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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 A&M De Sousa Dairy San Francisco District Office Illegal Drug Residue 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 Copan ltalia Center for Devices and Radiological Health Device/Adulterated 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 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 11, 2012 Lym-R-Flo Farm New York District Office Illegal Drug Residue January 04, 2013
May 10, 2012 Acorda Therapeutics Inc. New York District Office Adverse Drug Experience (ADE) Not Issued *
May 10, 2012 Human Biosciences, Inc. Baltimore District Office Premarket Approval/Misbranded August 12, 2013
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 www.online-dutyfree.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 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 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 07, 2012 ThermaSolutions Incorporated Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded Not Issued *



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