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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 October 02, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 12, 2012 C.C. & Son Farms, Incorporated San Francisco District Office PHS Act/Violation/Adulterated Not Issued *
September 12, 2012 Noble Anesthesia-Air, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 12, 2012 DMC Medical Technology & Manufacturing Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
September 11, 2012 EPS Biotechnology Corp. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 11, 2012 Roberts Ranch of Oklahoma LLC Dallas District Office Illegal Drug Residue Not Issued *
September 11, 2012 Mir-Com Products LLC Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated March 12, 2013
September 10, 2012 Gyrus ACMI, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 10, 2012 Monarch Seafoods, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
September 10, 2012 Global Source Management & Consulting Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
September 07, 2012 Unisis Corporation Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
September 07, 2012 Greek Island Labs Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
September 07, 2012 www.cigarettes-for-less.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
September 07, 2012 Lancome Center for Food Safety and Applied Nutrition New Drug Application [NDA] November 19, 2012
September 07, 2012 Fercy Personal Care Products Co., Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated & Failure to Register and List Not Issued *
September 07, 2012 SR Rosati, Inc. Philadelphia District Office CGMP Regulation For Foods/Adulterated/Misbranded February 28, 2013
September 07, 2012 www.cheapindonesiacigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 07, 2012
September 07, 2012 Chassy Bagels, Inc. dba House of Bagels, Inc. San Francisco District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
September 06, 2012 Quzhou Chemsyn Pharm Co Ltd Center for Drug Evaluation and Research Failure to Register and List  Not Issued *
September 06, 2012 Twin Oaks Dairy, LLC Philadelphia District Office Illegal Drug Residue Not Issued *
September 06, 2012 Thelen Livestock (Brad Thelen) Minneapolis District Office Illegal Drug Residue March 26, 2013


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