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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 Commed, Inc Seattle District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded 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 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 AireRx Healthcare, LLC New Orleans District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
July 27, 2012 Sanderlin, Damien MD Center for Biologics Evaluation and Research Clinical Investigator 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 A Nelson & Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded May 09, 2016
July 26, 2012 Philippine Cinmic Industrial Corp Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated August 14, 2012
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 Cigs365.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 28, 2012
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 United Nutrition Labs, Inc. Philadelphia District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *
July 24, 2012 Augustine Biomedical & Design, LLC Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded Not Issued *
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 Lithia Mineral Water, Inc. Atlanta District Office Dietary Supplement/Adulterated Not Issued *
July 20, 2012 Well – Delight Network Corporation Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated August 14, 2012
July 20, 2012 Arriol International Corp. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated May 31, 2013
July 19, 2012 Vaqueria Ruben Gonzalez San Juan District Office Illegal Drug Residue March 05, 2013
July 19, 2012 H & L Jerch Sales, Inc. Detroit District Office CGMP Regulations For Dietary Supplement/Adulterated June 07, 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 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 16, 2012 Gooten Innolife Corp Center for Devices and Radiological Health Adulterated Device/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 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 Sanofi Pasteur Center for Biologics Evaluation and Research CGMP Deviations April 25, 2014
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 Evol Nutrition Associates, Inc. Atlanta District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded Not Issued *
July 10, 2012 The American Bottling Company, Inc. Dallas District Office Juice HACCP/Adulterated April 17, 2013
July 09, 2012 www.storecigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 09, 2012 Cutera Inc. Center for Devices and Radiological Health Device/Adulterated 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 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 Ronald Andio, DBA Patron Farms, LLC Cincinnati District Office Illegal Drug Residue 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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