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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 30, 2012 Fresh Mushroom Farm Inc Kansas City District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions November 22, 2013
August 29, 2012 Sea One Enterprises, Inc. Cincinnati District Office CGMP for Foods/Adulterated Not Issued *
August 28, 2012 Regeneca, Inc Los Angeles District Office Dietary Supplement/Adulterated Not Issued *
August 28, 2012 Rell & Renn Seafood Sphere, Inc. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
August 28, 2012 Trinity Sports Group, Inc. Dallas District Office New Drug/Labeling/Misbranded Not Issued *
August 28, 2012 Creation's Garden Natural Products, Inc. Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
August 28, 2012 Blends Maker Mfg Inc. San Juan District Office HACCP/Adulterated Not Issued *
August 28, 2012 Wendell Corporation dba Regalo Bakery San Francisco District Office CGMP Regulation for Foods/Adulterated September 18, 2013
August 27, 2012 DPT Lakewood, LLC New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded February 19, 2013
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 27, 2012 Cendano Corporation Ltd. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 27, 2012 Naturavit, Inc. Florida District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded Not Issued *
August 27, 2012 PruTect Rx Denver District Office New Drug/Labeling/Misbranded August 29, 2013
August 24, 2012 Merge Healthcare New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 23, 2012 Marks Marine Pharmacy Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs 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 bioMerieux, Inc. Atlanta District Office CGMP/QSR/Medical Devices/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 22, 2012 CoffeeCigarette.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *



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