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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 30, 2013 Gourmet Cuisine, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
January 30, 2013 H & H Seafood Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
January 29, 2013 FSSB Chirurgische Nadeln Gmbh Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *
January 29, 2013 M.D.R. Fitness Corp. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated October 18, 2013
January 29, 2013 www.cigrattesonlinebuy.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
January 29, 2013 www.ciggiesworld.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
January 29, 2013 P.A. Benjamin Manufacturing Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
January 29, 2013 Bellisio Foods Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
January 29, 2013 Sovereign Pharmaceuticals, LLC Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
January 29, 2013 M circle M Canning Co. Dallas District Office CGMP/Acidified Foods/Adulterated Not Issued *
January 29, 2013 CryoLife, Inc. Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
January 28, 2013 Bacterin International, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
January 28, 2013 Bacterin International, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded September 18, 2013
January 28, 2013 Paul K Katzmaier Philadelphia District Office Illegal Drug Residue July 11, 2013
January 25, 2013 Correia Dairy San Francisco District Office Illegal Drug Residue Not Issued *
January 25, 2013 Tecval Medical Sarl Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
January 25, 2013 SciLabs Nutraceuticals Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 25, 2013 R & D Ranch San Francisco District Office Illegal Drug Residue Not Issued *
January 25, 2013 NX Generation Ltd. New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 24, 2013 Flu & Cold Defense LLC Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season Not Issued *



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