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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 Pacheco & Fagundes 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 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 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 Gutman Brothers, LTD Philadelphia District Office Illegal Drug Residue April 15, 2013
October 15, 2012 Gold Coast United, Inc. Baltimore District Office CGMP Regulation for Foods/Adulterated March 22, 2013
October 15, 2012 Alby's Seafood, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 15, 2012 Ortho Molecular Products Inc Minneapolis District Office New Drug/Labeling/Misbranded Not Issued *
October 15, 2012 BioNeurix Corporation Los Angeles District Office Dietary Supplement/Labeling/Misbranded Not Issued *
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 Skin Biology, Inc. Seattle District Office New Drug/Labeling/False & Misleading Claims Not Issued *
October 11, 2012 Atrium Medical Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 11, 2012 De Jong Dairy Seattle District Office Illegal Drug Residue Not Issued *
October 11, 2012 Finca Cojobas, Inc. San Juan District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
October 10, 2012 PC Tan Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *



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