{"1010875":{"n":"C & S Wholesale Services, Inc.","v":"Jacksonville","e":"Florida","z":"32254","p":"United States","i":[["1058338","2018-06-20",2018,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0],["926933","2015-05-20",2015,"NAI","Food/Cosmetics","Foodborne Biological Hazards; Pesticides and Chemical Contaminants",0],["614823","2009-09-21",2009,"VAI","Drugs","Bioresearch Monitoring",1,"Postmarket Adverse Drug Experience (PADE)"]],"ci":{"614823":[["21 CFR 310.305(c)(2)","Investigation of serious, unexpected events","Serious, unexpected adverse drug experiences have not been promptly investigated.","Drugs"],["21 CFR 310.305(g)(3)","Lack of FDA access to records","An authorized FDA employee was not permitted, at a reasonable time, to have access to and copy and verify post marketing adverse drug experience records.","Drugs"],["21 CFR 314.80(b)","Failure to develop written procedures","Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of post marketing adverse drug experiences.","Drugs"]]}},"1031355":{"n":"Sysco Food Services of South Florida, Inc.","v":"Medley","e":"Florida","z":"33178","p":"United States","i":[["1127148","2020-07-01",2020,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0,"FSVP"],["1103253","2019-08-22",2019,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0,"FSVP"],["1050976","2018-05-07",2018,"VAI","Food/Cosmetics","Foodborne Biological Hazards",1,"FSVP"]],"ci":{"1050976":[["21 CFR 1.502(a)","Develop FSVP","You did not develop an FSVP.","Foods"]]}},"1481915":{"n":"Tortilleria El Milagro","v":"Chicago","e":"Illinois","z":"60608","p":"United States","i":[["763875","2012-01-19",2012,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"1522875":{"n":"Kapp Surgical Instrument Inc","v":"Warrensville Heights","e":"Ohio","z":"44128","p":"United States","i":[["1071836","2018-11-16",2019,"VAI","Devices","Compliance: Devices; Postmarket Assurance: Devices",1],["915420","2015-02-24",2015,"NAI","Devices","Compliance: Devices; Postmarket Assurance: Devices",0],["716182","2011-03-22",2011,"VAI","Devices","Compliance: Devices; Postmarket Assurance: Devices",1]],"ci":{"1071836":[["21 CFR 820.50","Purchasing controls, Lack of or inadequate procedures","Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.","Devices"],["21 CFR 820.70(a)","Process control procedures, Lack of or inadequate procedures","Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.","Devices"],["21 CFR 820.75(b)","Lack/Inad procedure-Monitoring/Control of Validated Proces","Procedures for monitoring and control of process parameters for a validated process have not been adequately established.","Devices"],["21 CFR 820.198(a)","Lack of or inadequate complaint procedures","Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.","Devices"]],"716182":[["21 CFR 820.120(d)","Mixups","Labeling and packaging operations were not controlled to prevent labeling mix-ups.","Devices"]]},"p5":5},"1911995":{"n":"Beachner Grain, Inc.","v":"Chanute","e":"Kansas","z":"66720","p":"United States","i":[["1120696","2020-01-16",2020,"NAI","Veterinary","Monitoring of Marketed Animal Drugs, Feed, and Devices",0]]},"2116795":{"n":"Revela Foods-Colby, LLC","v":"Colby","e":"Wisconsin","z":"54421","p":"United States","i":[["1309470","2026-02-26",2026,"NAI","Food/Cosmetics","Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards",0],["1082469","2019-02-13",2019,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0],["963501","2016-03-18",2016,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0],["897041","2014-09-24",2014,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0],["807081","2012-11-15",2013,"NAI","Food/Cosmetics","Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards",0],["772033","2012-03-13",2012,"NAI","Food/Cosmetics","Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards",0],["656845","2010-04-12",2010,"NAI","Food/Cosmetics","Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards",0],["595272","2009-07-02",2009,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"2129083":{"n":"Aitkin Feed & Farm Supply, Inc.","v":"Aitkin","e":"Minnesota","z":"56431","p":"United States","i":[["735385","2011-06-23",2011,"NAI","Veterinary","Monitoring of Marketed Animal Drugs, Feed, and Devices",0]]},"2940091":{"n":"United Airlines, Inc. - SFO","v":"San Francisco","e":"California","z":"94128","p":"United States","i":[["1048674","2018-04-17",2018,"VAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["1028473","2017-10-05",2018,"VAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["794243","2012-07-02",2012,"NAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["790366","2012-06-20",2012,"VAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["745440","2011-09-19",2011,"NAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["743391","2011-08-26",2011,"VAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["730459","2011-05-16",2011,"NAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["730451","2011-05-12",2011,"VAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["684659","2010-10-07",2011,"NAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["665246","2010-04-07",2010,"VAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["548308","2008-11-14",2009,"NAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0]]},"1000049851":{"n":"Brill Feed Mill","v":"Rice Lake","e":"Wisconsin","z":"54868","p":"United States","i":[["785426","2012-05-09",2012,"NAI","Veterinary","Monitoring of Marketed Animal Drugs, Feed, and Devices",0],["712292","2011-02-16",2011,"NAI","Veterinary","Monitoring of Marketed Animal Drugs, Feed, and Devices",0]]},"1000111291":{"n":"Atalys Asheboro LLC","v":"Asheboro","e":"North Carolina","z":"27205","p":"United States","i":[["1331708","2026-08-06",2026,"NAI","Devices","Compliance: Devices",0],["1147072","2021-07-23",2021,"VAI","Devices","Compliance: Devices; Postmarket Assurance: Devices",1],["1001762","2016-11-09",2017,"NAI","Devices","Compliance: Devices",0]],"ci":{"1147072":[["21 CFR 803.17","Lack of Written MDR Procedures","Written MDR procedures have not been developed.","Devices"],["21 CFR 820.100(b)","Documentation","Corrective and preventive action activities and/or results have not been adequately documented.","Devices"],["21 CFR 820.198(a)","Lack of or inadequate complaint procedures","Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.","Devices"]]}},"1000144059":{"n":"Gladwin Farms, Ltd.","v":"Abbotsford","e":"-","z":"-","p":"Canada","i":[["796178","2012-06-14",2012,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"1000512699":{"n":"McDonald Army Health Center","v":"Joint Base Langley-Fort Eustis","e":"Virginia","z":"23604","p":"United States","i":[["967249","2016-03-08",2016,"NAI","Biologics","Blood and Blood Products",0],["897396","2014-09-26",2014,"NAI","Biologics","Blood and Blood Products",0],["827464","2013-04-09",2013,"NAI","Biologics","Blood and Blood Products",0],["747010","2011-09-13",2011,"NAI","Biologics","Blood and Blood Products",0],["554785","2009-01-05",2009,"NAI","Biologics","Blood and Blood Products",0]]},"3003088059":{"n":"Intertek Testing Services NA Inc","v":"Twinsburg","e":"Ohio","z":"44087","p":"United States","i":[["749932","2011-10-06",2012,"OAI","Devices","Compliance: Devices",0]]},"3003722939":{"n":"York Pecan Company","v":"Foreman","e":"Arkansas","z":"71836","p":"United States","i":[["1024245","2017-08-16",2017,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0],["875347","2014-04-02",2014,"VAI","Food/Cosmetics","Foodborne Biological Hazards",0],["629367","2009-11-17",2010,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"3003944123":{"n":"Watson Pharmaceuticals Inc","v":"Corona","e":"California","z":"92880","p":"United States","i":[["747130","2011-09-27",2011,"VAI","Drugs","Bioresearch Monitoring",1,"Postmarket Adverse Drug Experience (PADE)"],["571474","2009-03-23",2009,"VAI","Drugs","Drug Quality Assurance",1]],"ci":{"747130":[["21 CFR 314.80(c)(1)(i)","Late submission of 15-day report","Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.","Drugs"],["21 CFR 314.80(c)(1)(ii)","Submission of report follow-up","Follow-up reports were not submitted within 15 calendar days of receipt of new information concerning post marketing 15-day reports.","Drugs"],["21 CFR 314.80(c)(2)","Late submission of annual safety reports","Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.","Drugs"],["21 CFR 314.80(c)(2)","Late submission of quarterly safety reports","Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.","Drugs"],["21 CFR 314.81(b)(1)(ii)","Contamination, chemical or physical change, deterioration","An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.","Drugs"]],"571474":[["21 CFR 211.22(c)","Approve or reject procedures or specs","The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.","Drugs"],["21 CFR 211.22(d)","Procedures not  in writing, fully followed","The responsibilities and procedures applicable to the quality control unit are not in writing.","Drugs"],["21 CFR 211.160(b)","Scientifically sound laboratory controls","Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.","Drugs"],["21 CFR 314.81(b)(1)(ii)","Contamination, chemical or physical change, deterioration","An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.","Drugs"]]}},"3003980987":{"n":"Reproductive Medicine & Infertility Associates","v":"Woodbury","e":"Minnesota","z":"55125","p":"United States","i":[["1257056","2024-12-16",2025,"NAI","Biologics","Human Cellular, Tissue, and Gene Therapies",0],["1071054","2018-10-24",2019,"NAI","Biologics","Blood and Blood Products; Human Cellular, Tissue, and Gene Therapies",0],["993117","2016-11-08",2017,"NAI","Biologics","Blood and Blood Products; Human Cellular, Tissue, and Gene Therapies",0],["919716","2015-03-19",2015,"NAI","Biologics","Human Cellular, Tissue, and Gene Therapies",0],["823583","2013-03-22",2013,"NAI","Biologics","Human Cellular, Tissue, and Gene Therapies",0],["746124","2011-09-20",2011,"VAI","Biologics","Human Cellular, Tissue, and Gene Therapies",1],["548297","2008-11-25",2009,"NAI","Biologics","Blood and Blood Products; Human Cellular, Tissue, and Gene Therapies",0]],"ci":{"746124":[["21 CFR 1271.47(a)","Procedures for all other requirements","Procedures for all steps performed in the testing, screening, and determining of donor eligibility of HCT/Ps were not established, defined, documented, and followed.","Human Tissue for Transplantation"]]}},"3004296379":{"n":"SunSelect Produce","v":"Aldergrove","e":"-","z":"-","p":"Canada","i":[["727921","2011-05-11",2011,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"3004308667":{"n":"EXPORTADORA ROMEX S.A.","v":"Lurigancho-Chosica","e":"-","z":"-","p":"Peru","i":[["935164","2015-04-01",2015,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"3004378299":{"n":"Quanta System SpA","v":"Solbiate Olona","e":"-","z":"-","p":"Italy","i":[["780939","2012-04-19",2012,"OAI","Devices","Compliance: Devices; Postmarket Assurance: Devices",1]],"ci":{"780939":[["21 CFR 803.17(b)(1)","Info evaluated to determine if event was reportable","The written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable.","Devices"],["21 CFR 820.22","Quality Audit/Reaudit - conducted","Quality reaudits have not been performed.","Devices"],["21 CFR 820.25(b)","Training - Lack of or inadequate procedures","Procedures for training and identifying training needs have not been established.","Devices"],["21 CFR 820.25(b)","Training records","Personnel training is not documented.","Devices"],["21 CFR 820.30(a)","Design control - no procedures","Procedures for design control have not been established.","Devices"],["21 CFR 820.40","Procedures not adequately established or maintained","Document control procedures have not been adequately established and maintained.","Devices"],["21 CFR 820.70(b)","Production and Process Change Procedures, lack of or Inad.","Procedures for changes to a process have not been established.","Devices"],["21 CFR 820.90(a)","Nonconforming product,  Lack of or inadequate procedures","Procedures have not been adequately established to control product that does not conform to specified requirements.","Devices"],["21 CFR 820.100(a)","Lack of or inadequate procedures","Procedures for corrective and preventive action have not been adequately established.","Devices"],["21 CFR 820.100(b)","Documentation","Corrective and preventive action activities and/or results have not been documented.","Devices"],["21 CFR 820.120(b)","DHR documentation of label release {see also 820.184}","The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.","Devices"],["21 CFR 820.198(a)","Lack of or inadequate complaint procedures","Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.","Devices"],["21 CFR 820.198(c)","Investigation of device failures","Complaints involving the possible failure of a device to meet any of its specifications were not evaluated and investigated where necessary.","Devices"],["21 CFR 820.200(b)","Analyzing service report","Service reports were not analyzed following appropriate statistical methods.","Devices"],["21 CFR 820.250(b)","Sampling methods - Lack of or inadequate procedures","Procedures to ensure sampling methods are adequate for their intended use have not been adequately established.","Devices"]]},"a":[["2012-10-18","Warning Letter","Devices","324318"]]},"3005074619":{"n":"The Kunkel Company, Inc.","v":"Eden Prairie","e":"Minnesota","z":"55344","p":"United States","i":[["1036807","2017-12-28",2018,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]],"p5":17},"3005250747":{"n":"Siemens Healthcare Diagnostics","v":"Los Angeles","e":"California","z":"90045","p":"United States","i":[["844212","2013-08-14",2013,"NAI","Devices","Compliance: Devices",0],["705533","2011-01-12",2011,"NAI","Devices","Compliance: Devices; Postmarket Assurance: Devices",0]]},"3005910203":{"n":"Atlantic Aviation - PSP","v":"Palm Springs","e":"California","z":"92262","p":"United States","i":[["1257711","2024-12-06",2025,"VAI","Food/Cosmetics","Foodborne Biological Hazards; Technical Assistance: Food and Cosmetics",0],["1004800","2017-01-10",2017,"VAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["892148","2014-08-21",2014,"VAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0],["740531","2011-08-15",2011,"NAI","Food/Cosmetics","Technical Assistance: Food and Cosmetics",0]]},"3006786747":{"n":"Oishi Koseido Co Ltd","v":"Tosu","e":"-","z":"-","p":"Japan","i":[["1037550","2017-12-06",2018,"NAI","Drugs","Drug Quality Assurance",0]]},"3006897339":{"n":"Phillips Farms","v":"Lebanon","e":"Tennessee","z":"37090","p":"United States","i":[["672863","2010-07-14",2010,"NAI","Veterinary","Monitoring of Marketed Animal Drugs, Feed, and Devices",0]]},"3007544507":{"n":"Drew-Massa Cooling, Inc.","v":"Salinas","e":"California","z":"93901","p":"United States","i":[["1218607","2023-08-23",2023,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"3007564987":{"n":"Marie A. Badalamente, M.D.","v":"Stony Brook","e":"New York","z":"11794","p":"United States","i":[["597698","2009-07-06",2009,"VAI","Drugs","Bioresearch Monitoring",0,"Clinical Investigator (CI)"]]},"3007851707":{"n":"IDD Tech","v":"Dardilly","e":"-","z":"-","p":"France","i":[["635695","2009-11-05",2010,"VAI","Drugs","Drug Quality Assurance",0]]},"3007950011":{"n":"John P. Nardandrea, M.D.","v":"Ocala","e":"Florida","z":"34470","p":"United States","i":[["1175069","2022-07-19",2022,"NAI","Drugs","Bioresearch Monitoring",0,"Clinical Investigator (CI)"]]},"3008212155":{"n":"Howling Helga's","v":"Rochester","e":"Minnesota","z":"55904","p":"United States","i":[["728644","2011-05-19",2011,"VAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"3008474299":{"n":"Bomboneria Di Perugia S.A.C.","v":"Lima","e":"-","z":"-","p":"Peru","i":[["936445","2015-03-31",2015,"VAI","Food/Cosmetics","Foodborne Biological Hazards",1]],"ci":{"936445":[["21 CFR 110.20(b)(4)","Floors, walls and ceilings","The plant is not constructed in such a manner as to allow floors and ceilings to be adequately cleaned and kept clean and kept in good repair.","Foods"],["21 CFR 110.35(b)(2)","Storage requirements","Failure to properly identify, hold, and store toxic cleaning compounds and sanitizing agents in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials.","Foods"],["21 CFR 110.37(e)(2)","Hand cleaning and sanitizing preparations","Lack of effective hand cleaning and sanitizing preparations.","Foods"],["21 CFR 110.80(b)(7)","Equipment, containers, utensils","Failure to handle and maintain equipment, containers and utensils used to hold and store food in a manner that protects against contamination.","Foods"],["21 CFR 110.80(b)(13)","Filling, assembling, packing controls","Failure to perform filling and assembling in a manner that protects food from becoming contaminated.","Foods"]]}},"3008978107":{"n":"Bruce Geiger","v":"Bad Axe","e":"Michigan","z":"48413","p":"United States","i":[["731133","2011-06-23",2011,"VAI","Veterinary","Monitoring of Marketed Animal Drugs, Feed, and Devices",1]],"ci":{"731133":[["21 CFR 530.11(a)","Dosage level","Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship.","Veterinary Medicine"],["21 CFR 530.11(a)","Route of administration","Administration of an approved animal drug via a route, subcutaneous, which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship.","Veterinary Medicine"],["21 CFR 530.11(d)","ELDU - producer causes Illegal drug residue","Causing a residue of an approved human or animal drug above an established safe level, safe concentration, or tolerance, through use of the drug contrary to its labeling.","Veterinary Medicine"],["FDCA 402(a)(4)","Drug inventory (control of drugs on premises)","You lack an adequate inventory system for determining the quantities of drugs used to medicate your livestock.","Veterinary Medicine"],["FDCA 402(a)(4)","System for administration of drugs","Failure to have a system to control administration of drug treatments to your animals.","Veterinary Medicine"],["FDCA 501(a)(5)","Expired drugs administered","Expired drug(s) were observed in the drug storage area.","Veterinary Medicine"]]}},"3009346747":{"n":"Prince Medical Industry SUARL","v":"Bizerte","e":"-","z":"-","p":"Tunisia","i":[["1194702","2022-12-15",2023,"NAI","Devices","Compliance: Devices; Postmarket Assurance: Devices",0],["776793","2012-04-02",2012,"OAI","Devices","Postmarket Assurance: Devices",0]],"a":[["2012-08-03","Warning Letter","Devices","321958"]]},"3009510587":{"n":"CNC S.A.C.","v":"Paita","e":"-","z":"-","p":"Peru","i":[["877638","2014-03-12",2014,"VAI","Food/Cosmetics; Veterinary","Foodborne Biological Hazards; Monitoring of Marketed Animal Drugs, Feed, and Devices",1]],"ci":{"877638":[["21 CFR 123.11(b)","Sanitation monitoring","You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including 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, and exclusion of pests.","Foods"]]}},"3009645755":{"n":"Tapia Brothers Co.","v":"N Las Vegas","e":"Nevada","z":"89030","p":"United States","i":[["1116144","2020-01-15",2020,"NAI","Food/Cosmetics","Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards",0]]},"3010047163":{"n":"Nor-Am North Cold Storage","v":"Le Mars","e":"Iowa","z":"51031","p":"United States","i":[["1179492","2022-08-09",2022,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"3010104507":{"n":"Zhicheng Jing","v":"Shanghai","e":"-","z":"-","p":"China","i":[["804168","2012-09-28",2012,"NAI","Drugs","Bioresearch Monitoring",0,"Clinical Investigator (CI)"]]},"3010223291":{"n":"Dexcowin Global Inc.","v":"Pasadena","e":"California","z":"91101","p":"United States","i":[["934629","2015-07-24",2015,"VAI","Devices","Compliance: Devices; Postmarket Assurance: Devices",1]],"ci":{"934629":[["21 CFR 803.17","Lack of Written MDR Procedures","Written MDR procedures have not been developed, maintained, and implemented.","Devices"],["21 CFR 803.18(d)(1)","Distributor responsibilities for complaint records","Device complaint records are not established and maintained by the device distributor, including any relevant incident information and information regarding the evaluation of the allegations.","Devices"],["21 CFR 820.198(a)","Lack of or inadequate complaint procedures","Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.","Devices"],["21 CFR 820.200(a)","Servicing - Lack of or inadequate procedures","Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements have not been established.","Devices"]]}},"3010931899":{"n":"Trapollo LLC","v":"Sterling","e":"Virginia","z":"20164","p":"United States","i":[["1111055","2019-11-21",2020,"VAI","Devices","Compliance: Devices",1],["978121","2016-07-25",2016,"VAI","Devices","Compliance: Devices",1]],"ci":{"1111055":[["21 CFR 820.20(c)","Management review - Lack of or inadequate procedures","Procedures for management review have not been adequately established.","Devices"],["21 CFR 820.22","Quality audits - Lack of or inadequate procedures","Procedures for quality audits have not been established.","Devices"],["21 CFR 820.50","Purchasing controls, Lack of or inadequate procedures","Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.","Devices"],["21 CFR 820.200(a)","Servicing - Lack of or inadequate procedures","Procedures or instructions for verifying that servicing meets specified requirements have not been adequately established.","Devices"]],"978121":[["21 CFR 820.100(a)","Lack of or inadequate procedures","Procedures for corrective and preventive action have not been adequately established.","Devices"]]}},"3011751099":{"n":"La Cabana Food Distributing, Inc.","v":"Oceanside","e":"California","z":"92058","p":"United States","i":[["1294046","2025-12-05",2026,"OAI","Food/Cosmetics","Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards",1],["1220391","2023-10-12",2024,"VAI","Food/Cosmetics","Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards",1]],"ci":{"1294046":[["21 CFR 117.37","Sanitary facilities and controls","Your plant did not have adequate sanitary facilities and accommodations.","Foods"],["21 CFR 117.93","Storage and Distribution","You did not store or transport a food under conditions that protect against contamination.","Foods"],["21 CFR 117.130(a)(1)","Hazard analysis - Identification of hazard","Your hazard analysis did not identify a hazard that required a preventive control.","Foods"],["21 CFR 117.135(a)(1)","Sanitation preventive controls - Implement","You did not implement your sanitation preventive control procedures.","Foods"],["21 CFR 117.135(c)(1)","Process preventive controls - Appropriate (Adequate)","Your written process preventive control, monitoring, corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control.","Foods"]],"1220391":[["21 CFR 117.10","Personnel","You did not take a reasonable measure or precaution related to personnel practices.","Foods"],["21 CFR 117.35(d)","Sanitation of food-contact surfaces - Frequency","You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against contamination of food.","Foods"]]},"a":[["2026-07-29","Warning Letter","Food/Cosmetics","724211"]]},"3011800251":{"n":"Josey Baker Bread","v":"San Francisco","e":"California","z":"94117","p":"United States","i":[["1320982","2026-06-01",2026,"VAI","Food/Cosmetics","Foodborne Biological Hazards",1],["1201038","2023-03-23",2023,"NAI","Food/Cosmetics","Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards",0]],"ci":{"1320982":[["21 CFR 117.135(a)(1)","Preventive controls - Implement (Limited Scope only)","You did not implement a process, allergen and sanitation preventive control.","Foods"]]},"p5":10},"3012598971":{"n":"Daryl Wehner","v":"Harbor Beach","e":"Michigan","z":"48441","p":"United States","i":[["1008170","2017-03-23",2017,"VAI","Veterinary","Monitoring of Marketed Animal Drugs, Feed, and Devices",1]],"ci":{"1008170":[["21 CFR 530.11(d)","ELDU - producer causes Illegal drug residue","Causing a residue of an approved human or animal drug above an established safe level, safe concentration, or tolerance, through use of the drug contrary to its labeling.","Veterinary Medicine"],["FDCA 402(a)(4)","Individual identity of animal(s)","Failure to maintain records regarding the identity of and record the existing identification of the animal(s) that you purchased and delivered for sale at an auction yard.","Veterinary Medicine"],["FDCA 402(a)(4)","Record keeping","Treatment records were not maintained.","Veterinary Medicine"],["FDCA 501(a)(5)","ELDU without veterinary client-patient relationship","Use of an animal drug in a manner contrary to label directions without benefit of a valid veterinary client-patient relationship.","Veterinary Medicine"]]}},"3013889211":{"n":"Gourmet's Delight Mushrooms, Inc.","v":"Eden","e":"Wisconsin","z":"53019","p":"United States","i":[["1170182","2022-05-16",2022,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0]]},"3015994555":{"n":"El-Jack Seif MD","v":"Takapuna","e":"-","z":"-","p":"New Zealand","i":[["1119505","2020-02-13",2020,"NAI","Devices","Bioresearch Monitoring",0,"Clinical Investigator (CI)"]]},"3025616059":{"n":"INTERNATIONAL FOOD MARKET INC","v":"Rochester","e":"New York","z":"14623","p":"United States","i":[["1255624","2024-12-10",2025,"NAI","Food/Cosmetics","Foodborne Biological Hazards",0,"FSVP"]]}}