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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
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/Misbranding Not Issued *
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 *



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