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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
May 17, 2012 Capitol Foods, Inc. Baltimore District Office Seafood HACCP/Adulterated/Misbranded Not Issued *
May 15, 2012 Smak Sp. z o.o. Center for Food Safety and Applied Nutrition Acidified Foods/Adulterated November 02, 2012
May 15, 2012 C.I. Farmacapsulas S.A. Center for Drug Evaluation and Research Failure to register and list November 29, 2012
May 14, 2012 Copan ltalia Center for Devices and Radiological Health Device/Adulterated Not Issued *
May 14, 2012 Caribe Natural LLC Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 14, 2012 A&M De Sousa Dairy San Francisco District Office Illegal Drug Residue Not Issued *
May 11, 2012 www.Low-Price-Cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 11, 2012 Lym-R-Flo Farm New York District Office Illegal Drug Residue January 04, 2013
May 11, 2012 Amor Nino Foods Inc San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 11, 2012 Classica Trading Center Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 10, 2012 Human Biosciences, Inc. Baltimore District Office Premarket Approval/Misbranded August 12, 2013
May 10, 2012 Acorda Therapeutics Inc. New York District Office Adverse Drug Experience (ADE) Not Issued *
May 10, 2012 Siemens Healthcare Diagnostics, Inc New England District Office CGMP/QSR/Medical Devices/Adulterated May 03, 2013
May 10, 2012 BTS S.p.A. Center for Devices and Radiological Health Device/Adulterated September 18, 2012
May 09, 2012 Terumo Medical Products Hangzhou Co., Ltd. Center for Devices and Radiological Health Adulterated Device June 11, 2013
May 08, 2012 Mediagnost GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 08, 2012 American Yeast Corp. Tennessee New Orleans District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
May 08, 2012 Reaction Nutrition, L.L.C. Philadelphia District Office CGMP for Dietary Supplements/Adulterated/Misbranded November 08, 2012
May 08, 2012 www.online-dutyfree.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 07, 2012 Millar Instruments, Inc. Dallas District Office Device/Adulterated July 05, 2013



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