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

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