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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 September 04, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 27, 2012 DPT Lakewood, LLC New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded February 19, 2013
August 27, 2012 Cendano Corporation Ltd. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 27, 2012 Indus Enterprises, Inc. d/b/a Texas Jasmine Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded October 16, 2012
August 24, 2012 Merge Healthcare New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 23, 2012 Madeleine Rausis Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 23, 2012 Stagnaro Bros Seafood Inc San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 23, 2012 Instratek, Incorporated Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 23, 2012 bioMerieux, Inc. Atlanta District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 23, 2012 Marks Marine Pharmacy Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
August 22, 2012 CoffeeCigarette.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 22, 2012 Global Biotechnologies, Inc. New England District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
August 22, 2012 Hospira Costa Rica Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 22, 2012 Cape Florida Seafood, Inc. Florida District Office Seafood HACCP/Adulterated Not Issued *
August 21, 2012 Jorge Dairy San Francisco District Office Illegal Drug Residue Not Issued *
August 20, 2012 Andy Winata Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 16, 2012 Old Fashioned Foods, Inc. Minneapolis District Office Low Acid Canned Food Regulation/Adulterated April 12, 2013
August 16, 2012 Farmers Coop Co Kansas City District Office CGMP/Medicated Feed/Adulterated March 13, 2013
August 16, 2012 Aladin Sweets & Market, Inc. Los Angeles District Office Seafood HACCP/Adulterated Not Issued *
August 16, 2012 IsoAid, L.L.C. Florida District Office CGMP/QSR/Adulterated Not Issued *
August 16, 2012 EEG Info Los Angeles District Office Device/Adulterated/Misbranded April 09, 2013


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