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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 Augustine Biomedical & Design, LLC Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded 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 Cigs365.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 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 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/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 Ningbo Huahui Medical Instruments Co., LTD Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/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 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 P.T. Super Saku Bali Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *



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