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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 17, 2012 Neukom Groves, Inc. Florida District Office Juice HACCP May 07, 2013
May 17, 2012 Vienna Beauty Products Cincinnati District Office Cosmetics/Adulterated/Misbranded Not Issued *
May 17, 2012 The Lebanon Corp., Inc. Detroit District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation September 13, 2013
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 February 11, 2015
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
May 07, 2012 CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V. Center for Devices and Radiological Health Device/Adulterated July 19, 2012
May 07, 2012 Belmont Instrument Corporation Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded Not Issued *
May 07, 2012 ThermaSolutions Incorporated Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded Not Issued *
May 07, 2012 Quadex Pharmaceuticals, LLC Denver District Office OTC Drug Labeling/New Drug/Misbranded June 07, 2012
May 07, 2012 info@discount-cigarettes-online.biz Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 04, 2012 United Medical Center Baltimore District Office Mammography Quality Standards Not Issued *
May 04, 2012 B.M.P. Pharma Trading AG Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 03, 2012 Stingray Surgical Products, LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 03, 2012 Inova Health Care Services, Inova Blood Donor Services Baltimore District Office CGMP Regulation for Blood and Blood Products/Adulterated November 29, 2012
May 02, 2012 Andersen Sterilizers Inc Atlanta District Office Premarket Approval/Misbranded Not Issued *
May 02, 2012 Amplivox Ltd Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Adulterated Not Issued *
May 02, 2012 El Toro Farm Fresh Cheese Co. Atlanta District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
May 01, 2012 Stephen A. Langmaid Dallas District Office Illegal Drug Residue Not Issued *
May 01, 2012 Sea World, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 01, 2012 JC's Fish & BBQ Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 01, 2012 Freshwater Fish Products, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 16, 2013
May 01, 2012 Sulphur Springs Dairy Auction, Inc. Dallas District Office Illegal Drug Residue Not Issued *
May 01, 2012 O'Kroft Family Foods d.b.a. Willie B's Dallas District Office Acidified Foods/Adulterated Not Issued *
April 30, 2012 H & H Associates Baltimore District Office Device/Adulterated/Misbranded December 12, 2012
April 27, 2012 AJ Cigarettes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded May 14, 2012
April 27, 2012 Selder S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Misbranded March 28, 2014
April 27, 2012 Community Blood Centers of Florida, Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
April 27, 2012 Midwest Northem, Inc. Minneapolis District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated January 23, 2013
April 27, 2012 Community Blood Centers of Florida, Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
April 27, 2012 Riddle Brothers New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 26, 2012 Scariano Brothers, LLC New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
April 24, 2012 MuscleMeds Performance Technologies Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated April 19, 2015

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