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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 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



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