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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
05/18/2012 Arrowhead DE LLC, DBA Arrowhead Medical Device Technologies New Orleans District Office CGMP/QSR/Medical Devices/Adulterated 04/16/2013
05/17/2012 Neukom Groves, Inc. Florida District Office Juice HACCP 05/07/2013
05/17/2012 Vienna Beauty Products Cincinnati District Office Cosmetics/Adulterated/Misbranded Not Issued *
05/17/2012 The Lebanon Corp., Inc. Detroit District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation 09/13/2013
05/17/2012 Capitol Foods, Inc. Baltimore District Office Seafood HACCP/Adulterated/Misbranded Not Issued *
05/15/2012 Smak Sp. z o.o. Center for Food Safety and Applied Nutrition Acidified Foods/Adulterated 11/02/2012
05/15/2012 C.I. Farmacapsulas S.A. Center for Drug Evaluation and Research Failure to register and list 11/29/2012
05/14/2012 Copan ltalia Center for Devices and Radiological Health Device/Adulterated 02/11/2015
05/14/2012 Caribe Natural LLC Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
05/14/2012 A&M De Sousa Dairy San Francisco District Office Illegal Drug Residue Not Issued *
05/11/2012 www.Low-Price-Cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/11/2012 Lym-R-Flo Farm New York District Office Illegal Drug Residue 01/04/2013
05/11/2012 Amor Nino Foods Inc San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/11/2012 Classica Trading Center Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/10/2012 Human Biosciences, Inc. Baltimore District Office Premarket Approval/Misbranded 08/12/2013
05/10/2012 Acorda Therapeutics Inc. New York District Office Adverse Drug Experience (ADE) Not Issued *
05/10/2012 Siemens Healthcare Diagnostics, Inc New England District Office CGMP/QSR/Medical Devices/Adulterated 05/03/2013
05/10/2012 BTS S.p.A. Center for Devices and Radiological Health Device/Adulterated 09/18/2012
05/09/2012 Terumo Medical Products Hangzhou Co., Ltd. Center for Devices and Radiological Health Adulterated Device 06/11/2013
05/08/2012 Mediagnost GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/08/2012 American Yeast Corp. Tennessee New Orleans District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
05/08/2012 Reaction Nutrition, L.L.C. Philadelphia District Office CGMP for Dietary Supplements/Adulterated/Misbranded 11/08/2012
05/08/2012 www.online-dutyfree.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/07/2012 Millar Instruments, Inc. Dallas District Office Device/Adulterated 07/05/2013
05/07/2012 CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V. Center for Devices and Radiological Health Device/Adulterated 07/19/2012
05/07/2012 Belmont Instrument Corporation Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded Not Issued *
05/07/2012 ThermaSolutions Incorporated Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded Not Issued *
05/07/2012 Quadex Pharmaceuticals, LLC Denver District Office OTC Drug Labeling/New Drug/Misbranded 06/07/2012
05/07/2012 info@discount-cigarettes-online.biz Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/04/2012 United Medical Center Baltimore District Office Mammography Quality Standards Not Issued *
05/04/2012 B.M.P. Pharma Trading AG Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/03/2012 Stingray Surgical Products, LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/03/2012 Inova Health Care Services, Inova Blood Donor Services Baltimore District Office CGMP Regulation for Blood and Blood Products/Adulterated 11/29/2012
05/02/2012 Andersen Sterilizers Inc Atlanta District Office Premarket Approval/Misbranded Not Issued *
05/02/2012 Amplivox Ltd Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Adulterated Not Issued *
05/02/2012 El Toro Farm Fresh Cheese Co. Atlanta District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
05/01/2012 Stephen A. Langmaid Dallas District Office Illegal Drug Residue Not Issued *
05/01/2012 Sea World, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/01/2012 JC's Fish & BBQ Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/01/2012 Freshwater Fish Products, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/16/2013
05/01/2012 Sulphur Springs Dairy Auction, Inc. Dallas District Office Illegal Drug Residue Not Issued *
05/01/2012 O'Kroft Family Foods d.b.a. Willie B's Dallas District Office Acidified Foods/Adulterated Not Issued *
04/30/2012 H & H Associates Baltimore District Office Device/Adulterated/Misbranded 12/12/2012
04/27/2012 AJ Cigarettes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 05/14/2012
04/27/2012 Selder S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Misbranded 03/28/2014
04/27/2012 Community Blood Centers of Florida, Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
04/27/2012 Midwest Northem, Inc. Minneapolis District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated 01/23/2013
04/27/2012 Community Blood Centers of Florida, Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/27/2012 Riddle Brothers New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/26/2012 Scariano Brothers, LLC New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *

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