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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
07/31/2012 Bob's Red Mill Natural Foods, Inc. Seattle District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
07/31/2012 Zarda Foods LLC Kansas City District Office CGMP/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
07/30/2012 Commed, Inc Seattle District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
07/30/2012 Grato, Inc. Kansas City District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded Not Issued *
07/30/2012 Infupharma, LLC Florida District Office CGMP for Finished Pharmaceutical/Adulterated 06/26/2013
07/30/2012 Jiangsu Province Jianerkang Medical Dressing Co. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 11/06/2014
07/27/2012 Curry's Bakery Inc. dba Pastry Perfection Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 02/19/2013
07/27/2012 AireRx Healthcare, LLC New Orleans District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
07/27/2012 Sanderlin, Damien MD Center for Biologics Evaluation and Research Clinical Investigator Not Issued *
07/26/2012 Royal King Infant Products Co., Ltd. Center for Devices and Radiological Health Adultered Device/Misbranding  Not Issued *
07/26/2012 A Nelson & Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 05/09/2016
07/26/2012 Philippine Cinmic Industrial Corp Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated 08/14/2012
07/25/2012 www.smoketobacco.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/25/2012 Horiba Instruments, Inc dba Horiba Medical Los Angeles District Office Premarket Approval/Adulterated/Misbranded 07/03/2013
07/24/2012 Cigs365.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/28/2012
07/24/2012 www.juicynewt.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/28/2012
07/24/2012 United Nutrition Labs, Inc. Philadelphia District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *
07/24/2012 Augustine Biomedical & Design, LLC Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded Not Issued *
07/23/2012 GM Manufacturing, Inc. Los Angeles District Office CGMP for Dietary Supplements/Adulterated Not Issued *
07/23/2012 Innovacyn Inc. Los Angeles District Office CGMP/New Animal Drugs/Adulterated/Unapproved 08/28/2013
07/20/2012 Lithia Mineral Water, Inc. Atlanta District Office Dietary Supplement/Adulterated Not Issued *
07/20/2012 Well – Delight Network Corporation Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated 08/14/2012
07/20/2012 Arriol International Corp. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 05/31/2013
07/19/2012 Vaqueria Ruben Gonzalez San Juan District Office Illegal Drug Residue 03/05/2013
07/19/2012 H & L Jerch Sales, Inc. Detroit District Office CGMP Regulations For Dietary Supplement/Adulterated 06/07/2013
07/18/2012 Meditech Kft. Center for Devices and Radiological Health Adulterated Device/Misbranded 06/15/2015
07/17/2012 Sybron Dental Specialties Center for Devices and Radiological Health Premarket Approval/Adulterated 10/02/2012
07/17/2012 Medtronic, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/16/2012 Quanta Aesthetic Lasers USA, LLC Center for Devices and Radiological Health Premarket Approval/Misbranded Not Issued *
07/16/2012 Ningbo Huahui Medical Instruments Co., LTD Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
07/16/2012 Gooten Innolife Corp Center for Devices and Radiological Health Adulterated Device/Misbranded Not Issued *
07/14/2012 Shijiazhuang Pharma. Group Zhongnuo Pharmaceuticals Co. Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
07/13/2012 Sincere Orient Commercial Foods Corp. Los Angeles District Office CGMP/Acidified Foods/Adulterated Not Issued *
07/13/2012 P.T. Super Saku Bali Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
07/12/2012 Brunner Farm Minneapolis District Office Illegal Drug Residue 04/19/2013
07/12/2012 Silva Foods Of Kansas City Kansas City District Office Acidified Foods/Acid Canned Food Regulation/Adulterated/Misbranded Not Issued *
07/12/2012 Sanofi Pasteur Center for Biologics Evaluation and Research CGMP Deviations 04/25/2014
07/12/2012 Alfa Vitamins Laboratories, Inc. Florida District Office New Drug/Labeling/False & Misleading Claims Not Issued *
07/11/2012 NeuroTherm, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/11/2012 Quantum Devices, Inc. Center for Devices and Radiological Health Device/Adulterated Not Issued *
07/11/2012 Leisegang Feinmechanik-Optik GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 05/26/2016
07/10/2012 Evol Nutrition Associates, Inc. Atlanta District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded Not Issued *
07/10/2012 The American Bottling Company, Inc. Dallas District Office Juice HACCP/Adulterated 04/17/2013
07/09/2012 www.storecigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/09/2012 Cutera Inc. Center for Devices and Radiological Health Device/Adulterated Not Issued *
07/09/2012 Ciresa Formaggi Snc Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
07/09/2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab Florida District Office Labeling/False & Misleading Claims/Misbranded/Adulterated/Insanitary Conditions Not Issued *
07/09/2012 Ronald Andio, DBA Patron Farms, LLC Cincinnati District Office Illegal Drug Residue Not Issued *
07/06/2012 Vincent Piazza, Jr. & Sons Seafood, Inc. New Orleans District Office CGMP for Foods/Adulterated 05/01/2014
07/05/2012 Caseificio Sociale Manciano Center for Food Safety and Applied Nutrition CGMP for Food/Adulterated Not Issued *

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