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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2014 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 08, 2014 Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 08, 2014 EnerHealth Botanicals, LLC Denver District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
August 08, 2014 Childrens Medical Ventures Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 08, 2014 Union Square Medical Imaging & Mammography New York District Office Mammography Quality Standards Not Issued *
August 08, 2014 Fessenden Dairy, LLC New York District Office Illegal Drug Residue Not Issued *
August 08, 2014 www.e-tobaccos.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 27, 2015
August 08, 2014 Nidek Inc San Francisco District Office CGMP/QSR/Medical Devices/Adulterated August 25, 2015
August 07, 2014 Colgate Oral Pharmaceuticals, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) August 21, 2014
August 07, 2014 Michigan Brands, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 07, 2014 Korea United Pharm Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) March 04, 2015
August 07, 2014 Explora Laboratories Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
August 06, 2014 Vernon W. Zimmerman Philadelphia District Office Illegal Drug Residue Not Issued *
August 05, 2014 Goodlife Juices Philadelphia District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions July 17, 2015
August 05, 2014 www.smokesfourless.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded December 02, 2014
August 05, 2014 o.m.t. Oberflachen - und Materialtechnologie Gmbh Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 05, 2014 Garden of Flavor LLC Cincinnati District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 07, 2016
August 05, 2014 Engineering Nutrition Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
August 04, 2014 Handsome Industrial (H.K.) Co., LTD Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 04, 2014 Vygon Gmbh & Co. KG Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 04, 2014 Oberholtzer, Joseph N. Philadelphia District Office Illegal Drug Residue August 04, 2015



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