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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2012 Warning Letters

Posted on August 07, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 27, 2012 Damien Sanderlin, MD Center for Biologics Evaluation and Research Clinical Investigator Not Issued *
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 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 Not Issued *
July 26, 2012 A Nelson & Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
July 25, 2012 Horiba Instruments, Inc dba Horiba Medical Los Angeles District Office Premarket Approval/Adulterated/Misbranded Not Issued *
July 25, 2012 www.smoketobacco.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 24, 2012 Augustine Biomedical & Design, LLC Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded Not Issued *
July 24, 2012 United Nutrition Labs, Inc. Philadelphia District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *
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 23, 2012 Innovacyn Inc. Los Angeles District Office CGMP/New Animal Drugs/Adulterated/Unapproved Not Issued *
July 23, 2012 GM Manufacturing, Inc. Los Angeles District Office CGMP for Dietary Supplements/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 Lithia Mineral Water, Inc. Atlanta District Office Dietary Supplement/Adulterated Not Issued *
July 20, 2012 Arriol International Corp. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/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 *


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