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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
July 13, 2012 P.T. Super Saku Bali Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
July 12, 2012 Alfa Vitamins Laboratories, Inc. Florida District Office New Drug/Labeling/False & Misleading Claims Not Issued *
July 12, 2012 Brunner Farm Minneapolis District Office Veterinary Medicine/Misbranded April 19, 2013
July 12, 2012 Silva Foods Of Kansas City Kansas City District Office Acidified Foods/Acid Canned Food Regulation/Adulterated/Misbranded Not Issued *
July 12, 2012 Sanofi Pasteur Center for Biologics Evaluation and Research CGMP Deviations April 25, 2014
July 11, 2012 Quantum Devices, Inc. Center for Devices and Radiological Health Device/Adulterated Not Issued *
July 11, 2012 Leisegang Feinmechanik-Optik GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 11, 2012 NeuroTherm, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 10, 2012 Evol Nutrition Associates, Inc. Atlanta District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded Not Issued *
July 10, 2012 The American Bottling Company, Inc. Dallas District Office Juice HACCP/Adulterated April 17, 2013
July 09, 2012 Ronald Andio, DBA Patron Farms, LLC Cincinnati District Office Illegal Drug Residue Not Issued *
July 09, 2012 www.storecigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 09, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab Florida District Office Labeling/False & Misleading Claims/Misbranded/Adulterated/Insanitary Conditions Not Issued *
July 09, 2012 Cutera Inc. Center for Devices and Radiological Health Device/Adulterated Not Issued *
July 09, 2012 Ciresa Formaggi Snc Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
July 06, 2012 Vincent Piazza, Jr. & Sons Seafood, Inc. New Orleans District Office CGMP for Foods/Adulterated May 01, 2014
July 05, 2012 Caseificio Sociale Manciano Center for Food Safety and Applied Nutrition CGMP for Food/Adulterated Not Issued *
July 05, 2012 Kasa's Food Distributing Co. Philadelphia District Office Food Labeling/Misbranded December 11, 2012
July 03, 2012 Center for the Improvement of Human Functioning International, Inc. IRB Center for Drug Evaluation and Research Institutional Review Board (IRB). Not Issued *
July 03, 2012 New Rich City Co. Philadelphia District Office CGMP for Foods/Adulterated Not Issued *



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