| 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 |
| 2016528,1020790,"Cerreta Candy Company, Inc.",2017-08-08,2017,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Glendale,Arizona,AZ,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2016528,10,"['21 CFR 110.10(b)(6)', '21 CFR 110.35(b)(1)', '21 CFR 110.35(a)', '21 CFR 110.40(a)', '21 CFR 110.80(b)(8)', '21 CFR 110.20(b)(1)', '21 CFR 110.35(c)', 21 CFR 110.80, '21 CFR 110.20(a)(1)', '21 CFR 110.20(b)(5)']","[Safety lighting and glass, Sufficient space, Buildings/sanitary, Failure to wear, Metal / extraneous materials, Materials and workmanship, Safe and adequate for use, Harborage areas, Reasonable precautions, Lack of effective pest exclusion]",36,Warning Letter,true,true,true,true |
| 3005352998,1001780,SI Marketing Inc.,2017-02-13,2017,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Honolulu,Hawaii,HI,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3005352998,6,"['21 CFR 123.6(c)(1)', 21 CFR 123.10, '21 CFR 123.6(b)', '21 CFR 123.11(b)', '21 CFR 123.6(c)(5)', '21 CFR 123.11(c)']","[Food safety hazards, Sanitation Records, HACCP training or qualification, HACCP plan implementation, Corrective action plan, Sanitation monitoring]",50,Warning Letter,true,true,true,true |
| 3010514,759850,Tree Top Inc,2011-12-09,2012,No Action Indicated (NAI),NAI,Foodborne Biological Hazards,Food/Cosmetics,No ,Selah,Washington,WA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3010514,0,,,61,Warning Letter,true,true,true,true |
| 3003808759,1093948,"Sugarcreek Livestock Auction, Inc.",2019-06-24,2019,Official Action Indicated (OAI),OAI,"Monitoring of Marketed Animal Drugs, Feed, and Devices",Veterinary,Yes,Sugarcreek,Ohio,OH,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3003808759,6,"['FDCA 402(a)(4)', '21 CFR 530.11(d)', 'FDCA 501(a)(5)']","[Expired drugs administered, 'Use of veterinary prescription drug(s) without a prescription', Control of treated animals, Record keeping, System for administration of drugs, ELDU - producer causes Illegal drug residue]",74,Warning Letter,true,true,true,true |
| 3007791573,872124,MANI HANOI CO. LTD,2014-03-20,2014,Official Action Indicated (OAI),OAI,Compliance: Devices,Devices,Yes,Pho Yen Town,,,Vietnam,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3007791573,6,"['21 CFR 820.100(b)', '21 CFR 820.75(a)', '21 CFR 820.70(c)', 21 CFR 820.40, '21 CFR 820.100(a)', 21 CFR 820.184]","[Documentation, DHR - not or inadequately maintained, Lack of or inadequate procedures, Environmental control Lack of or inadequate procedures, Procedures not adequately established or maintained, Lack of or inadequate process validation]",83,Warning Letter,true,true,true,true |
| 3005632830,969550,Phillip Thompson,2016-05-11,2016,No Action Indicated (NAI),NAI,"Monitoring of Marketed Animal Drugs, Feed, and Devices",Veterinary,Yes,Union Bridge,Maryland,MD,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3005632830,7,"['21 CFR 530.11(a)', '21 CFR 530.11(d)', 'FDCA 402(a)(4)', '21 CFR 530.41(a)']","['Drugs prohibited for extralabel use in food-producing animal(s)', Route of administration, ELDU - producer causes Illegal drug residue, 'Drug inventory (control of drugs on premises)', Withdrawal period, Record keeping, 'Individual identity of animal(s)']",91,Warning Letter,false,true,true,true |
| 1000560772,699614,BioSculptor Corporation,2010-11-30,2011,Official Action Indicated (OAI),OAI,Compliance: Devices,Devices,Yes,Hialeah,Florida,FL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1000560772,10,"[21 CFR 803.17, '21 CFR 820.20(c)', 21 CFR 820.22, '21 CFR 820.198(e)', '21 CFR 820.30(a)', '21 CFR 820.30(g)', 21 CFR 1002.13, '21 CFR 820.70(b)', '21 CFR 820.100(a)', '21 CFR 820.50(a)(3)']","[Management review - Lack of or inadequate procedures, Failure to submit, Quality audits - Lack of or inadequate procedures, 'Production and Process Change Procedures, lack of or Inad.', 'Acceptable supplier records, inadequate records', Design control - no procedures, Lack of or inadequate procedures, Design validation - Risk analysis, Maintained, Lack of Written MDR Procedures]",99,Warning Letter,false,true,true,true |
| 1000125474,1182095,"Mariscos Bahia, Inc.",2022-10-21,2023,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Pico Rivera,California,CA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1000125474,5,"['21 CFR 123.6(c)(4)', '21 CFR 123.6(c)(1)', '21 CFR 117.80(c)', '21 CFR 123.6(c)(5)', '21 CFR 123.11(b)']","['Manufacturing, processing, packing, holding - Controls', Sanitation monitoring, Monitoring - adequacy, Corrective action plan, Food safety hazards]",109,Warning Letter,false,true,true,true |
| 1623891,583143,Olam Chile Peppers LLC,2009-05-15,2009,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Deming,New Mexico,NM,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1623891,26,"['21 CFR 114.80(a)(1)', '21 CFR 114.80(b)', '21 CFR 110.37(e)', '21 CFR 110.20(b)(4)', '21 CFR 110.37(e)(1)', '21 CFR 110.20(b)(6)', '21 CFR 110.80(b)(15)', '21 CFR 110.40(a)', '21 CFR 114.80(a)(4)', '21 CFR 110.40(f)', '21 CFR 110.20(b)(7)', '21 CFR 110.37(d)(2)', '21 CFR 110.35(a)', '21 CFR 110.40(b)', '21 CFR 110.20(b)(5)', 21 CFR 114.83, '21 CFR 110.80(b)(7)', 21 CFR 110.80, '21 CFR 110.37(b)(5)', '21 CFR 110.35(c)', '21 CFR 114.100(a)', '21 CFR 110.37(b)(3)', '21 CFR 110.20(a)(3)']","[Good repair, 'Raw materials, packaging, finished product', Lack of effective pest exclusion, Proper pH controls, Scheduled process establishment, Precluding contaminants, Reasonable precautions, Buildings/sanitary, 'Q.C. instrument accuracy, maintenance', Code - required elements, Seams on food contact surfaces, Drainage, Suitable locations, Fans/air blowing equipment, Thermal processing, 'Equipment, containers, utensils', Scheduled process, Cleaning and sanitizing operations, Drip and condensate, Materials and workmanship, Running water at suitable temperature, Backflow prevention, Screening, Container testing, As source of contamination, Safety lighting and glass]",117,Warning Letter,false,true,true,true |
| 3008953827,756534,K-Brand Farms,2011-12-02,2012,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Woodridge,New York,NY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3008953827,7,"['21 CFR 118.4(c)(3)', '21 CFR 118.10(a)(3)(i)', '21 CFR 118.10(b)(2)', '21 CFR 118.10(b)(1)', '21 CFR 118.4(b)(4)', '21 CFR 118.4(b)(3)', '21 CFR 118.10(a)(3)(iv)']","[Biosecurity measures documentation, Refrigeration requirements documentation, Name and location, Removal of pest harborages, Date and time of activity, Stray animals, Cross contamination from people]",123,Warning Letter,false,true,true,true |
| 2020601,892318,"MicroAire Surgical Instruments, LLC",2014-08-22,2014,Official Action Indicated (OAI),OAI,Compliance: Devices,Devices,Yes,Charlottesville,Virginia,VA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2020601,9,"['21 CFR 803.50(a)(2)', '21 CFR 820.75(a)', '21 CFR 820.70(i)', '21 CFR 820.80(c)', '21 CFR 820.70(a)', 21 CFR 820.50, '21 CFR 820.198(c)', '21 CFR 820.30(e)', '21 CFR 820.100(a)']","[Design review - Lack of or inadequate procedures, Software validation for automated processes, Lack of or inadequate procedures, Lack of or inadequate In-process acceptance procedures, 'Process control procedures, Lack of or inadequate procedures', Lack of or inadequate process validation, 'Purchasing controls, Lack of or inadequate procedures', Investigation of device failures, Individual Report of Malfunction]",129,Warning Letter,false,true,true,true |
| 2521528,574094,Ninth St. Management Inc. (Trades as Superior Pasta Co Inc.),2009-03-30,2009,Official Action Indicated (OAI),OAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,No ,Philadelphia,Pennsylvania,PA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2521528,0,,,136,Warning Letter,false,true,true,true |
| 3006315109,740084,"Spinalight, Inc.",2011-08-18,2011,Official Action Indicated (OAI),OAI,Compliance: Devices,Devices,Yes,Saint Petersburg,Florida,FL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3006315109,5,"[21 CFR 803.17, '21 CFR 820.30(a)', 21 CFR 820.22, '21 CFR 820.100(a)', 21 CFR 820.50]","[Design control - no procedures, Lack of Written MDR Procedures, 'Purchasing controls, Lack of or inadequate procedures', Lack of or inadequate procedures, Quality audits - Lack of or inadequate procedures]",144,Warning Letter,false,true,true,true |
| 1000208724,654857,"Absolute Natural Blenders, Inc.",2010-04-09,2010,Official Action Indicated (OAI),OAI,Drug Quality Assurance,Drugs,Yes,Melbourne,Florida,FL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1000208724,26,"['21 CFR 211.180(e)', '21 CFR 211.188(b)(7)', '21 CFR 211.22(d)', '21 CFR 211.166(a)', '21 CFR 211.125(a)', '21 CFR 211.160(a)', '21 CFR 211.84(d)(1)', '21 CFR 211.56(c)', '21 CFR 211.25(a)', '21 CFR 211.22(a)', '21 CFR 211.165(d)', '21 CFR 211.28(b)', '21 CFR 211.198(a)', '21 CFR 211.105(b)', '21 CFR 211.68(b)', '21 CFR 211.67(b)', '21 CFR 211.67(a)', '21 CFR 211.194(a)(5)', '21 CFR 211.160(b)(4)', '21 CFR 211.165(c)', 21 CFR 211.87, '21 CFR 211.194(a)(8)', '21 CFR 211.165(e)', '21 CFR 211.170(b)', '21 CFR 211.100(a)']","[Test methods, Distinctive ID or code not recorded in batch record, 'Lab controls established, including changes', Cleaning / Sanitizing / Maintenance, Written procedures fail to include, Habits of good sanitation & health, Records reviewed annually, Testing Calculations, Deviations from laboratory control requirements, Acceptance criteria for sampling & testing, Retest of approved components/containers/closures, 'Training--operations, GMPs, written procedures', Lack of written stability program, Contract drug products--lack of responsibility, Annual visual exams of drug products, 'Actual yield, % of theoretical yield', Adverse Drug Experience, Strict control not exercised over labeling issued, Absence of Written Procedures, Sampling and testing plans not described, 'Procedures not in writing, fully followed', 'Instruments, apparatus, et. al. not meeting specs', input/output verification, Second person sign off, Written procedures lacking for use of pesticides etc., Identity Testing of Each Component]",153,Warning Letter,false,true,true,true |
| 3001587133,1165577,American Cleaning Solutions,2022-03-28,2022,Official Action Indicated (OAI),OAI,Drug Quality Assurance,Drugs,Yes,Long Island City,New York,NY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3001587133,18,"['21 CFR 211.100(b)', '21 CFR 211.160(b)', 21 CFR 211.63, '21 CFR 211.180(b)', 21 CFR 211.130, '21 CFR 211.84(d)(2)', '21 CFR 211.160(b)(4)', '21 CFR 211.100(a)', '21 CFR 211.56(b)', 21 CFR 211.182, '21 CFR 211.198(a)', '21 CFR 211.165(f)', '21 CFR 211.25(a)', '21 CFR 211.194(a)(8)', '21 CFR 211.180(e)(2)', 21 CFR 211.58, 21 CFR 211.188, '21 CFR 211.165(a)']","[Component identification test, 'Training--operations, GMPs, written procedures', 'Procedures are written, and followed', Testing and release for distribution, Items to cover on annual reviews, 'Prepared for each batch, include complete information', Absence of Written Procedures, Test devices not meeting specifications, 'Equipment Design, Size and Location', Buildings not maintained in good state of repair, Complaint Handling Procedure, Procedure Deviations Recorded and Justified, Failing drug products not rejected, Written sanitation procedures lacking, Scientifically sound laboratory controls, Specific information required in individual logs, Second person sign off, 'Record maintenance 1 year (except exempt OTC)']",162,Warning Letter,false,true,true,true |
| 3000210122,635177,Baxter Healthcare Renal Div,2009-12-14,2010,Official Action Indicated (OAI),OAI,Compliance: Devices,Devices,Yes,Waukegan,Illinois,IL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3000210122,8,"['21 CFR 803.50(a)(2)', '21 CFR 820.100(a)(3)', '21 CFR 820.30(f)', '21 CFR 820.198(e)(7)', '21 CFR 820.198(a)', '21 CFR 820.198(a)(1)', '21 CFR 820.50(a)', '21 CFR 803.50(a)(1)']","[Uniform and timely processing, Complete files maintained, Design verification - unresolved discrepancies, 'Evaluation of suppliers, contractors, etc., requirements', Identification of actions needed, Corrective action taken, Individual Report of Malfunction, Report of Death or Serious Injury]",171,Warning Letter,false,true,true,true |
| 3003064146,670603,Rite-dent Manufacturing Corp.,2010-07-08,2010,Official Action Indicated (OAI),OAI,Compliance: Devices,Devices,Yes,Hialeah,Florida,FL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3003064146,23,"[21 CFR 820.120, '21 CFR 820.25(a)', '21 CFR 820.25(b)', 21 CFR 820.22, 21 CFR 820.40, '21 CFR 820.20(b)', '21 CFR 806.10(a)(1)', '21 CFR 820.72(a)', '21 CFR 820.100(a)', '21 CFR 820.30(g)', '21 CFR 820.70(a)', 21 CFR 820.50, '21 CFR 820.250(b)', '21 CFR 820.80(c)', 21 CFR 820.184, '21 CFR 820.20(d)', '21 CFR 820.30(a)', '21 CFR 820.20(a)', '21 CFR 820.30(f)', '21 CFR 820.80(e)']","[Design validation acceptance criteria, Design control - no procedures, Design Validation - Risk analysis not performed/inadequate, Documentation, Lack of or inadequate organizational structure, 'Purchasing controls, Lack of or inadequate procedures', Lack of or inadequate procedures, Design verification - documentation, Training - Lack of or inadequate procedures, Lack of or inadequate procedures for labeling, Personnel, Report of risk to health, DHR content, Training records, 'Lack of procedures, or not maintained', Lack of or inadequate DHR procedures, 'Process control procedures, Lack of or inadequate procedures', Equipment control activity documentation, Quality audits - Lack of or inadequate procedures, Management ensuring quality policy is understood, Quality plan, Sampling plans]",181,Seizure,false,false,true,true |
| 3008872045,884702,"Craftmatic Industries, Inc.",2014-08-08,2014,Official Action Indicated (OAI),OAI,Compliance: Devices,Devices,Yes,Pompano Beach,Florida,FL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3008872045,7,"[21 CFR 803.17, '21 CFR 820.198(a)', '21 CFR 820.30(i)', 21 CFR 820.22, '21 CFR 803.50(a)(1)', '21 CFR 820.100(a)', 21 CFR 820.50]","[Lack of Written MDR Procedures, Lack of or inadequate complaint procedures, 'Purchasing controls, Lack of or inadequate procedures', Report of Death or Serious Injury, Lack of or inadequate procedures, Quality audits - Lack of or inadequate procedures, Design changes - Lack of or Inadequate Procedures]",193,Warning Letter,false,false,true,true |
| 2022073,664709,"McGuff Pharmaceuticals, Inc.",2010-06-02,2010,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,No ,Santa Ana,California,CA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2022073,0,,,209,Warning Letter,false,false,true,true |
| 3010533670,860648,Vernon W. Zimmerman,2013-12-20,2014,Official Action Indicated (OAI),OAI,"Monitoring of Marketed Animal Drugs, Feed, and Devices",Veterinary,Yes,East Earl,Pennsylvania,PA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3010533670,6,"['21 CFR 530.11(a)', 'FDCA 402(a)(4)', '21 CFR 530.11(d)', '21 CFR 530.41(a)']","['Individual identity of animal(s)', 'Drugs prohibited for extralabel use in food-producing animal(s)', Record keeping, System for administration of drugs, ELDU - producer causes Illegal drug residue, Species or class]",229,Warning Letter,false,false,true,true |
| 1461414,927518,"Global Marketing Enterprises, Inc.",2015-07-08,2015,Official Action Indicated (OAI),OAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,Yes,Chicago,Illinois,IL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1461414,8,"['21 CFR 123.12(a)(2)', '21 CFR 111.27(d)', '21 CFR 123.11(c)', '21 CFR 111.70(a)', '21 CFR 123.6(b)', '21 CFR 111.75(a)(1)(i)', 21 CFR 111.103, '21 CFR 111.205(a)']","['Component - verify identity, dietary ingredient', Written procedures - quality control operations, Sanitation Records, 'Equipment - maintain, clean, sanitize', Importer verification, Master manufacturing record - unique formulation, No HACCP plan, Specifications - manufacturing process]",251,Warning Letter,false,false,true,true |
| 3015558893,1140984,"All Good Foods, Inc.",2021-04-30,2021,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,City Of Industry,California,CA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3015558893,1,['21 CFR 1.502(a)'],[Develop FSVP],284,Warning Letter,false,false,true,true |
| 3004843655,1106964,Essential Pharmaceutical Corp,2019-10-17,2020,Official Action Indicated (OAI),OAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,Yes,Pomona,California,CA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3004843655,12,"['21 CFR 111.35(b)(2)', '21 CFR 111.123(a)(5)', '21 CFR 111.205(b)(1)', '21 CFR 111.70(b)(2)', '21 CFR 111.255(b)', 21 CFR 111.105, '21 CFR 111.70(d)', '21 CFR 111.105(a)', '21 CFR 111.113(b)(2)', '21 CFR 111.70(b)(1)', '21 CFR 111.27(d)', '21 CFR 111.70(e)']","['Specifications-component purity, strength, composition', 'Specifications - identity, purity, strength, composition', 'Quality control - packaged, labeled', Batch record - complete, 'Specifications - labels, packaging', 'Document-equipment date of use, maintain, clean, sanitize', 'Quality control - processes, specifications, written procedures', Quality control operations - reprocessing, Master manufacturing record - specifications; quality, Quality control - reject; specification not met, Specifications - component identity, Equipment - maintain - general]",322,Warning Letter,false,false,true,true |
| 3005694111,929021,Megafine Pharma (P) Limited,2015-05-15,2015,Official Action Indicated (OAI),OAI,Drug Quality Assurance,Drugs,No ,Nashik,,,India,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3005694111,0,,,370,Warning Letter,false,false,false,true |
| 3001236660,911489,"Chinatown Wholesale, LLC",2015-01-29,2015,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,West Valley City,Utah,UT,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3001236660,10,"['21 CFR 110.20(b)(7)', '21 CFR 110.35(c)', '21 CFR 110.20(a)(1)', '21 CFR 123.11(c)', '21 CFR 110.20(b)(5)', '21 CFR 123.6(a)', '21 CFR 110.35(a)', '21 CFR 110.37(e)(5)']","[Screening, Hazard analysis, Sanitation Records, Lack of effective pest exclusion, Harborage areas, Signs, Buildings/sanitary, Buildings/good repair, Safety lighting and glass, Insecticides/rodenticides]",421,Warning Letter,false,false,false,true |
| 3003751705,638401,"Dani Jacq, Inc.",2010-01-05,2010,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,No ,Baltimore,Maryland,MD,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3003751705,0,,,482,Warning Letter,false,false,false,true |
| 1219457,720546,Greencore USA Inc.,2011-04-13,2011,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Newburyport,Massachusetts,MA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1219457,4,"['21 CFR 123.6(b)', '21 CFR 110.80(a)(1)', '21 CFR 110.80(b)(5)', '21 CFR 110.35(d)(5)']","[Work-in-progress, HACCP plan implementation, 'Water quality -- wash, rinse, convey food', Shown to be effective]",553,Warning Letter,false,false,false,true |
| 3009326765,960751,First Choice E Trading Corp.,2016-03-02,2016,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Englewood Cliffs,New Jersey,NJ,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3009326765,1,['21 CFR 123.12(a)(2)'],[Importer verification],630,Warning Letter,false,false,false,true |
| 3004086192,927397,USV Private Limited,2015-03-27,2015,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,No ,"Dabhel, Daman",,,India,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3004086192,0,,,714,Warning Letter,false,false,false,true |
| 2120699,575310,"Wild Foods, Inc",2009-04-09,2009,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Milwaukee,Wisconsin,WI,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2120699,3,"['21 CFR 110.80(b)(1)', '21 CFR 110.35(a)', '21 CFR 110.40(d)']","['Holding, conveying, mfg systems - design & construction', Buildings/sanitary, 'Maintenance of equip., utensils, and finished food packaging']",799,Warning Letter,false,false,false,true |
| 3004380716,638942,Seco Spice Ltd. Company LLC,2009-12-17,2010,Official Action Indicated (OAI),OAI,Foodborne Biological Hazards,Food/Cosmetics,No ,Anthony,New Mexico,NM,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3004380716,0,,,883,Warning Letter,false,false,false,true |
| 2434633,562938,Beyer Lightning Fish Co Inc,2009-02-11,2009,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Bronx,New York,NY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2434633,6,"['21 CFR 123.6(c)(3)', '21 CFR 123.6(c)(4)', '21 CFR 123.6(c)(5)', '21 CFR 123.6(b)', '21 CFR 123.12(a)(2)', '21 CFR 123.8(a)(2)']","[Importer verification, Monitoring - adequacy, Corrective action plan, Critical limits, 'Ongoing verification - complaints, calibration records', HACCP plan implementation]",981,Warning Letter,false,false,false,true |
| 3002807471,945390,Leventon S. A. U.,2015-09-24,2015,Voluntary Action Indicated (VAI),VAI,Compliance: Devices,Devices,No ,Sant Esteve Sesrovires,,,Spain,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3002807471,0,,,1077,Warning Letter,false,false,false,true |
| 2129133,667306,Hyline Orchard Farm Market,2010-06-16,2010,No Action Indicated (NAI),NAI,Foodborne Biological Hazards,Food/Cosmetics,No ,Fish Creek,Wisconsin,WI,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2129133,0,,,1178,Warning Letter,false,false,false,true |
| 2021236,857657,"B. Braun US Pharmaceutical Manufacturing, LLC",2013-11-13,2014,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,No ,Irvine,California,CA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2021236,0,,,1276,Warning Letter,false,false,false,true |
| 3012470814,1174236,ISA Produce Corporation,2022-07-12,2022,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Mission,Texas,TX,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3012470814,1,['21 CFR 1.502(a)'],[Develop FSVP],1379,Warning Letter,false,false,false,true |
| 2411192,1040815,"Professional Disposables International, Inc.",2017-12-01,2018,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,Yes,Orangeburg,New York,NY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=2411192,2,"['21 CFR 314.81(b)(1)(ii)', '21 CFR 211.110(a)']","[Control procedures to monitor and validate performance, Failure to meet specifications]",1498,Warning Letter,false,false,false,true |
| 1642813,742145,Chemolee Lab Corporation,2011-09-01,2011,Official Action Indicated (OAI),OAI,Drug Quality Assurance,Drugs,Yes,Irving,Texas,TX,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1642813,12,"['21 CFR 211.165(e)', '21 CFR 211.67(b)', '21 CFR 211.110(c)', '21 CFR 211.188(b)(12)', '21 CFR 211.100(b)', '21 CFR 211.160(a)', '21 CFR 211.25(a)', 21 CFR 211.192, '21 CFR 211.160(b)', '21 CFR 211.194(a)(2)', '21 CFR 211.68(b)', '21 CFR 211.165(a)']","['Lab controls established, including changes', Investigations made into any unexplained discrepancy, Test methods, Suitability of testing methods verified, In-process materials characteristics testing, 'Training--operations, GMPs, written procedures', Scientifically sound laboratory controls, Computer control of master formula records, Testing and release for distribution, Written procedures not established/followed, Quality control unit review of records, SOPs not followed / documented]",1636,Warning Letter,false,false,false,true |
| 3004259245,1091751,"G.N.R. Group Co., LTD.",2019-05-30,2019,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Yan Nawa,,,Thailand,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3004259245,4,"['21 CFR 120.8(b)(1)', '21 CFR 117.80(c)(8)', '21 CFR 120.8(b)(3)', '21 CFR 120.11(b)']","[HACCP plan - not validated, HACCP plan - food hazards not listed, HACCP plan - critical limits not listed or not adequate, Process control - Foreign objects]",1784,Warning Letter,false,false,false,true |
| 3012446166,670815,Happy Sprout Inc.,2010-07-09,2010,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Springfield,Virginia,VA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3012446166,2,"['21 CFR 110.20(b)(7)', '21 CFR 110.20(b)(1)']","[Screening, Sufficient space]",1972,Warning Letter,false,false,false,true |
| 3011390248,963500,Joy Gourmet Foods LLC.,2016-03-23,2016,Voluntary Action Indicated (VAI),VAI,Foodborne Biological Hazards,Food/Cosmetics,Yes,Maspeth,New York,NY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3011390248,6,"['21 CFR 110.20(b)(1)', '21 CFR 110.10(b)(1)', '21 CFR 110.80(b)(7)', '21 CFR 110.20(a)(1)', '21 CFR 110.20(b)(6)', '21 CFR 110.35(a)']","[Buildings/sanitary, Sufficient space, Suitable outer garments, Harborage areas, Adequate ventilation, 'Equipment, containers, utensils']",2151,Warning Letter,false,false,false,true |
| 1313046,563090,C.R. Bard Inc.,2009-02-18,2009,No Action Indicated (NAI),NAI,Compliance: Devices,Devices,No ,Queensbury,New York,NY,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=1313046,0,,,2336,Warning Letter,false,false,false,true |
| 3001237975,653137,Trapper's Creek Inc,2010-03-23,2010,No Action Indicated (NAI),NAI,Foodborne Biological Hazards,Food/Cosmetics,No ,Puyallup,Washington,WA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3001237975,0,,,2534,Warning Letter,false,false,false,true |
| 3002873473,673044,Kroger,2010-07-23,2010,No Action Indicated (NAI),NAI,Foodborne Biological Hazards,Food/Cosmetics,No ,Shelbyville,Indiana,IN,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3002873473,0,,,2771,Warning Letter,false,false,false,true |
| 3011382174,1008533,Uscom Kft,2017-03-30,2017,Voluntary Action Indicated (VAI),VAI,Compliance: Devices,Devices,Yes,Budapest,,,Hungary,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3011382174,3,"[21 CFR 803.17, '21 CFR 820.100(a)', '21 CFR 820.90(a)']","['Nonconforming product, Lack of or inadequate procedures', Lack of or inadequate procedures, Lack of Written MDR Procedures]",3042,Warning Letter,false,false,false,true |
| 3006676534,999219,"LiquidCapsule Manufacturing, LLC",2016-10-28,2017,Voluntary Action Indicated (VAI),VAI,"Food Composition, Standards, Labeling and Econ",Food/Cosmetics,Yes,Tampa,Florida,FL,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3006676534,6,"['21 CFR 111.15(c)(1)', '21 CFR 111.315(b)', '21 CFR 111.365(i)', 21 CFR 111.8, '21 CFR 111.123(b)(2)', '21 CFR 111.255(b)']","['Sampling plans; establish, follow', Batch record - complete, 'Quality control - batch, product specifications', Cleaning compounds, Written procedures - sick or infected personnel, 'Metal, foreign material']",3339,Warning Letter,false,false,false,true |
| 3008778303,742780,"Sabra Dipping Company, LLC",2011-09-01,2011,No Action Indicated (NAI),NAI,Foodborne Biological Hazards,Food/Cosmetics,No ,South Chesterfield,Virginia,VA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3008778303,0,,,3744,Warning Letter,false,false,false,true |
| 3004876794,673181,Accu Bio-Chem Laboratories LLC,2010-07-06,2010,Voluntary Action Indicated (VAI),VAI,Drug Quality Assurance,Drugs,Yes,Glendale,California,CA,United States,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3004876794,2,"['21 CFR 211.160(b)', '21 CFR 211.42(a)']","['Buildings of Suitable Size, Construction, Location', Scientifically sound laboratory controls]",4251,Warning Letter,false,false,false,true |
| 3006979678,787444,"Contec Medical Systems Co., Ltd.",2012-06-01,2012,Voluntary Action Indicated (VAI),VAI,Compliance: Devices,Devices,Yes,Qinhuangdao,,,China,https://datadashboard.fda.gov/oii/firmprofile.htm?FEIi=3006979678,5,"[21 CFR 820.184, '21 CFR 820.70(a)', '21 CFR 820.40(b)', '21 CFR 820.70(c)', '21 CFR 820.198(a)']","[Production processes, Environmental control Lack of or inadequate procedures, DHR content, Lack of or inadequate complaint procedures, 'Document change records, maintained.']",4871,Warning Letter,false,false,false,true |
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