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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 17, 2012 B & H Foods Inc Atlanta District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
October 17, 2012 Greencore USA, LLC New England District Office CGMP for Foods/Seafood HACCP/Adulterated April 05, 2013
October 16, 2012 Advanced Nutritional Technology Inc. San Francisco District Office CGMP/Dietary Supplement/Misbranding Not Issued *
October 16, 2012 Gomes Dairy San Francisco District Office Illegal Drug Residue Not Issued *
October 16, 2012 Hana Gourmet, Inc. dba Beyond Gourmet Dallas District Office Seafood HACCP/Adulterated August 13, 2013
October 16, 2012 Superfish S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
October 16, 2012 Nexera Medical, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 16, 2012 Quincy Bioscience Manufacturing Inc. Minneapolis District Office Unapproved and Misbranded New Drugs Not Issued *
October 15, 2012 Alby's Seafood, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 15, 2012 BioNeurix Corporation Los Angeles District Office Dietary Supplement/Labeling/Misbranded Not Issued *
October 15, 2012 Gold Coast United, Inc. Baltimore District Office CGMP Regulation for Foods/Adulterated March 22, 2013
October 15, 2012 Ortho Molecular Products Inc Minneapolis District Office New Drug/Labeling/Misbranded December 10, 2014
October 15, 2012 Gutman Brothers, LTD Philadelphia District Office Illegal Drug Residue April 15, 2013
October 12, 2012 Global Medical Holdings LLC Kansas City District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 12, 2012 www.clovecigarettesonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
October 11, 2012 Finca Cojobas, Inc. San Juan District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
October 11, 2012 Skin Biology, Inc. Seattle District Office New Drug/Labeling/False & Misleading Claims Not Issued *
October 11, 2012 De Jong Dairy Seattle District Office Illegal Drug Residue Not Issued *
October 11, 2012 Atrium Medical Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 10, 2012 Zian Medical, LLC Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *



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