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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 27, 2013 Wyeth Lederle S.p.A Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
March 27, 2013 Pranas Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 26, 2013 Comercializadora Segura de Cartago S.S.R. S.A Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
March 26, 2013 THD SpA Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *
March 26, 2013 Asociacion de Pequenos Agricultores Comalapenses de Producto Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions May 28, 2013
March 26, 2013 Safecross First Aid Ltd Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
March 25, 2013 Peking Medicine Manufactory Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Unapproved/Misbranded Not Issued *
March 25, 2013 Agnesian Healthcare IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
March 22, 2013 Mega Sun Inc Kansas City District Office CGMP for Medical Device/QSR/Adulterated Not Issued *
March 22, 2013 Asada Milling Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
March 22, 2013 Alexion Pharmaceuticals, Inc. New England District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
March 21, 2013 www.123smoke.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 26, 2013
March 21, 2013 paylessmoke.com@domainsbyproxy.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
March 21, 2013 Dr Gumbo's New Orleans Cuisine, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 21, 2013 www.123-cigs.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded May 01, 2013
March 21, 2013 George Nicolas Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded December 18, 2013
March 20, 2013 Dressel Farms, LLC New York District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 20, 2013 Finemost Corporation Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
March 20, 2013 Birkdale Medicinals LLC Detroit District Office Unapproved and Misbranded New Drugs March 06, 2014
March 20, 2013 Acclarent, Inc. San Francisco District Office Medical Device Reporting/Misbranded January 22, 2014



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