| fei_number,inspection_id,legal_name,inspection_end_date,fiscal_year,classification,classification_code,project_area,product_type,posted_citations,city,state,state_code,country,firm_profile,citation_count,cfr_codes_cited,citation_descriptions,days_inspection_to_warning_letter,escalated_warning_letter_action_type,escalated_within_90d,escalated_within_180d,escalated_within_365d,escalated_ever |
| 1028739,721808,"Delta Air Lines, Inc.",2011-04-12,2011,No Action Indicated (NAI),NAI,Technical Assistance: Food and Cosmetics,Food/Cosmetics,No ,Atlanta,Georgia,GA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1028739,0,,,1,Warning Letter,true,true,true,true |
| 1110315,1072148,Mylan Pharmaceuticals Inc,2018-11-07,2019,No Action Indicated (NAI),NAI,Bioresearch Monitoring,Drugs,No ,Morgantown,West Virginia,WV,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1110315,0,,,2,Warning Letter,true,true,true,true |
| 1028739,718927,"Delta Air Lines, Inc.",2011-04-11,2011,No Action Indicated (NAI),NAI,Technical Assistance: Food and Cosmetics,Food/Cosmetics,No ,Atlanta,Georgia,GA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1028739,0,,,2,Warning Letter,true,true,true,true |
| 1000305334,851540,"Reser's Fine Foods, Inc.",2013-10-29,2014,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Topeka,Kansas,KS,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1000305334,10,"['21 CFR 110.10(b)(9)', '21 CFR 110.35(a)', '21 CFR 110.37(b)(4)', '21 CFR 110.20(b)(4)', '21 CFR 110.35(d)(3)', '21 CFR 110.80(b)(13)', '21 CFR 110.35(e)', '21 CFR 110.35(d)(2)', '21 CFR 110.37(b)(3)']","['Floors, walls and ceilings', As source of contamination, 'Filling, assembling, packing controls', Cleaning and sanitizing operations, Drip and condensate, 'Non-food-contact surfaces (S)', 'Storage of cleaned portable equipment (S)', Drainage, Before use and after interruption, 'Precautions against contamination--micro, foreign substances']",3,Warning Letter,true,true,true,true |
| 3005466331,852144,C.P.M. Contract Pharma GmbH & Co. KG,2013-09-27,2013,No Action Indicated (NAI),NAI,Drug Quality Assurance,Drugs,No ,Feldkirchen-Westerham,,,Germany,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3005466331,0,,,3,Warning Letter,true,true,true,true |
| 1819504,702998,"Mead Johnson & Company, LLC",2010-10-14,2011,No Action Indicated (NAI),NAI,Drug Quality Assurance,Drugs,No ,Evansville,Indiana,IN,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1819504,0,,,4,Warning Letter,true,true,true,true |
| 1417592,652020,"Medline Industries, LP",2010-03-08,2010,No Action Indicated (NAI),NAI,Compliance: Devices,Devices,No ,Northfield,Illinois,IL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1417592,0,,,4,Warning Letter,true,true,true,true |
| 3009492559,857964,"Hi-Tech Pharmaceuticals, Inc.",2013-11-08,2014,Official Action Indicated (OAI),OAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,No ,Norcross,Georgia,GA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3009492559,0,,,4,Seizure,true,true,true,true |
| 3000121413,576594,Baxalta US Inc.,2009-04-09,2009,No Action Indicated (NAI),NAI,Blood and Blood Products,Biologics,No ,Westlake Village,California,CA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3000121413,0,,,5,Warning Letter,true,true,true,true |
| 3006636678,817985,"Globe All Wellness, LLC",2013-02-08,2013,Voluntary Action Indicated (VAI),VAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,Yes,Hollywood,Florida,FL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3006636678,10,"['21 CFR 111.70(e)', '21 CFR 111.70(b)(2)', '21 CFR 111.255(a)', 21 CFR 111.453, '21 CFR 111.205(a)', 21 CFR 111.365, '21 CFR 111.95(b)(2)', '21 CFR 111.75(c)', 21 CFR 111.103, 21 CFR 111.553]","['Specifications-component purity, strength, composition', Batch record - every batch, Documentation - supplier qualification, Written procedures - product complaint, Written procedures - holding, 'Specifications - identity, purity, strength, composition', Written procedures - quality control operations, Manufacturing operations - prevent contamination, Specifications met - verify; finished batch, Master manufacturing record - each batch]",6,Seizure,true,true,true,true |
| 3006389494,615598,"Chiesi USA, Inc.",2009-04-28,2009,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,Yes,Cary,North Carolina,NC,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3006389494,3,"['21 CFR 211.110(a)', '21 CFR 211.22(d)', '21 CFR 314.81(b)(1)(ii)']","[Control procedures to monitor and validate performance, 'Procedures not in writing, fully followed', 'Contamination, chemical or physical change, deterioration']",6,Warning Letter,true,true,true,true |
| 1111062,712275,"Goetze's Candy Company, Inc.",2011-02-25,2011,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Baltimore,Maryland,MD,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1111062,4,"['21 CFR 110.10(b)(6)', '21 CFR 110.35(d)', '21 CFR 110.20(b)(4)', '21 CFR 110.10(b)(9)']","[Failure to wear, 'Floors, walls and ceilings', Failure to clean - general, 'Precautions against contamination--micro, foreign substances']",7,Warning Letter,true,true,true,true |
| 3007412977,614648,Mystical One Llc,2009-09-28,2009,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,No ,Jamaica,New York,NY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3007412977,0,,,7,Warning Letter,true,true,true,true |
| 1121886,842006,"Da'Vita Foods Company, Inc.",2013-08-09,2013,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Hagerstown,Maryland,MD,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1121886,14,"['21 CFR 110.40(b)', '21 CFR 110.10(b)(6)', '21 CFR 110.80(b)(7)', '21 CFR 110.10(b)(2)', '21 CFR 110.35(e)', '21 CFR 110.35(a)', '21 CFR 110.35(c)', '21 CFR 110.80(b)(8)', '21 CFR 110.20(b)(6)', '21 CFR 110.10(b)(8)', '21 CFR 110.35(d)', '21 CFR 110.20(a)(1)', '21 CFR 110.20(b)(2)', '21 CFR 110.37(b)(2)']","[Convey sewage, 'Storage of cleaned portable equipment (S)', Fans/air blowing equipment, Buildings/good repair, Failure to wear, Lack of effective pest exclusion, Seams on food contact surfaces, Personal food/drink/tobacco, 'Equipment, containers, utensils', Harborage areas, Failure to clean - general, 'Contamination with microorganisms, chemicals, filth, etc.', Metal / extraneous materials, Personal cleanliness]",7,Warning Letter,true,true,true,true |
| 2128643,716726,"H & P Industries, Inc.",2011-03-28,2011,Official Action Indicated (OAI),OAI,Drug Quality Assurance,Drugs,Yes,Hartland,Wisconsin,WI,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2128643,10,"['21 CFR 211.110(a)', '21 CFR 211.67(c)', 21 CFR 211.192, '21 CFR 211.160(b)', 21 CFR 211.63, '21 CFR 211.46(b)', '21 CFR 211.67(b)', 21 CFR 211.58, '21 CFR 211.48(b)', '21 CFR 211.67(b)(2)']","[Scientifically sound laboratory controls, 'Drains--Size, Back-siphonage Prevention', Cleaning SOPs/schedules, Cleaning/maintenance records not kept, 'Equipment Design, Size and Location', Written procedures not established/followed, Buildings not maintained in good state of repair, Control procedures to monitor and validate performance, 'Extent of discrepancy, failure investigations', Equipment for Environmental Control]",7,Seizure,true,true,true,true |
| 3004264479,1013529,"Professional Warehouse & Distribution, Inc.",2017-06-08,2017,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Saint Paul,Minnesota,MN,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3004264479,5,"['21 CFR 110.20(b)(1)', '21 CFR 110.35(a)', '21 CFR 110.35(c)', '21 CFR 110.20(a)(1)', '21 CFR 110.20(b)(5)']","[Lack of effective pest exclusion, Sufficient space, Harborage areas, Safety lighting and glass, Buildings/sanitary]",7,Seizure,true,true,true,true |
| 3003974891,1220175,"American Distribution and Manufacturing Co, LLC",2023-10-05,2024,No Action Indicated (NAI),NAI,Foodborne Biological Hazards,Food/Cosmetics,No ,Cottage Grove,Minnesota,MN,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3003974891,0,,,7,Warning Letter,true,true,true,true |
| 1319211,705295,"Angiodynamics, Inc.",2011-01-13,2011,Official Action Indicated (OAI),OAI,Compliance: Devices,Devices,Yes,Queensbury,New York,NY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1319211,4,"['21 CFR 803.17(a)(1)', '21 CFR 806.10(a)(1)', '21 CFR 820.198(b)', '21 CFR 820.30(c)']","[Review and evaluation for investigation, Lack of System for Event Evaluations, Design input - documentation, Report of risk to health]",8,Warning Letter,true,true,true,true |
| 3009346076,993781,"Southern Cross Tobacco Company, INC.",2016-12-01,2017,No Action Indicated (NAI),NAI,Tobacco Post-Market Activities,Tobacco,No ,Mountain Top,Pennsylvania,PA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3009346076,0,,,8,Warning Letter,true,true,true,true |
| 3004865102,554026,Do-Rene Dairy,2008-12-23,2009,Official Action Indicated (OAI),OAI,"Monitoring of Marketed Animal Drugs, Feed, and Devices",Veterinary,No ,Clovis,New Mexico,NM,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3004865102,0,,,8,Injunction,true,true,true,true |
| 3008457200,972672,Adriatic Seafood Inc,2016-06-08,2016,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Staten Island,New York,NY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3008457200,3,"['21 CFR 123.9(a)', '21 CFR 123.6(b)', '21 CFR 123.6(c)(5)']","[Records - content, Corrective action plan, HACCP plan location]",8,Warning Letter,true,true,true,true |
| 3006895770,554027,Clover Knolls Dairy,2008-12-23,2009,Official Action Indicated (OAI),OAI,"Monitoring of Marketed Animal Drugs, Feed, and Devices",Veterinary,No ,Texico,New Mexico,NM,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3006895770,0,,,8,Injunction,true,true,true,true |
| 1028739,718270,"Delta Air Lines, Inc.",2011-04-05,2011,No Action Indicated (NAI),NAI,Technical Assistance: Food and Cosmetics,Food/Cosmetics,No ,Atlanta,Georgia,GA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1028739,0,,,8,Warning Letter,true,true,true,true |
| 1028739,717871,"Delta Air Lines, Inc.",2011-04-04,2011,No Action Indicated (NAI),NAI,Technical Assistance: Food and Cosmetics,Food/Cosmetics,No ,Atlanta,Georgia,GA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1028739,0,,,9,Warning Letter,true,true,true,true |
| 3009417634,790026,"Damien Sanderlin, MD",2012-07-18,2012,Official Action Indicated (OAI),OAI,Bioresearch Monitoring,Devices,Yes,Houston,Texas,TX,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3009417634,2,[21 CFR 812.100],"[Investigator non-compliance with agreement/plan/regulations, 'No investigator protection - subject rights, safety, welfare']",9,Warning Letter,true,true,true,true |
| 3006586297,550749,Advantage Dose Llc,2008-11-12,2009,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,Yes,Shreveport,Louisiana,LA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3006586297,41,"['21 CFR 211.166(a)', '21 CFR 211.22(a)', '21 CFR 211.25(a)', '21 CFR 211.113(a)', '21 CFR 211.142(b)', '21 CFR 211.56(a)', '21 CFR 211.130(a)', '21 CFR 211.105(a)', 21 CFR 211.150, '21 CFR 211.137(a)', '21 CFR 211.125(a)', '21 CFR 211.165(a)', '21 CFR 211.56(c)', '21 CFR 211.22(c)', '21 CFR 211.165(f)', '21 CFR 211.68(a)', '21 CFR 211.94(b)', '21 CFR 211.165(b)', '21 CFR 211.80(a)', '21 CFR 211.186(a)', '21 CFR 211.115(a)', 21 CFR 211.58, '21 CFR 211.28(b)', 21 CFR 211.103, '21 CFR 211.100(a)', '21 CFR 211.67(a)', '21 CFR 211.188(b)(8)', '21 CFR 211.184(b)', '21 CFR 211.170(b)', '21 CFR 211.180(e)(2)', '21 CFR 211.188(b)(7)', '21 CFR 211.46(c)', 21 CFR 211.111, '21 CFR 211.110(a)', '21 CFR 211.198(a)', '21 CFR 211.28(a)', '21 CFR 211.166(b)']","[Actual vs. theoretical yields not determined, Written procedures followed, 'Changes to Procedures Not Reviewed, Approved', Air filtration system lacking in production area, Calibration/Inspection/Checking not done, Reserve drug product sample quantity - all tests, Annual visual exams of drug products, Procedures To Be in Writing, Component Test Records, Reprocessed drug products not meeting acceptance criteria, 'Identification of containers, lines, equipment', Microbiological testing, Strict control not exercised over labeling issued, Exhaust systems inadequate to control air contamination, Items to cover on annual reviews, Testing and release for distribution, Protective Apparel Not Worn, 'Approve or reject components, products', GMP Training Frequency, Cleaning / Sanitizing / Maintenance, Procedures for non-sterile drug products, Reprocessing procedures not written or followed, Buildings not maintained in good state of repair, Protection from external factors, 'Actual yield, % of theoretical yield', Establishment of time limitations, Control procedures to monitor and validate performance, Written procedures lacking for use of pesticides etc., Habits of good sanitation & health, 'Sanitation--buildings not clean, free of infestation', Air recirculation of dust from production areas, Reporting of adverse drug experience to FDA, Labeling control records including specimens or copies, Expiration date lacking, 'Prevention of cross contamination, mix-ups', Accelerated stability studies, Written distribution procedure, Approve or reject procedures or specs, Lack of written stability program, Storage under appropriate conditions, Approval and review of procedures]",,,false,false,false,false |
| 3005448685,565081,"Woodhaven Pharmacy Services, LLC dba Remedi SeniorCare",2009-03-19,2009,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,Yes,Baltimore,Maryland,MD,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3005448685,41,"['21 CFR 211.188(b)(11)', '21 CFR 211.188(b)(6)', '21 CFR 211.84(a)', '21 CFR 211.184(c)', 21 CFR 211.188, '21 CFR 211.42(c)', '21 CFR 211.56(b)', '21 CFR 211.46(d)', '21 CFR 211.166(a)', '21 CFR 211.22(a)', '21 CFR 211.25(a)', '21 CFR 211.67(b)', '21 CFR 211.67(a)', '21 CFR 211.188(b)(9)', 21 CFR 211.182, '21 CFR 211.180(e)(1)', '21 CFR 211.184(a)', '21 CFR 211.198(a)', '21 CFR 211.105(b)', '21 CFR 211.28(a)', '21 CFR 211.188(b)(7)', '21 CFR 211.180(e)(2)', 21 CFR 211.196, '21 CFR 211.68(a)', 21 CFR 211.192, 21 CFR 211.142, '21 CFR 211.100(a)', '21 CFR 211.170(b)', '21 CFR 211.186(a)', '21 CFR 211.80(d)', '21 CFR 211.80(a)', '21 CFR 211.42(d)', 21 CFR 211.176, '21 CFR 211.188(b)(8)', 21 CFR 211.150, '21 CFR 211.137(a)']","[Components withheld from use pending release, Items to cover on annual reviews, Adverse Drug Experience, Quality Control Review, 'Prepared for each batch, include complete information', Written procedures followed, Written procedures not established/followed, Status of Each Lot Identified, 'Training--operations, GMPs, written procedures', Individual inventory record, Penicillin processing area not kept separate, Defined areas of adequate size for operations, Lack of written stability program, Inspection of packaging and labeling area, Record information required, Procedures To Be in Writing, Approval and review of procedures, Labeling control records including specimens or copies, Expiration date lacking, Absence of Written Procedures, Identification of Persons Performing Significant Steps, Written distribution procedure, Written procedures fail to include, Cleaning / Sanitizing / Maintenance, Lack of quality control unit, Calibration/Inspection/Checking not done, Distinctive ID or code not recorded in batch record, 'Reserve samples identified, representative, stored', Written sanitation procedures lacking, 'Actual yield, % of theoretical yield', Description of containers and closures, Distribution Record Requirements, Written warehousing procedures established/followed, Penicillin air handling systems not kept separate, Quality control unit review of records, Written records kept in individual logs, Written calibration / inspection records not kept, Review of representative number of batches, Failing to test for penicillin cross-contamination, Identification of Each Lot in Each Shipment, Protective Apparel Not Worn]",,,false,false,false,false |
| 2018612,601990,"Truett Laboratories, Inc.",2009-07-06,2009,Official Action Indicated (OAI),OAI,Drug Quality Assurance,Drugs,Yes,Azusa,California,CA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2018612,40,"['21 CFR 211.68(b)', '21 CFR 211.160(b)(4)', '21 CFR 211.166(a)(3)', '21 CFR 211.165(b)', '21 CFR 211.186(b)(8)', '21 CFR 211.65(a)', '21 CFR 211.137(a)', 21 CFR 211.192, 21 CFR 211.188, '21 CFR 211.100(a)', '21 CFR 211.166(a)', '21 CFR 211.22(d)', '21 CFR 211.110(a)', '21 CFR 820.30(i)', '21 CFR 211.160(a)', '21 CFR 211.68(a)', '21 CFR 110.20(b)(2)', '21 CFR 211.160(b)', '21 CFR 211.188(b)(13)', '21 CFR 211.48(a)', 21 CFR 211.87, '21 CFR 211.125(a)', '21 CFR 211.22(b)', '21 CFR 211.125(b)', '21 CFR 211.100(b)', 21 CFR 820.40, '21 CFR 211.166(b)', '21 CFR 211.84(d)(2)', '21 CFR 211.125(c)', '21 CFR 211.188(b)(10)', '21 CFR 211.122(a)', 21 CFR 211.111, '21 CFR 211.165(e)', '21 CFR 211.130(e)', '21 CFR 211.125(f)']","[Establishment of calibration procedures, Strict control not exercised over labeling issued, 'Calibration - at intervals, written program, remedial action', 'Reports of Analysis (Components)', Expiration date lacking, Examination of issued labels, Test methods, SOPs not followed / documented, Calibration/Inspection/Checking not done, Label reconciliation discrepancies evaluation/investigation, 'Prepared for each batch, include complete information', 'Results not used for expiration dates, storage cond.', Examinations for correct labeling, Valid stability test methods, Backup file not maintained, 'Lab controls established, including changes', Packaging line inspection documentation, 'Lack of procedures, or not maintained', Equipment construction - reactive surfaces, Scientifically sound laboratory controls, Adequate lab facilities not available, Microbiological testing, Written procedures describing in detail, Procedures Written and Followed, 'Description of containers, labels, et. al.', Retest of approved components/containers/closures, Written calibration / inspection records not kept, Testing Each Component for Conformity with Specs, Establishment of time limitations, 'Procedures not in writing, fully followed', Procedure Deviations Recorded and Justified, Plumbing System Defects, Accelerated stability studies, 'Investigations of discrepancies, failures', 'Contamination with microorganisms, chemicals, filth, etc.', 'Changes to Procedures Not Reviewed, Approved', Control procedures to monitor and validate performance, Documentation of Sampling Performed, Absence of Written Procedures, Design changes - Lack of or Inadequate Procedures]",,,false,false,false,false |
| 3005984610,923718,"Nutronix Revolution, Inc.",2015-06-01,2015,Voluntary Action Indicated (VAI),VAI,Compliance: Devices,Devices,Yes,Mechanicsville,Virginia,VA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3005984610,39,"['21 CFR 211.25(b)', 21 CFR 211.188, 21 CFR 111.153, 21 CFR 111.16, '21 CFR 111.165(c)(1)', '21 CFR 111.12(c)', 21 CFR 111.453, 21 CFR 111.403, 21 CFR 111.353, '21 CFR 111.75(c)', 21 CFR 111.103, '21 CFR 820.100(a)', 21 CFR 820.50, '21 CFR 820.70(a)', 21 CFR 803.17, '21 CFR 820.20(e)', '21 CFR 111.140(b)(1)', '21 CFR 211.122(a)', '21 CFR 211.150(b)', '21 CFR 111.610(a)', 21 CFR 111.553, '21 CFR 211.166(a)', '21 CFR 211.22(d)', '21 CFR 211.165(e)', '21 CFR 111.255(d)', '21 CFR 211.198(a)', '21 CFR 111.455(a)', '21 CFR 211.25(a)', 21 CFR 111.25, '21 CFR 111.155(c)', '21 CFR 111.205(a)', '21 CFR 111.83(a)', 21 CFR 111.303, '21 CFR 820.198(a)', '21 CFR 211.100(a)', 21 CFR 111.503, '21 CFR 111.14(b)(1)', 21 CFR 111.55]","[Lack of Written MDR Procedures, 'Production, process controls - implement', Written procedures returned dietary supplement investigation, 'Purchasing controls, Lack of or inadequate procedures', 'Hold - temperature, humidity, light', Components - quarantine, 'Personnel - education, training, experience', Specifications met - verify; finished batch, Lack of or inadequate procedures, Personnel - records - written procedures, Supervisor Training/Education/Experience, Test methods, Written procedures describing in detail, Master manufacturing record - unique formulation, Complaint Handling Procedure, Written procedures - holding, Equipment - procedures, Manufacturing operations - written procedures, Lack of written stability program, 'Procedures not in writing, fully followed', Written procedures - quality control operations, Written procedures - cleaning, Records - available; FDA, Absence of Written Procedures, Quality System Procedures, Lack of or inadequate complaint procedures, Written procedures -packaging operations, Recall facilitation, 'Batch record - 1 year, 2 years', Written procedures - product complaint, Written procedures - labeling operations, 'Prepared for each batch, include complete information', 'Process control procedures, Lack of or inadequate procedures', 'Reserve sample - collect, hold', 'Training--operations, GMPs, written procedures', 'Written procedures - tests, examinations; specifications met', Product received - quarantine; representative samples, 'Written procedures - product received; packaging, labeling', Records - quality control operations; responsibilities]",,,false,false,false,false |
| 1000115118,700417,"Del Rey Tortilleria, Inc.",2011-01-27,2011,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Chicago,Illinois,IL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1000115118,37,"['21 CFR 110.80(a)(5)', '21 CFR 110.20(b)(7)', '21 CFR 110.37(a)', '21 CFR 110.37(b)(3)', '21 CFR 110.80(a)(1)', '21 CFR 110.35(c)', '21 CFR 110.10(b)(7)', '21 CFR 110.35(b)(2)', '21 CFR 110.80(b)(8)', '21 CFR 110.40(a)', '21 CFR 110.20(b)(4)', '21 CFR 110.10(b)(3)', '21 CFR 110.10(b)(8)', '21 CFR 110.37(e)(5)', '21 CFR 110.35(a)', '21 CFR 110.20(b)(5)', '21 CFR 110.40(b)', '21 CFR 110.20(a)(1)', '21 CFR 110.35(d)', 21 CFR 110.80, '21 CFR 110.80(b)(7)', '21 CFR 110.37(e)(3)', 21 CFR 110.93, '21 CFR 110.37(b)(4)', '21 CFR 110.37(b)(2)', '21 CFR 110.37(e)(2)', '21 CFR 110.80(b)(2)', n/a, '21 CFR 110.10(b)(9)', '21 CFR 110.35(d)(5)', '21 CFR 110.37(e)(1)', '21 CFR 110.37(e)']","[Drainage, Metal / extraneous materials, Storage requirements, Running water at suitable temperature, Storage, Adequate lighting, Shown to be effective, 'Storage/transportation of finished goods (contamination)', Failure to clean - general, Signs, Manufacturing conditions, Food-contact - unlawful indirect additives, Lack of effective pest exclusion, 'Floors, walls and ceilings', Cleaning and sanitizing operations, 'Equipment, containers, utensils', Procedural requirements, Testing, 'Precautions against contamination--micro, foreign substances', Drip and condensate, Buildings/good repair, Harborage areas, Food-contact - corrosion resistant, Hand cleaning and sanitizing preparations, Suitable locations, Not washed/sanitized when appropriate, Materials and workmanship, Suitable temp. and pressure, Seams on food contact surfaces, Storage of personal items, Personal food/drink/tobacco, Screening, Hand drying, Convey sewage, Safety lighting and glass, As source of contamination, Holding in bulk or suitable containers]",,,false,false,false,false |
| 1527214,538058,The Kilroy Company,2009-01-07,2009,Voluntary Action Indicated (VAI),VAI,Compliance: Devices,Devices,Yes,Mentor,Ohio,OH,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1527214,35,"['21 CFR 820.90(b)(1)', '21 CFR 820.70(a)', '21 CFR 820.20(a)', '21 CFR 820.100(a)(3)', '21 CFR 820.184(d)', '21 CFR 820.90(b)(2)', '21 CFR 820.100(b)', '21 CFR 820.72(a)', '21 CFR 820.100(a)(4)', '21 CFR 820.70(a)(2)', '21 CFR 820.100(a)(2)', '21 CFR 820.20(c)', '21 CFR 820.250(b)', '21 CFR 820.198(a)', '21 CFR 820.80(e)', '21 CFR 820.40(a)', '21 CFR 820.50(a)', '21 CFR 820.80(b)', '21 CFR 820.80(d)', '21 CFR 820.90(a)', 21 CFR 820.184, '21 CFR 820.70(b)', '21 CFR 820.75(a)', 21 CFR 820.40, '21 CFR 820.198(c)', '21 CFR 820.50(a)(2)', 21 CFR 820.20, '21 CFR 820.181(a)', '21 CFR 820.100(a)(1)', '21 CFR 820.100(a)(5)', 21 CFR 820.22]","[Quality Audits - defined intervals, 'Product rework procedures, Lack of or inadequate procedures', Statistical methodology, Management responsibility, Lack of or inadequate final acceptance procedures, Analysis of data sources, CAPA verification/validation of corrective/preventive action, Lack of or inadequate process validation, Specific non-conforming product procedures, Identification of actions needed, 'Evaluation of suppliers, contractors, etc., requirements', 'Document review, approval by designated individual', Acceptance records, Investigation of device failures, 'Production and Process Change Procedures, lack of or Inad.', Production monitoring and control, Not approved or obsolete document retrieval, Lack of or inadequate receiving acceptance procedures, Investigation, Documentation, DMR device specifications, 'Documentation of disposition, justification, signature', General, Process control procedures, Changes to correct/prevent quality problems, Lack of or inadequate DHR procedures, 'Lack of procedures, or not maintained', Quality policy and objectives, Supplier oversight, Sampling plans, Equipment suitability & capability, 'Management review - defined interval, sufficient frequency', Quality Audit/Reaudit - conducted, Analysis of data/reports from data sources]",,,false,false,false,false |
| 3005776351,556414,ITC Nexus Dx,2009-01-07,2009,Official Action Indicated (OAI),OAI,Compliance: Devices,Devices,Yes,Piscataway,New Jersey,NJ,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3005776351,35,"['21 CFR 820.250(b)', '21 CFR 803.17(a)(1)', '21 CFR 820.198(d)', '21 CFR 820.100(b)', '21 CFR 820.250(a)', '21 CFR 820.30(a)', '21 CFR 820.90(b)(1)', '21 CFR 820.30(g)', 21 CFR 820.50, '21 CFR 820.90(a)', '21 CFR 820.80(d)', '21 CFR 820.80(b)', '21 CFR 820.72(b)(1)', '21 CFR 820.40(a)', '21 CFR 820.80(d)(1)', '21 CFR 820.198(c)', '21 CFR 820.198(a)', '21 CFR 820.198(e)(5)', '21 CFR 820.20(c)', '21 CFR 820.100(a)', '21 CFR 820.198(a)(1)', 21 CFR 820.22, '21 CFR 820.72(a)', '21 CFR 820.100(a)(5)', '21 CFR 803.50(a)(1)', '21 CFR 820.100(a)(3)', '21 CFR 803.50(a)(2)', 21 CFR 820.184, '21 CFR 820.25(b)', '21 CFR 820.75(a)', '21 CFR 820.184(d)']","[Lack of or inadequate DHR procedures, General, Training - Lack of or inadequate procedures, 'DMR required activities {see also 820.181}', Individual Report of Malfunction, Lack of System for Event Evaluations, Documentation, Design Validation - Risk analysis not performed/inadequate, Investigation of device failures, Identifying corrective & preventive actions, 'Evaluation, timeliness, identification', 'Calibration, Inspection, etc. Procedures Lack of or Inadequ', 'Purchasing controls, Lack of or inadequate procedures', 'Document review, approval by designated individual', Design validation - documentation, Nature and details of complaint, Design validation - software validation not performed, 'Incoming inspection, testing, verification', Changes to correct/prevent quality problems, Calibration standard traceability, Lack of or inadequate final acceptance procedures, Management review participants, Design control - no procedures, Specific non-conforming product procedures, Lack of or inadequate process validation, Identification of actions needed, Uniform and timely processing, Report of Death or Serious Injury, Acceptance records, Sampling plans, Appropriateness, 'Procedures for product review,disposition lack of/inadequate', Lack of or inadequate receiving acceptance procedures, Quality audits - Lack of or inadequate procedures, Lack of or inadequate procedures]",,,false,false,false,false |
| 3010897424,1120120,"Lipo Naturals, LLC",2020-03-09,2020,Voluntary Action Indicated (VAI),VAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,Yes,Port St Lucie,Florida,FL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3010897424,31,"['21 CFR 111.260(e)', 21 CFR 111.123, '21 CFR 111.570(b)(1)', '21 CFR 111.260(i)', '21 CFR 111.75(a)(2)(ii)(A)', '21 CFR 111.25(c)', '21 CFR 111.430(b)', '21 CFR 111.180(b)(1)', '21 CFR 111.83(a)', '21 CFR 114.80(b)', '21 CFR 111.75(a)(1)(i)', '21 CFR 111.205(a)', '21 CFR 111.260(j)(2)', '21 CFR 114.100(b)', '21 CFR 111.260(l)(1)(ii)', '21 CFR 111.260(b)', 21 CFR 111.120, '21 CFR 111.535(b)(1)', '21 CFR 111.375(b)', '21 CFR 111.475(b)(1)', '21 CFR 111.25(b)', '21 CFR 111.260(d)', '21 CFR 111.260(c)', 21 CFR 111.103, '21 CFR 111.260(k)(2)', '21 CFR 111.260(k)', '21 CFR 111.260(l)(3)', '21 CFR 111.70(e)', 21 CFR 111.16, 21 CFR 111.403]","['Batch record - quality control; tests, examinations', 'Reserve sample - collect, hold', 'Specifications - identity, purity, strength, composition', 'Procedures - equipment - cleaning, sanitizing', Batch record - label, 'Records - packaging, labeling operations', 'Written procedures - product complaint; review, investigate', 'Quality control operations - components, packaging, labels', 'Batch record - approved, released, rejected; batch', 'Procedures - calibrating automated, mechanical equip', Component - qualify supplier, Batch record - component; unique identifier, Written procedures - quality control operations, Written procedures - cleaning, 'Batch record - component; identity, weight', Processing and production - required information, 'Written procedures - packaging, labeling received', Records - manufacturing operations; written procedures, Batch record - initials; each step, 'Written procedures - rejected components, packaging, labels', Batch record - specifications, Code - required elements, 'Records - returned dietary supplement: written procedures', Written procedures - labeling operations, Master manufacturing record - each batch, 'Component - verify identity, dietary ingredient', Written procedures - holding; distributing, 'Quality control operations - master, batch, manufacturing', 'Batch record - packaging, labeling', 'Batch record - date, time; maintenance']",,,false,false,false,false |
| 1642657,552061,"Peifon Food USA, Inc.",2008-12-08,2009,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Houston,Texas,TX,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1642657,31,"['21 CFR 110.37(e)(3)', '21 CFR 110.37(d)(3)', '21 CFR 110.20(b)(5)', '21 CFR 110.40(b)', '21 CFR 110.20(b)(7)', '21 CFR 110.10(b)(9)', '21 CFR 110.20(b)(1)', '21 CFR 110.37(a)', '21 CFR 110.20(b)(6)', '21 CFR 110.10(b)(5)', '21 CFR 110.10(b)(8)', '21 CFR 110.37(e)(5)', '21 CFR 110.10(b)(3)', '21 CFR 110.37(e)(2)', '21 CFR 110.10(b)(7)', '21 CFR 110.37(b)(3)', '21 CFR 110.35(b)(2)', '21 CFR 110.80(b)(1)', '21 CFR 110.35(c)', '21 CFR 110.10(c)', '21 CFR 110.20(a)(1)', '21 CFR 110.35(a)', 21 CFR 123.10, '21 CFR 110.40(a)', '21 CFR 110.37(d)(2)', '21 CFR 123.11(c)', '21 CFR 110.10(b)(1)', '21 CFR 110.37(e)(4)']","[Hand drying, Screening, 'Precautions against contamination--micro, foreign substances', Not washed/sanitized when appropriate, Training of handlers and supervisors, Suitable outer garments, Cleaning and sanitizing operations, Food-contact - corrosion resistant, Devices and fixtures, Sanitation Records, 'Maintenance of equip., utensils, and finished food packaging', Materials and workmanship, Storage requirements, Sufficient space, Insecticides/rodenticides, Buildings/good repair, Personal food/drink/tobacco, Seams on food contact surfaces, Storage of personal items, Good repair, Fans/air blowing equipment, Self-closing doors, HACCP training or qualification, As source of contamination, Hand cleaning and sanitizing preparations, Glove condition, Lack of effective pest exclusion, Safe and adequate sanitary quality, Harborage areas, Adequate lighting, Signs]",,,false,false,false,false |
| 3007749948,726365,Gopers Int LLC,2011-05-26,2011,Official Action Indicated (OAI),OAI,Drug Quality Assurance,Drugs,Yes,San Diego,California,CA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3007749948,31,"['21 CFR 211.84(d)(6)', '21 CFR 111.70(e)', '21 CFR 211.84(d)(2)', '21 CFR 111.570(b)(1)', '21 CFR 211.28(a)', '21 CFR 211.165(b)', '21 CFR 211.67(a)', '21 CFR 211.166(a)', '21 CFR 111.205(a)', '21 CFR 211.198(a)', '21 CFR 211.167(a)', '21 CFR 211.42(c)(1)', 21 CFR 111.65, '21 CFR 211.42(c)(10)(v)', 21 CFR 111.315, '21 CFR 211.100(a)', '21 CFR 211.42(c)(10)(i)', 21 CFR 211.188, '21 CFR 111.27(d)', '21 CFR 111.255(a)', '21 CFR 111.70(a)', '21 CFR 211.82(a)', '21 CFR 211.67(b)', 21 CFR 111.55, 21 CFR 211.63, '21 CFR 211.94(c)', '21 CFR 211.165(a)', '21 CFR 211.170(b)(1)', '21 CFR 211.42(c)(10)(vi)', '21 CFR 211.22(a)', '21 CFR 211.25(a)']","['Production, process controls - implement', Master manufacturing record - each batch, Laboratory control processes - requirements, 'Containers & Closures Clean, Sterilized, Pyrogen-free', 'Examination on receipt, before acceptance', Cleaning System, Batch record - every batch, 'Quality control - quality, dietary supplement', 'Equipment - maintain, clean, sanitize', Lack of quality control unit, Cleaning / Sanitizing / Maintenance, Absence of Written Procedures, Written procedures not established/followed, Testing and release for distribution, Microbiological Contamination Exam, Lack of written stability program, 'Written procedures - product complaint; review, investigate', Specifications - manufacturing process, Equipment to control conditions, Procedures to be written and followed, 'Floors, walls, ceiling surfaces', Protective Apparel Not Worn, 'Equipment Design, Size and Location', 'Sterility/pyrogens - test methods written, followed', Testing Each Component for Conformity with Specs, 'Specifications - identity, purity, strength, composition', Microbiological testing, 'Retention time of reserve samples, in general', 'Training , Education , Experience overall', Incoming material area, 'Prepared for each batch, include complete information']",,,false,false,false,false |
| 3001452409,1061594,"Four Elements Organic Herbals, LLC",2018-08-09,2018,Voluntary Action Indicated (VAI),VAI,Colors and Cosmetics Technology,Food/Cosmetics,Yes,North Freedom,Wisconsin,WI,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3001452409,28,"[21 CFR 11, '21 CFR 111.70(b)(3)', '21 CFR 110.37(d)(4)', '21 CFR 111.75(a)(2)(ii)(A)', '21 CFR 110.10(b)(7)', '21 CFR 110.10(c)', '21 CFR 110.80(b)(1)', 21 CFR 110.80, 21 CFR 111.353, '21 CFR 111.70(b)(1)', '21 CFR 111.535(b)(1)', '21 CFR 110.35(a)', '21 CFR 111.70(e)', 21 CFR 111.553, 21 CFR 111.303, '21 CFR 111.255(b)', '21 CFR 110.37(e)(4)', 'FDCA 601(c)', '21 CFR 111.83(a)', '21 CFR 111.160(c)', '21 CFR 111.35(b)(1)', '21 CFR 111.70(b)(2)', '21 CFR 111.205(a)', 21 CFR 111.453, '21 CFR 111.155(c)', '21 CFR 110.37(a)', 21 CFR 111.403, 21 CFR 111.65]","['Reserve sample - collect, hold', 'Specifications - identity, purity, strength, composition', Reasonable precautions, Manufacturing operations - written procedures, Batch record - complete, 'Quality control - quality, dietary supplement', Devices and fixtures, Safe and adequate sanitary quality, 'Specifications-component purity, strength, composition', Written procedures -packaging operations, 'Written procedures - equipment, utensils; make, keep', 'Packaging, labels - quarantine', Written procedures - product complaint, Doors opening into processing areas, Insanitary conditions; contaminated with filth, Specifications - component identity, Master manufacturing record - unique formulation, Written procedures - holding, Written procedures - laboratory operations, Component - qualify supplier, Specifications - contamination limits, Buildings/sanitary, Electronic records, Storage of personal items, 'Records - returned dietary supplement: written procedures', 'Maintenance of equip., utensils, and finished food packaging', Components - quarantine, Training of handlers and supervisors]",,,false,false,false,false |
| 1770154,770193,UCH-MHS,2012-03-01,2012,Voluntary Action Indicated (VAI),VAI,Blood and Blood Products,Biologics,Yes,Colorado Springs,Colorado,CO,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1770154,28,"['21 CFR 630.40(c)', '21 CFR 211.25(a)', '21 CFR 640.25(b)(4)', '21 CFR 211.22(a)', '21 CFR 606.160(e)(1)', '21 CFR 630.40(a)', '21 CFR 606.160(a)(1)', 21 CFR 640.61, '21 CFR 606.100(b)(5)', '21 CFR 640.4(h)', '21 CFR 211.160(b)', '21 CFR 640.3(a)(1)', '21 CFR 606.100(c)', '21 CFR 606.160(b)', '21 CFR 211.160(a)', '21 CFR 606.100(b)(10)', '21 CFR 606.170(a)', '21 CFR 606.100(b)', '21 CFR 606.110(a)', '21 CFR 211.22(d)', 21 CFR 211.192, '21 CFR 640.11(b)', '21 CFR 640.3(a)', '21 CFR 640.4(f)']","['Investigations of discrepancies, failures', 'Lab controls established, including changes', Arm preparation, Adverse Reaction- Reports of Investigations, GMP Training Frequency, General requirements - inspection, 'Person performing, test results, interpretation', Storage temperatures after collection, Donor suitability by means of medical history, Controlling storage temperatures, Obtaining consent in an appropriate manner, Thorough investigations, Donor suitability procedures not followed, Concurrent documentation, 'Establish, maintain and follow manufacturing SOPs', 'Procedures not in writing, fully followed', Written certification, Scientifically sound laboratory controls, Explanation of hazards, Required records, Notification, Notification w/in 8 weeks, Donor deferral record - each location, Lack of quality control unit, Supervision of qualified physician, Accurate measurement of quantity of blood, Documentation, Corrective action]",,,false,false,false,false |
| 3007120595,773305,Pennsylvania Correctional Industries,2012-03-21,2012,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,Yes,Huntingdon,Pennsylvania,PA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3007120595,28,"['21 CFR 211.170(b)(1)', '21 CFR 211.84(d)(2)', '21 CFR 211.100(a)', '21 CFR 211.150(b)', '21 CFR 211.122(a)', 21 CFR 211.182, 21 CFR 211.188, '21 CFR 211.68(a)', '21 CFR 211.165(c)', '21 CFR 211.186(a)', '21 CFR 211.165(e)', '21 CFR 211.56(c)', '21 CFR 211.80(d)', '21 CFR 211.22(a)', '21 CFR 211.25(a)', '21 CFR 211.110(a)', '21 CFR 211.180(e)(1)', '21 CFR 211.125(a)', 21 CFR 211.103, '21 CFR 211.84(a)', '21 CFR 211.80(a)', '21 CFR 211.198(a)', '21 CFR 211.67(b)', 21 CFR 211.150, 21 CFR 211.130, '21 CFR 211.25(b)', 21 CFR 211.142]","[Written warehousing procedures established/followed, Review of representative number of batches, 'Reports of Analysis (Components)', 'Retention time of reserve samples, in general', Status of Each Lot Identified, Recall facilitation, Written procedures lacking for use of pesticides etc., Calibration/Inspection/Checking not done, Lack of quality control unit, Supervisor Training/Education/Experience, GMP Training Frequency, Test methods, 'Procedures are written, and followed', Written procedures not established/followed, 'Dedicated equipment: records part of batch record', Written distribution procedure, Absence of Written Procedures, Strict control not exercised over labeling issued, Reporting of adverse drug experience to FDA, Written procedures describing in detail, Procedures To Be in Writing, Components withheld from use pending release, 'Prepared for each batch, include complete information', Written procedures followed, Actual vs. theoretical yields not determined, Quality Control Review, Control procedures to monitor and validate performance, Sampling and testing plans not described]",,,false,false,false,false |
| 1000139959,1090817,Life Rising Corporation,2019-05-17,2019,Official Action Indicated (OAI),OAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,Yes,Willowbrook,Illinois,IL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1000139959,27,"['21 CFR 111.15(k)', '21 CFR 111.205(b)(2)', '21 CFR 111.210(c)', '21 CFR 111.255(b)', '21 CFR 111.210(f)', '21 CFR 111.210(h)(5)', '21 CFR 111.260(k)(3)', '21 CFR 111.75(a)(2)(ii)(A)', '21 CFR 111.75(a)(2)(ii)(B)', '21 CFR 111.210(a)', '21 CFR 111.210(g)', '21 CFR 111.35(b)(3)', '21 CFR 111.14(b)(2)', '21 CFR 111.70(e)', '21 CFR 111.75(a)(2)(ii)(D)', '21 CFR 111.25(c)', '21 CFR 111.75(c)', 21 CFR 111.103, 21 CFR 111.16, 21 CFR 111.425, '21 CFR 111.105(i)', '21 CFR 111.113(b)(1)', '21 CFR 111.83(a)', '21 CFR 111.255(a)', '21 CFR 111.205(a)', '21 CFR 111.27(d)', 21 CFR 111.605]","[Corrective action plans, 'Master manufacturing record - components; weight, measure', 'Specifications - identity, purity, strength, composition', 'Reserve sample - collect, hold', Written procedures - pest control, Component - qualify supplier, 'Packaging description, representative label', Master manufacturing record - each batch, Personnel - records - training, Batch record - every batch, 'Records - keep: 1 year, 2 years', Equipment - maintain - general, 'Master manufacturing record - controls, procedures', Quality control - dietary supplement; adulteration, Re-confirm certificate of analysis, 'Quarantine - rejected packaged, labeled dietary supplement', Written procedures - quality control operations, Master manufacturing record - dietary ingredients, Batch record - complete, Component - certificate of analysis, Specifications met - verify; finished batch, Sanitation supervisors - assigned, 'Instruments, controls; calibrate date, reference std, method', 'Batch record - tests, examinations; results', 'Procedures - equipment - cleaning, sanitizing', Master manufacturing record theoretical and expected yield, QC required operations components packaging labels]",,,false,false,false,false |
| 3006899072,711505,"Shair Laboratories, Inc.",2011-03-22,2011,Voluntary Action Indicated (VAI),VAI,Colors and Cosmetics Technology,Food/Cosmetics,Yes,Louisville,Kentucky,KY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3006899072,27,"['21 CFR 211.25(a)', '21 CFR 211.22(a)', 21 CFR 211.103, '21 CFR 211.110(c)', '21 CFR 211.67(b)', 21 CFR 211.34, '21 CFR 211.22(d)', '21 CFR 211.165(a)', '21 CFR 211.150(b)', 21 CFR 211.52, '21 CFR 211.134(b)', '21 CFR 211.142(a)', 21 CFR 211.111, '21 CFR 211.56(c)', '21 CFR 211.198(a)', '21 CFR 211.105(b)', '21 CFR 211.137(a)', '21 CFR 211.68(a)', '21 CFR 211.170(b)(1)', '21 CFR 211.80(b)', '21 CFR 211.160(b)(4)', '21 CFR 211.125(a)', '21 CFR 211.42(c)', 21 CFR 211.188, '21 CFR 211.122(b)', '21 CFR 211.80(a)', '21 CFR 211.165(c)']","[Defined areas of adequate size for operations, In-process materials characteristics testing, Written procedures not established/followed, Testing and release for distribution, Strict control not exercised over labeling issued, Labeling and packaging improperly approved/released, Procedures To Be in Writing, Expiration date lacking, Distinctive ID or code not recorded in batch record, Washing and toilet facilities are deficient, Consultant Records, 'Retention time of reserve samples, in general', Establishment of time limitations, Calibration/Inspection/Checking not done, Quarantine - actual practice, Representative samples after completion, 'Calibration - at intervals, written program, remedial action', 'Prepared for each batch, include complete information', Actual vs. theoretical yields not determined, 'Training--operations, GMPs, written procedures', Lack of quality control unit, Handling and Storage to Prevent Contamination, 'Procedures not in writing, fully followed', Written procedures lacking for use of pesticides etc., Distribution Recall System, Complaint Handling Procedure, Sampling and testing plans not described]",,,false,false,false,false |
| 2512009,1241018,"Penn Herb Company, Ltd.",2024-06-13,2024,Official Action Indicated (OAI),OAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,Yes,Philadelphia,Pennsylvania,PA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2512009,26,"['21 CFR 111.70(b)(1)', 21 CFR 111.12, '21 CFR 111.113(a)(1)', '21 CFR 111.27(d)', '21 CFR 111.70(b)(3)', '21 CFR 111.130(a)', '21 CFR 111.83(b)(4)', '21 CFR 111.27(a)', '21 CFR 111.205(b)(1)', 21 CFR 111.360, '21 CFR 111.70(b)(2)', '21 CFR 111.27(b)', '21 CFR 111.123(a)(1)', 21 CFR 111.55, '21 CFR 111.30(b)', '21 CFR 111.12(c)', '21 CFR 111.70(e)', '21 CFR 111.205(c)', '21 CFR 111.15(b)(1)', '21 CFR 111.365(i)', '21 CFR 111.27(a)(7)', '21 CFR 111.27(d)(1)', '21 CFR 111.255(b)', '21 CFR 111.475(b)(2)', '21 CFR 111.205(a)']","[Specifications - component identity, Equipment - taken apart, Physical plant - clean and sanitary, Personnel - quality control personnel - qualified, 'Compressed air, gases', Records - product distribution, Specifications - contamination limits, 'Specifications - identity, purity, strength, composition', 'Metal, foreign material', 'Personnel - education, training, experience', 'Quality control production, process control; material review, disposition', 'Quality control operations - master manufacturing record, modifications', Master manufacturing record - specifications; quality, 'Production, process controls - implement', 'Equipment - maintain, clean, sanitize', 'Quality control returned dietary supplement; material review, disposition', 'Specifications-component purity, strength, composition', Reserve sample - twice the quantity, Master manufacturing record - each batch, Equipment - design - suitable, Manufacturing operations - sanitation, Instruments - calibration, 'Master manufacturing record: 1 year, 2 years', Batch record - complete, Equipment - automated - suitability, Specifications - contamination limits]",,,false,false,false,false |
| 2000012717,1268397,"Western Innovations, Inc.",2025-04-30,2025,Voluntary Action Indicated (VAI),VAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,Yes,Denver,Colorado,CO,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2000012717,26,"['21 CFR 111.27(b)', 21 CFR 111.303, 21 CFR 111.210, 21 CFR 111.353, '21 CFR 111.205(a)', '21 CFR 111.205(b)(1)', 21 CFR 111.103, '21 CFR 111.70(e)', '21 CFR 111.570(b)(2)(ii)', '21 CFR 111.70(b)', '21 CFR 111.75(a)(2)(ii)(A)', '21 CFR 111.105(b)', '21 CFR 111.75(a)(2)(ii)(E)', 21 CFR 111.260, '21 CFR 111.325(b)', '21 CFR 111.75(c)(1)', '21 CFR 111.415(h)', '21 CFR 111.155(e)', 21 CFR 111.403, '21 CFR 111.12(b)', '21 CFR 111.180(b)', 21 CFR 111.25, '21 CFR 111.105(a)', '21 CFR 111.27(a)', '21 CFR 111.255(b)', '21 CFR 111.27(d)(4)']","[Documentation - components, 'Obsolete labels, packaging - dispose', Personnel - quality control operations; responsibilities, Batch record - complete, Master manufacturing record - record requirements, 'Master manufacturing record - specifications, quality; packaging, labeling', 'Quality control - processes, specifications, written procedures', Make and keep records - laboratory operations, Written procedures - establish; laboratory, Equipment - establish written procedures, Instruments - calibration, Master manufacturing record - prepared, Contact surfaces - not in direct contact - cleaning, Batch record - required information, Written procedures - establish; quality control operations, Written procedures - establish; packaging & labeling, Specifications - finished dietary supplement, Component - qualify supplier, Quality control - supplier qualification, Equipment - design - appropriate and suitable, 'Specifications met - verify; production, process control', Written procedures - establish; manufacturing operations, 'Components - contamination, deterioration, mix-ups', Specifications - components, Record - product complaint; written record information, 'Documentation - quality control, review, approve supplier']",,,false,false,false,false |
| 1412287,605929,Primrose Candy Co.,2009-08-19,2009,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,Yes,Chicago,Illinois,IL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1412287,26,"['21 CFR 211.67(b)', '21 CFR 211.122(a)', '21 CFR 110.35(a)', '21 CFR 211.186(b)(9)', '21 CFR 211.166(a)', '21 CFR 211.22(d)', 21 CFR 211.192, '21 CFR 211.68(a)', 21 CFR 211.63, '21 CFR 211.198(b)(3)', '21 CFR 211.184(c)', '21 CFR 211.160(b)', '21 CFR 211.165(f)', '21 CFR 211.160(b)(3)', '21 CFR 211.110(a)', '21 CFR 211.25(a)', '21 CFR 211.22(b)', '21 CFR 211.188(b)', '21 CFR 211.84(d)(2)', '21 CFR 211.130(e)', '21 CFR 211.113(a)', '21 CFR 211.125(f)', '21 CFR 211.115(a)', '21 CFR 211.198(a)', 21 CFR 211.111]","[Lack of written stability program, Drug product sample, Sampling/testing of labeling/packaging materials, Procedures for non-sterile drug products, Buildings/sanitary, Reprocessing procedures not written or followed, Complaint Handling Procedure, No written record of investigation, Manufacturing Instructions and Specifications, Procedures Written and Followed, Packaging line inspection documentation, Control procedures to monitor and validate performance, 'Reports of Analysis (Components)', Scientifically sound laboratory controls, Batch production and Batch Control Record Requirements, Failing drug products not rejected, Adequate lab facilities not available, Individual inventory record, 'Equipment Design, Size and Location', 'Training--operations, GMPs, written procedures', Written procedures fail to include, Establishment of time limitations, Quality control unit review of records, 'Procedures not in writing, fully followed', Calibration/Inspection/Checking not done, Determination not to conduct investigation of complaint]",,,false,false,false,false |
| 3000718719,651821,"Power Line Packaging, Inc.",2010-02-08,2010,Voluntary Action Indicated (VAI),VAI,Compliance: Devices,Devices,Yes,Conshohocken,Pennsylvania,PA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3000718719,26,"['21 CFR 211.84(d)(6)', '21 CFR 211.188(b)(11)', '21 CFR 211.100(a)', '21 CFR 211.194(a)(1)', '21 CFR 820.70(c)', 21 CFR 211.63, '21 CFR 211.46(c)', '21 CFR 211.42(c)', '21 CFR 211.130(d)', '21 CFR 211.105(b)', '21 CFR 211.160(b)(2)', '21 CFR 211.160(b)(3)', '21 CFR 211.80(d)', '21 CFR 211.100(b)', '21 CFR 211.188(b)(12)', '21 CFR 211.84(d)(2)', '21 CFR 211.22(d)', '21 CFR 211.188(b)(8)', '21 CFR 211.194(a)(8)', '21 CFR 820.75(a)', '21 CFR 211.67(c)', '21 CFR 211.80(a)', '21 CFR 110.80(b)(2)', 21 CFR 211.182, 21 CFR 211.130]","[Status of Each Lot Identified, Investigations made into any unexplained discrepancy, Written records kept in individual logs, 'Procedures not in writing, fully followed', Absence of Written Procedures, Examination of packaging and labeling, 'Equipment Design, Size and Location', 'Identification of persons involved, each significant step', 'In-process samples representative, identified properly', 'Reports of Analysis (Components)', 'Drug products - samples representative, identified properly', 'Procedures are written, and followed', Personnel dating/signing equipment log, Distinctive ID or code not recorded in batch record, Manufacturing conditions, Cleaning/maintenance records not kept, Procedure Deviations Recorded and Justified, Procedures To Be in Writing, Environmental control Lack of or inadequate procedures, Sample identification and other information, Labeling control records including specimens or copies, Microbiological Contamination Exam, Second person sign off, Exhaust systems inadequate to control air contamination, Documentation, Defined areas of adequate size for operations]",,,false,false,false,false |
| 3005047545,704397,"Danny Cash Unlimited, LLC dba Branded Sauces",2011-01-03,2011,Voluntary Action Indicated (VAI),VAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,Yes,Sheridan,Colorado,CO,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3005047545,26,"['21 CFR 108.25(c)(2)', '21 CFR 114.80(b)', '21 CFR 110.80(b)(8)', '21 CFR 110.20(b)(4)', '21 CFR 110.10(b)(8)', '21 CFR 110.10(b)(3)', '21 CFR 110.37(e)(5)', '21 CFR 110.40(d)', 21 CFR 114.10, 21 CFR 114.83, '21 CFR 110.35(d)(5)', '21 CFR 110.35(e)', '21 CFR 110.20(b)(1)', '21 CFR 108.25(c)(1)', '21 CFR 110.10(b)(6)', '21 CFR 114.100(a)', '21 CFR 110.37(e)(4)', '21 CFR 110.10(c)', '21 CFR 110.80(a)(1)', 21 CFR 114.89, '21 CFR 110.35(a)', '21 CFR 114.100(b)', '21 CFR 110.37(d)(3)', '21 CFR 110.40(f)', '21 CFR 110.20(b)(7)']","[Signs, Process filing, Buildings/good repair, Self-closing doors, Screening, 'Q.C. instrument accuracy, maintenance', Not washed/sanitized when appropriate, Personnel, Effective use of hair restraint, Scheduled process establishment, 'Floors, walls and ceilings', Storage, Sufficient space, Process deviation evaluation - record, Devices and fixtures, Maintenance of processing and production records, 'Holding, conveying, mfg systems - design & construction', Metal / extraneous materials, Cleaning and sanitizing operations, Personal food/drink/tobacco, Code - required elements, Registration, Shown to be effective, 'Storage of cleaned portable equipment (S)', 'Raw materials, packaging, finished product', 'Level of competency (S)']",,,false,false,false,false |
| 1517875,967057,Frank L Harter & Sons Inc,2016-03-28,2016,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Cincinnati,Ohio,OH,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1517875,26,"['21 CFR 123.6(c)(4)', '21 CFR 110.80(b)(2)', '21 CFR 110.37(e)(3)', '21 CFR 123.6(c)(5)', '21 CFR 123.6(c)(1)', '21 CFR 110.35(a)', '21 CFR 123.6(b)', '21 CFR 123.11(c)', '21 CFR 110.20(b)(6)', '21 CFR 123.6(c)(7)', '21 CFR 110.10(b)(4)', '21 CFR 110.10(b)(1)', '21 CFR 110.37(b)(5)', '21 CFR 110.10(c)', '21 CFR 110.80(a)(1)', '21 CFR 110.35(c)', '21 CFR 110.10(b)(8)', '21 CFR 123.6(d)', '21 CFR 110.20(b)(7)', '21 CFR 123.6(c)(2)', '21 CFR 123.9(a)', '21 CFR 110.40(a)', '21 CFR 123.6(c)(6)', '21 CFR 110.10(a)', '21 CFR 123.6(a)']","[Personal food/drink/tobacco, Monitoring - adequacy, Materials and workmanship, Storage, Screening, Hazard analysis, HACCP plan implementation, Critical control points, No HACCP plan, 'Employees with illness, lesions, contamination source', Insecticides/rodenticides, Hand jewelry - remove/cover, Manufacturing conditions, Records - content, Hand drying, Verification procedures - adequacy, Training of handlers and supervisors, Food safety hazards, Records system, Buildings/sanitary, Cross contamination, Fans/air blowing equipment, Suitable outer garments, Sanitation Records, Corrective action plan, Signed and dated]",,,false,false,false,false |
| 3003818194,547903,"AFAM Concept, Inc.",2008-12-11,2009,Voluntary Action Indicated (VAI),VAI,Colors and Cosmetics Technology,Food/Cosmetics,Yes,Chicago,Illinois,IL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3003818194,25,"['21 CFR 211.166(a)', '21 CFR 211.22(d)', 21 CFR 211.192, '21 CFR 211.188(b)', '21 CFR 211.67(b)', 21 CFR 211.103, '21 CFR 211.80(a)', '21 CFR 211.184(c)', '21 CFR 211.22(b)', '21 CFR 211.160(b)(4)', '21 CFR 211.84(d)(1)', '21 CFR 211.122(c)', '21 CFR 211.122(a)', '21 CFR 211.150(b)', '21 CFR 211.101(d)', '21 CFR 211.160(b)', '21 CFR 211.198(a)', '21 CFR 211.130(e)', '21 CFR 211.186(a)', '21 CFR 211.100(a)', '21 CFR 211.25(a)']","[Approval and review of procedures, Quality control unit review of records, 'Procedures not in writing, fully followed', Establishment of calibration procedures, Identity Testing of Each Component, Individual inventory record, No written record of investigation, Complaint Handling Procedure, Procedures To Be in Writing, Written calibration procedures, Adequate lab facilities not available, Distribution Recall System, Packaging line inspection after use, 'Training--operations, GMPs, written procedures', Component addition checked by 2nd person, Scientifically sound laboratory controls, Batch production and Batch Control Record Requirements, Records fail to include, Lack of written stability program, Written procedures fail to include, Written procedures describing in detail, Absence of Written Procedures, Actual vs. theoretical yields not determined, Written procedures followed, Packaging line inspection before use]",,,false,false,false,false |
| 3012470152,619856,PASSAFIUME AJ & SONS INC,2009-09-17,2009,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Louisville,Kentucky,KY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3012470152,25,"['21 CFR 110.20(b)(7)', '21 CFR 110.35(d)(3)', '21 CFR 110.10(b)(7)', '21 CFR 110.37(b)(5)', '21 CFR 110.10(c)', '21 CFR 110.35(c)', '21 CFR 110.80(a)(1)', '21 CFR 110.20(b)(5)', '21 CFR 110.35(d)(4)', '21 CFR 110.35(a)', '21 CFR 110.37(e)(5)', '21 CFR 110.10(b)(8)', '21 CFR 110.10(b)(3)', '21 CFR 110.20(b)(6)', '21 CFR 110.20(b)(4)', '21 CFR 110.35(d)(5)', '21 CFR 110.35(b)(2)', '21 CFR 110.40(c)', '21 CFR 110.37(e)(3)', '21 CFR 110.20(a)(1)', '21 CFR 110.35(e)', '21 CFR 110.20(b)(1)', '21 CFR 110.37(f)']","[Drip and condensate, Harborage areas, 'Odor, attractant for pests, harborage', 'Storage of cleaned portable equipment (S)', Storage requirements, Backflow prevention, Hand drying, 'Level of competency (S)', Screening, Storage, Lack of effective pest exclusion, Single-service articles, Non food-contact equipment in processing area, Signs, Buildings/sanitary, 'Non-food-contact surfaces (S)', Fans/air blowing equipment, Personal food/drink/tobacco, Storage of personal items, 'Floors, walls and ceilings', Not washed/sanitized when appropriate, Safety lighting and glass, Training of handlers and supervisors, Safe and adequate for use, Sufficient space]",,,false,false,false,false |
| 3002990412,710788,"JSP Enterprises, LTD",2011-02-11,2011,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Denver,Colorado,CO,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3002990412,25,"['21 CFR 110.10(b)(1)', '21 CFR 110.35(a)', '21 CFR 110.10(b)(6)', '21 CFR 110.35(d)(5)', '21 CFR 123.8(a)(3)', '21 CFR 110.80(b)(5)', '21 CFR 110.40(f)', '21 CFR 110.20(b)(6)', '21 CFR 123.8(a)(3)(i)', '21 CFR 123.6(c)(3)', '21 CFR 123.6(c)(4)', '21 CFR 110.10(b)(5)', '21 CFR 123.8(a)(2)(ii)', '21 CFR 110.80(b)(7)', '21 CFR 123.11(a)', '21 CFR 123.6(b)', '21 CFR 123.9(a)', '21 CFR 110.35(d)', '21 CFR 110.80(b)(2)', '21 CFR 123.11(b)', '21 CFR 110.37(e)(5)', '21 CFR 110.10(b)(8)', '21 CFR 110.10(b)(3)', '21 CFR 110.40(a)']","['Installation and maintenance of equipment (S)', Calibration - adequacy, Personal food/drink/tobacco, Cleaning and sanitizing operations, Critical limits, 'SSOP(S)', Signs, Failure to clean - general, Records - content, Sanitation monitoring, No HACCP plan, Safe and adequate for use, Verification - record review - frequency, Failure to wear, Glove condition, Fans/air blowing equipment, Suitable outer garments, Manufacturing conditions, 'Equipment, containers, utensils', Not washed/sanitized when appropriate, 'Q.C. instrument accuracy, maintenance', Monitoring record review adequacy, HACCP plan implementation, Work-in-progress, Monitoring - adequacy]",,,false,false,false,false |
| 3003277665,711952,Campango Limited dba Hinman Pie,2011-02-25,2011,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Denver,Colorado,CO,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3003277665,25,"['21 CFR 110.10(b)(6)', '21 CFR 110.35(d)(5)', '21 CFR 110.37(e)(4)', '21 CFR 110.20(b)(4)', '21 CFR 110.35(d)', '21 CFR 110.80(a)(1)', '21 CFR 110.10(c)', '21 CFR 110.37(e)(5)', '21 CFR 110.10(b)(8)', '21 CFR 110.10(b)(3)', '21 CFR 110.37(b)(2)', '21 CFR 110.80(b)(2)', '21 CFR 110.40(c)', '21 CFR 110.40(d)', '21 CFR 110.80(a)(5)', '21 CFR 110.80(b)(7)', '21 CFR 110.10(b)(2)', '21 CFR 110.40(a)', '21 CFR 110.20(b)(7)', '21 CFR 110.80(b)(8)', '21 CFR 110.20(b)(5)', '21 CFR 110.10(b)(4)']","[Food contact - non-toxic materials, Effective use of hair restraint, Safe and adequate for use, Manufacturing conditions, Food-contact - corrosion resistant, 'Equipment, containers, utensils', Training of handlers and supervisors, Personal cleanliness, Materials and workmanship, Personal food/drink/tobacco, Failure to clean - general, Unsecured jewelry, Signs, Non food-contact equipment in processing area, 'Holding, conveying, mfg systems - design & construction', Food-contact - withstand food & cleaning cmpds., Screening, Not washed/sanitized when appropriate, Spacing of equipment, Convey sewage, Holding in bulk or suitable containers, Safety lighting and glass, Storage, Devices and fixtures, Metal / extraneous materials]",,,false,false,false,false |
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