor's health permitted [plateletpheresis] [leukapheresis]. Specifically,***
11021 CFR 606.120(b)(2)1Destruction of obsolete labelsFailure to destroy stocks of obsolete labels. Specifically, ***
12321 CFR 606.121(c)(4)1Expiration dateThe container label fails to include the [expiration date, including the day, month, and year] [hour of expiration, for product less than 72 hours expiration]. Specifically, ***
12821 CFR 606.121(c)(7)1Storage temperature in CelsiusThe container label fails to include the recommended storage temperature (in degrees Celsius). Specifically, ***
13021 CFR 606.121(c)(9)1Infectious agent statementThe container label fails to contain the statement: "This product may transmit infectious agents." Specifically, ***
14321 CFR 606.140(b)1Provisions to monitor lab test procedures & instrumentsFailure to establish adequate provisions for monitoring the [reliability] [accuracy] [precision] [performance] of laboratory test procedures and instruments. 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, ***
14521 CFR 606.151(a)1Method of collecting and identifying blood samplesFailure of standard operating procedures for compatibility testing to include the method of collecting and identifying the blood samples of recipients to ensure positive identification. Specifically, ***
15621 CFR 606.160(c)1Assignment 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, ***
15721 CFR 606.160(d)1Retention periodFailure to retain records [for 5 years after the records of processing have been completed] [for 6 months after the latest expiration date for the individual product] [indefinitely where there is no expiration date]. Specifically, ***
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, ***
21121 CFR 640.3(b)(2)1Qualifications 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, ***
21721 CFR 640.3(c)(1)1History of viral hepatitisAn individual was used as a source of blood who had a history of viral hepatitis after the 11th birthday. Specifically, ***
22521 CFR 640.4(f)1Closed systemThe blood is [not collected by aseptic methods in a sterile system] [collected using a vented system which fails to protect the blood against contamination]. Specifically, ***
23621 CFR 640.5(e)1Testing - inspectionFailure to [visually inspect blood during storage and immediately prior to issue for] [prevent issuance of blood found to have] abnormal color, physical appearance, or indication or suspicion of microbial contamination. Specifically, ***
25121 CFR 640.25(b)1Quality 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, ***
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, ***
33321 CFR 640.64(e)1Prevention of contaminationThe phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood. Specifically, ***
33521 CFR 640.65(b)(1)(i)1Serological testFailure to draw from each donor [on the day of the first medical exam or plasmapheresis] [at least every 4 months] a sample of blood tested for [syphilis] [total plasma or serum protein determination] [serum protein electrophoresis or equivalent test]. Specifically, ***
35321 CFR 640.68(b)1Final containerThe final containers used for Source Plasma [are entered prior to issuance for a purpose other than filling with the plasma] [are colored] [are not hermetically sealed] [do not permit clear visibility of the contents] [interact with the plasma contents under conditions of storage and use so as to alter the safety, quality, purity, or potency] [provide inadequate protection against external factors that may cause deterioration or contamination] [are not identified prior to filling by number or other symbol which will relate them to the donors]. 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, ***
36821 CFR 640.72(d)1Donor 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, ***
324821 CFR 640.63(a)1Determining donor suitabilityFailure to present the hazards and risks of plasmapheresis in such a manner that intelligent and informed consent can be given by the prospective Source Plasma donor. Specifically, ***
345221 CFR 601.12(b)1Major changes to an approved applicationFailure to consider as unsuitable any donor who does not appear to be providing reliable answers to medical history questions. Specifically, ***
345421 CFR 601.12(d)1Minor changes to an approved applicationFailure to submit a supplement [at least 30 days] prior to distributing product made using the change. Specifically, ***
354321 CFR 610.46(a)(1)1Quarantine and notificationMinor changes were made to the product or process, but were not reported in an annual report. Specifically, ***
361821 CFR 606.100(b)(19)1Procedure for HIV lookbackWhen 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, ***
364221 CFR 640.76(c)1Source Plasma - Re-labelingThere 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, ***
907821 CFR 600.12(a)1Maintenance - tracingRecords are not maintained in a manner which allows steps in the [manufacture] [distribution] of product to be traced. Specifically, ***
908921 CFR 600.14(c)1When to reportBiological product deviations [were] [are] not reported within the 45 calendar day timeframe. Specifically, ***
921921 CFR 606.100(b)(20)1Donor deferralThe standard operating procedure fails to include a written description of the donor deferral process. 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, ***
923921 CFR 630.6(b)(4)1Follow up and counselingFailure to provide appropriate information concerning medical follow-up and counseling. Specifically, ***
926621 CFR 610.40(e)1Further testingFailure to further test each donation found to be reactive to a screening test. 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, ***
928821 CFR 640.211Suitability of donorAll [plasmapheresis] [plateletpheresis] donors did not meet the criteria for suitability. Specifically, **
931421 CFR 640.65(b)(2)(i)1Physician review of resultsFailure to have the accumulated laboratory data reviewed by a qualified licensed physician within 21 days after the sample was drawn to determine whether or not the donor may continue in the program. Specifically, ***
931721 CFR 640.65(b)(8)1TimingCollection occurred [less than two days apart] [more than twice in a 7-day period]. Specifically, ***
934621 CFR 610.111GeneralFailure to perform an approved general safety test. Specifically, ***

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Parts 1240 and 1250

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Parts 1240 and 1250703621 CFR 1250.6747Prevention 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, ***
656021 CFR 1250.32(a)20ContaminationNot all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils]. Specifically, ***
655821 CFR 1250.30(d)19Plumbing design, installation, maintenancePlumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils]. Specifically, ***
703221 CFR 1250.6314Prevention 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, ***
655221 CFR 1250.2813Handling 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)13Storage and handling after bactericidal treatmentFailure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse. Specifically, ***
658121 CFR 1250.38(b)12Soap, sanitary towels, waterHand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water]. Specifically, ***
705121 CFR 1250.75(a)11Contamination of passenger stationsFailure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations]. Specifically, ***
657921 CFR 1250.38(a)7Suitable design and constructionFailure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees. Specifically, ***
705321 CFR 1250.75(b)7Sanitary sewers or alternative methodsFailure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal]. Specifically, ***
709021 CFR 1250.82(e)7Backflow prevention - generalLack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment]. Specifically, ***
655521 CFR 1250.30(a)6Clean 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, ***
656421 CFR 1250.33(a)6Maintained in good repairNot all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are maintained in good repair. Specifically, ***
656921 CFR 1250.33(b)6Equipment kept cleanFailure to keep all equipment clean. Specifically, ***
658021 CFR 1250.38(b)6SignsSigns 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)6Backflow protectionA water system not protected against backflow. Specifically, ***
708921 CFR 1250.82(d)6Identification marks on tanks and pipingNot all [tanks] [piping] bear clear marks of identification. Specifically, ***
656521 CFR 1250.33(a)4Adequate 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)4Cleaning 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, ***
652121 CFR 1240.803Non-potable water usedNon-potable water is used for [drinking] [culinary] purposes. 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, ***
659021 CFR 1250.42(a)3Complete and closedA water system which is not [complete] [closed] from the filling ends to the discharge taps (except for protected vent openings). Specifically, ***
661221 CFR 1250.503Designed to permit ready cleaningLack of design of [toilet] [lavatory] facilities so as to permit ready cleaning. Specifically, ***
709221 CFR 1250.82(f)3Cleaning, disinfecting, flushingFailure to [clean] [disinfect] [flush] a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases. Specifically, ***
654921 CFR 1250.272Storage of perishablesFailure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared or kept hot for serving. Specifically, ***
657221 CFR 1250.342ThermometersFailure to equip each refrigerator with a thermometer located in the warmest region thereof. Specifically, ***
658421 CFR 1250.392Containers - watertight, readily cleanable, non-absorbentGarbage containers are not [watertight] [readily cleanable] [non-absorbent]. Specifically, ***
659321 CFR 1250.42(b)2Connections 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, ***
705521 CFR 1250.75(b)2Equipment 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, ***
708121 CFR 1250.82(a)2Separate systemsThe potable water system is [not separate and distinct from other water systems] [used for other purposes]. 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, ***
657721 CFR 1250.35(b)1Open lesion or infected woundFailure to exclude persons with an open lesion or infected wound on the exposed portion of the body from [preparation] [handling] [serving] of [beverages] [food]. Specifically, ***
658521 CFR 1250.391Containers - close-fitting coversGarbage containers lack close-fitting covers. Specifically, ***
704121 CFR 1250.70(a)1Adequate 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, ***
704221 CFR 1250.70(a)1Clean and sanitaryFailure to maintain [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees in a clean and sanitary condition. 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, ***
708721 CFR 1250.82(c)1Potable water tanks -- openingsA potable water tank is equipped with a [manhole] [overflow] [vent] [device for measuring depth of water] and [no] [inadequate] provision is made to prevent entrance into the tank of contaminating substances. Specifically, ***

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Human tissue for transplantation

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Human tissue for transplantation1233621 CFR 1271.180(a)29Procedures 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, ***
1222121 CFR 1271.47(a)27Procedures 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, ***
1221321 CFR 1271.47(a)18Donor 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, ***
1227721 CFR 1271.75(a)(1)17Risk 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, ***
1224721 CFR 1271.55(d)(2)14Accurate, indelible, legibleDonor eligibility records are not [accurate] [indelible] [legible]. Specifically, ***
1241621 CFR 1271.260(e)14Storage temperatures recorded, maintainedStorage temperatures of HCT/Ps were not [recorded] [maintained]. Specifically, ***
1243321 CFR 1271.265(f)14Return 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, ***
1223021 CFR 1271.50(a)11Responsible 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, ***
1222921 CFR 1271.50(a)10Determination based on screening and testingHCT/P donors were not determined to be eligible based on the results of donor screening and testing. Specifically, ***
1228621 CFR 1271.80(b)10Specimen collections not timelyDonor specimens used for testing of communicable disease agents were not collected at the appropriate time. Specifically, ***
1224621 CFR 1271.55(d)(1)(iii)9Documentation--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, ***
1230121 CFR 1271.150(c)(1)(iii)8Ensurane 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, ***
1249221 CFR 1271.85(a)8Infection with communicable disease agentsDonors were not tested for evidence of infection with communicable disease agents. Specifically, ***
1228221 CFR 1271.75(d)7Donors with risks not determined ineligibleDonors were not determined to be ineligible that had [risk factors or clinical evidence of communicable disease agents] [communicable disease risks associated with xenotransplantation]. Specifically, ***
1239821 CFR 1271.230(a)7Validation & 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, ***
1222221 CFR 1271.47(a)6Design of procedures to ensure complianceProcedures were not designed to ensure compliance with the donor eligibility requirements. Specifically, ***
1222321 CFR 1271.47(b)6Review and approval of proceduresDonor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation. Specifically, ***
1245721 CFR 1271.320(a)6Procedures 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, ***
1249621 CFR 1271.85(b)(2)6SOP 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. ***
1223721 CFR 1271.55(a)(3)5Summary--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, ***
1228321 CFR 1271.75(e)5Abbreviated 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)5Kits 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, ***
1232221 CFR 1271.160(b)(4)5Training of personnelThe quality program has not ensured the proper training and education of personnel involved in core GTP activities. Specifically, ***
1232621 CFR 1271.160(c)5Quality audits performed periodicallyPeriodic quality audits of activities related to core CGTP requirements have not been performed. Specifically, ***
1236221 CFR 1271.195(b)5Corrective actionsAppropriate corrective actions were not taken related to the inspections of environmental control systems. Specifically, ***
1236921 CFR 1271.200(b)5Procedures inadequateProcedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, ***
1237021 CFR 1271,200(c)5Calibration 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, ***
1239921 CFR 1271.230(a)5Process 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, ***
1241121 CFR 1271.260(a)5Contamination, 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, ***
1242921 CFR 1271.265(d)5Shipping conditions appropriateAppropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P. Specifically, ***
1243121 CFR 1271.265(e)5Procedures 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, ***
1225021 CFR 1271.55(d)(4)4Ten year retentionRecords pertaining to HCT/Ps were not retained [at least 10 years after the date of administration] [at least 10 years after the date of distribution, disposition, or expiration, whichever was latest when the date of administration of the HCT/P was unknown]. Specifically, ***
1233421 CFR 1271.170(c)4Trained or re-trained as necessaryPersonnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities. Specifically, ***
1243621 CFR 1271.270(a)4Accurate, indelible, legibleRecords were not [accurate] [indelible] [legible]. Specifically, ***
1243721 CFR 1271.270(a)4Records 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, ***
1223621 CFR 1271.55(a)(2)3Eligibility 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, ***
1224121 CFR 1271.55(b)(4)3Reasons for ineligibility on summaryThe summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the ineligibility. Specifically, ***
1227021 CFR 1271.65(a)3Improper release prevention--storage, I.D.HCT/Ps from ineligible donors are not [stored] [identified] in a manner to prevent improper release. Specifically, ***
1227221 CFR 1271.65(b)(2)3Labeled re: biohazard, risks, test resultsHCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with [the Biohazard legend] [a statement warning of communicable disease risks] [a statement warning of the reactive test results]. Specifically, ***
1231021 CFR 1271.160(a)3All 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, ***
1231121 CFR 1271.160(b)(1)3Ensuring 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, ***
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, ***
1232421 CFR 1271.160(b)(6)3Deviations--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, ***
1233821 CFR 1271.180(b)3Review and approval-responsible personProcedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation. Specifically, ***
1235621 CFR 1271.195(a)3Adequate 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, ***
1235921 CFR 1271.195(a)(3)3Aseptic processing---cleaning, disinfectingEnvironmental controls do not provide for adequate [cleaning] [disinfecting] of [rooms] [equipment] to ensure aseptic processing. Specifically, ***
1236521 CFR 1271.195(d)3Documentation not maintainedDocumentation of environmental control and monitoring activities was not maintained. Specifically, ***
1237521 CFR 1271.210(a)3Use 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, ***
1241421 CFR 1271.260(d)3Corrective actionsCorrective actions were not [performed] [documented] when proper storage conditions were not met. Specifically, ***
1241721 CFR 1271.260(e)3Periodic review of temperaturesRecorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits. Specifically, ***
1244721 CFR 1271.290(b)3Establishing 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, ****
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, ***
1222421 CFR 1271.47(c)2Availability 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, ***
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, ***
1224921 CFR 1271.55(d)(3)2Records not made available to FDARequired donor eligibility records were not made available for authorized inspection or upon request by FDA. Specifically, ***
1227821 CFR 1271.75(a)(2)2Risks associated with xenotransplantationDonors were not screened by a review of relevant medical records for disease risks associated with xenotransplantation. 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, ***
1230921 CFR 1271.160(a)2Program 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, ***
1232021 CFR 1271.160(b)(3)2Actions 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)2Deviations--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, ***
1232921 CFR 1271.160(d)2Documentation/approval prior to implementationComputer software [validation] [verification] activities and results have not been [documented] [approved] prior to implementation. Specifically, ***
1235121 CFR 1271.190(d)(1)2Procedures for cleaning, sanitationProcedures for facility cleaning and sanitation were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, ***
1236821 CFR 1271.200(a)2Capable of valid resultsEquipment used for [inspection] [measuring] [testing] was not capable of producing valid results. Specifically, ***
1238521 CFR 1271.150(c)(2)2Responsibility for review before distributionHCT/Ps were determined to meet all release criteria and made available for distribution without review of [manufacturing] [tracking] records to determine that all applicable requirements were met. Specifically, ***
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, ***
1242421 CFR 1271.265(c)(1)2Release criteria verified, documentedRelease criteria were not [verified] [documented] to have been met through a review of manufacturing and tracking records before HCT/Ps were made available for distribution. Specifically, ***
1243221 CFR 1271.265(e)2Documentation 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, ***
1243521 CFR 1271.270(a)2Records maintained concurrentlyRecords were not maintained concurrently with the performance of each step. Specifically, ***
1245321 CFR 1271.290(e)2Documenting 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, ***
1245821 CFR 1271.320(b)2Designated complaint fileComplaints received were not maintained in a file designated for complaints. Specifically, ***
1247221 CFR 1271.350(b)(1)2Deviations not investigatedHCT/P deviations related to distributed HCT/Ps for which the establishment performed a manufacturing step were not investigated. 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, ***
1502021 CFR 1271.200(e)2Documentation of maintenance and cleaningDocumentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained. Specifically, ***
1222521 CFR 1271.47(d)1Departures: recording and justifyingDepartures from donor eligibility procedures relevant to preventing risks of communicable disease transmission were not [recorded] [justified]. Specifically, ***
1223121 CFR 1271.50(b)(1)1Donor screening standardsDonor screening of HCT/P donors considered eligible indicated that the donor was not free of [risk factors for infection due to communicable disease agents] [clinical evidence of infection due to communicable disease agents] [risk factors associated with xenotransplantation]. Specifically, ***
1223421 CFR 1271.55(a)(1)1Identification code affixed to containerAfter the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a distinct identification code affixed to the HCT/P container. Specifically, ***
1223821 CFR 1271.55(b)(1)1Statement 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, ***
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, ***
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, ***
1225721 CFR 1271.60(c)(2)1Records stating determination not completedHCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not accompanied by records that stated the donor-eligibility determination had not been completed. 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, ***
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, ***
1228821 CFR 1271.80(c)1Manufacturer instructions not followedTesting for communicable disease agents was not performed in accordance with the manufacturer's instructions. Specifically, ***
1229021 CFR 1271.80(d)(1)1Reactive tests--not determined ineligibleDonors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible. Specifically, ***
1229121 CFR 1271.80(d)(2)1Plasma diluted test specimensDonors were not determined to be ineligible whose communicable disease test specimens were plasma diluted, and [the donor was not tested using a specimen which was taken before transfusion or infusion and within seven days before recovery of the cells or tissue] [an appropriate algorithm was not used to determine that the plasma dilution did not affect the test results]. Specifically, ***
1231421 CFR 217.160(b)(2)(iii)1Risk 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, ***
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, ***
1232321 CFR 1271.160(b)(5)1Monitoring systemsThe quality program has not established and maintained appropriate monitoring systems. Specifically, ***
1233221 CFR 1271.170(b)1Qualifications lackingPersonnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions. Specifically, ***
1233321 CFR 1271.170(b)1Not qualified, authorized for functionsPersonnel perform functions for which they are not [qualified] [authorized]. Specifically, ***
1233921 CFR 1271.180(c)1Availability 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, ***
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, ***
1234321 CFR 1271.190(a)1State of repairFacilities were not maintained in a good state of repair. Specifically, ***
1234421 CFR 1271.190(a)1Lighting, ventilation, plumbingFacilities did not provide adequate [lighting] [ventilation] [plumbing] [drainage] [access to sinks and toilets] to prevent the introduction, transmission or spread of communicable disease. 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, ***
1235421 CFR 1271.190(d)(2)1Documentation of activitiesDocumentation of facility cleaning and sanitation activities was not maintained. Specifically, ***
1235721 CFR 1271.195(a)(1)1Temperature and humidity controlsEnvironmental controls do not provide for adequate control of [temperature] [humidity]. Specifically, ***
1236121 CFR 1271.195(b)1Periodic inspectionEnvironmental control systems are not periodically inspected to verify adequate and proper function. Specifically, ***
1236321 CFR 1271.195(c)1Monitoring--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, ***
1236421 CFR 1271.195(c)1Monitoring-microorganisms where appropriateEnvironmental conditions were not monitored for microorganisms. Specifically, ***
1237121 CFR 1271.200(a)1Cleaned, sanitized per established schedulesEquipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained] according to established schedules. Specifically, ***
1237321 CFR 1271.200(d)1Inspected routinelyEquipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to maintenance schedules]. Specifically, ***
1237721 CFR 1271.210(c)1In-house reagent productionThe processes used for the production of in-house reagents were not [validated] [verified]. 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, ***
1238221 CFR 1271.210(d)(3)1Lot documentation maintainedDocumentation of the lot of [supplies] [reagents] used in the manufacture of each HCT/P 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, ***
1240221 CFR 1271.230(c)1Changes to validated processA validated process that was changed was not [reviewed] [evaluated] [revalidated]. Specifically, **
1240521 CFR 1271.250(a)1Controlling the labeling of HCT/PsProcedures to control the labeling of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
1240721 CFR 1271.250(b)1Verification of label accuracy, legibility, integrityLabeling procedures did not include verification of label [accuracy] [legibility] [integrity]. 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, ***
1244821 CFR 1271.290(c)1Identification codeHCT/Ps were not assigned a distinct identification code that relates the HCT/Ps to the donor and all records related to the product. Specifically, ***
1245121 CFR 1271.290(c)1Relating new code to old codeWhen new identification codes are assigned to HCT/Ps used at this establishment in place of distinct identification codes assigned to the same HCT/Ps by another establishment, procedures for relating the new codes to the old codes have not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
1245421 CFR 1271.290(f)1Timely informing of consigneesConsignees were not informed in writing at or before the time of distribution of an HCT/P, of [the requirements related to HCT/P tracking] [the tracking system you have established and are maintaining]. Specifically, ***
1246021 CFR 1271.320(c)1Review and evaluation, report to FDAComplaints were not reviewed and evaluated to determine [if the complaint is related to an HCT/P deviation or adverse reaction] [whether a report to FDA is required]. 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, ***
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, ***
1247521 CFR 1271.370(a)1Clear and accurate labelHCT/Ps made available for distribution were not labeled [clearly] [accurately]. Specifically, ***
1247821 CFR 1271.370(b)(3)1Expiration date on labelHCT/Ps made available for distribution were not labeled with the expiration date of the product. 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, ***
1249021 CFR 1271.85(b)(1)1Cell-associated CDDonors of leukocyte-rich cells or tissues were not tested for cell-associated communicable diseases. Specifically, ***

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Radiological health

Center NameCite IdRef NoFrequencyShort DescriptionLong Description
Radiological health500721 CFR 1002.137Failure to submitYou did not submit an annual report [by the September 1 deadline] for products requiring one. Specifically, ***
500521 CFR 1002.114Failure to submitYou did not submit a required supplemental report, prior to the introduction of the product into commerce, for a new or modified model within a model or chassis family. Specifically, ***
570021 CFR 1002.104Failure 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, ***
501221 CFR 1003.10(a)2FDA not notified of defect or noncomplianceYou did not notify the Secretary, in accordance with 21 CFR 1003.20, of an electronic product which [was defective] [failed to comply with an applicable Federal standard] which you [produced] [assembled] [imported] [distributed]. Specifically, ***
503221 CFR 1010.2(b)2Certification 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, ***
503421 CFR 1010.2(c)2Certification not based on adequate test/testing programCertification was not based upon [a test, in accordance with the standard] [a testing program in accordance with good manufacturing practices]. Specifically, ***
521321 CFR 1040.11(c)2Demonstration laser productsEach demonstration laser product [does not comply with all of the applicable requirements for a Class I, IIa, II, or IIIa laser product] [prevent human access to laser radiation in excess of the accessible emission limits of Class I, IIa, II or IIIa]. Specifically, ***
581321 CFR 1002.30(a)(2)2Methods, devices, procedures for testingYou have not [established] [maintained] records of the [methods] [devices] [procedures] used in tests for electronic product radiation safety. Specifically, ***
500621 CFR 1002.121Not submitted prior to introductionYou did not submit an abbreviated report, required by 21 CFR 1002.1, prior to introduction of the product. Specifically, ***
500821 CFR 1002.20(a)1Failure to reportYou did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you. Specifically, ***
501321 CFR 1003.10(b)1Dealers, distributors, purchasers not notifiedYou did not notify [all of] the [dealers] [distributors] [purchasers] [subsequent transferees] of an electronic product which [was defective] [failed to comply with an applicable Federal standard] . Specifically, ***
501921 CFR 1004.11CAP not submittedIn a situation where an electronic product you have manufactured [fails to comply with an applicable Federal standard] [has a defect subject to the notification requirements of 21 CFR 1003.10(b)], you have not submitted a plan to the Secretary to [bring the product into conformity with the standard] [remedy the defect] without charge (including reimbursement of any transportation expenses), replace the product with a like or equivalent one which [complies with the standard] [is free of defects relating to safety of its use], or refund the cost of the product to the purchaser. Specifically, ***
503121 CFR 1010.2(a)1Lack of certification of conformanceFailure to furnish to the [dealer] [distributor], at the time of delivery of a product, a certification that the product conforms to all applicable standards. Specifically, ***
504221 CFR 1010.3(a)1ID label or tagAn identification label or tag is not [in the English language] [permanently affixed or inscribed] [legible] [readily accessible to view when the product is fully assembled for use]. Specifically, ***
514621 CFR 1040.10(f)(2)(iii)(a)1No multiple safety interlockA laser product was not provided with either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing, when failure of a single interlock allowed human access to a level of laser radiation in excess of the accessible emission limits of Class IIIa. Specifically, ***
515021 CFR 1040.10(f)(3)1Remote interlock connectorEach laser system classified as a Class IIIb or Class IV laser product [was not incorporated with a readily available remote interlock connector having an electrical potential difference of no greater than 130 root-mean-square volts between terminals.] [had no means to prevent, when the terminals of the connector are not electrically joined, human access to all laser and collateral radiation from the laser product in excess of the accessible emission limits of Class I and table VI.] Specifically, ***
517121 CFR 1040.10(g)(3)1Class IV "Danger" labelEach Class IV laser product does not have affixed a label [bearing the DANGER logotype specified in the regulation] [bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION" in the position specified in the regulation] [bearing the wording "CLASS IV LASER PRODUCT" in the position specified in the regulation]. Specifically, ***
519721 CFR 1040.10(h)(1)(i)1User information, adequate instructionsAdequate instructions for each laser product were not provided or caused to be provided for [assembly] [operation] [maintenance] [clear warnings concerning precautions to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits specified in the regulations] [a maintenance schedule necessary to keep the product in compliance with the standard]. Specifically, ***
520321 CFR 1040.10(h)(2)(i)1Reproduction of affixed informationThe manufacturer did not provide or cause to be provided in all [catalogs] [specification sheets] [descriptive brochures] pertaining to each laser product, a legible reproduction of [the class designation] [the warning] [the information required for positions 1, 2, and 3 of the applicable logotype] required b to be affixed to the product. Specifically, ***
521121 CFR 1040.11(b)1Surveying, leveling, alignment laser productsEach [surveying] [leveling] [alignment] laser product [does not comply with all of the requirements for a Class I, IIa, II, and IIIa laser product] [does not prevent human access to laser radiation in excess of the accessible emission limits of Class IIIa]. Specifically, ***
546821 CFR 1020.30(j)1Mandatory warning on control panelThe required warning statement "Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed" [is not present on the control panel containing the main power switch] [is not legible and accessible to view]. Specifically, ***
547521 CFR 1020.30(m)(1)1Half-value layer--amount of filtrationWith reference to Table 1 appearing in Title 21 CFR 1020.30(m), the half-value layer (HVL) of the useful beam for a given x-ray tube potential was less than the appropriate value shown in table 1 [under "Specified dental systems" for the dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980] [under "Other X-ray systems" for all x-ray systems other than specified dental systems]. Specifically, ***
547621 CFR 1020.30(m)(1)1Filtration located in useful beam during exposureA positive means was not provided to insure that at least the minimum filtration needed to achieve beam quality requirements was in the useful beam during each exposure. Specifically, ***
547921 CFR 1020.30(n)1Compliance measurementCompliance with the aluminum equivalence limits was not determined by x-ray measurements made [at a potential of 100 kilovolts peak] [with an x-ray beam that has a half-value layer of 2.7 millimeters of aluminum]. Specifically, ***
559821 CFR 1020.30(e)1Word "model" or "type" permanent and legibleThe word "model" or "type" [does not appear as part of the manufacturer's required identification of certified x-ray components] [is not permanently inscribed or affixed on the component] [is not legible and accessible to view]. Specifically, ***
568721 CFR 1002.10(j)1Warning signs, labels, instructionsA product report did not describe for each model all [warning signs] [labels] [instructions for installation, operation, and use] that relate to electronic product radiation safety. Specifically, ***
578321 CFR 1003.201Failure to confirm in writing to FDAYou did not confirm in writing the notification to the Secretary required by 21 CFR 1003.10(a) for an electronic product which [has a defect] [does not comply with an applicable Federal standard]. Specifically, ***
580621 CFR 1002.111Lack of required elementsA supplemental product report for a new or modified model did not describe changes in the information in the previously submitted product report that affect [actual or potential radiation emission] [the manner of compliance with a standard or manner of testing for radiation safety].
581221 CFR 1002.30(a)(2)1Results of testsYou have not [established] [maintained] records of the results of tests for electronic product radiation safety, including the control of unnecessary, secondary or leakage electronic product radiation. Specifically, ***
590721 CFR 1020.30(d)(1)1Report of assembly submitted within 15 daysA completed report of assembly regarding certified components installed in a diagnostic x-ray system was not submitted to [the Director, CDRH] [the purchaser] [the State agency responsible for radiation protection] within 15 days following the completion of the assembly. Specifically, ***

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