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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
02/14/2012 Omron (Dalian) Co., Ltd. Plant 1 Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated Not Issued *
02/14/2012 Ginsberg's Institutional Foods, Inc. New York District Office Seafood HACCP/Adulterated 08/01/2012
02/14/2012 Edge Biologicals, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated 03/25/2015
02/14/2012 The Hershey Company Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
02/13/2012 Meadowlark Dairy L.L.C. Minneapolis District Office Illegal Drug Residue 04/13/2012
02/12/2012 I.E.M. GmbH Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
02/09/2012 Mirrotek International, LLC New Jersey District Office Acidified Foods/Emergency Permit Control/Adulterated 08/20/2012
02/09/2012 Home Care Technologies USA, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 10/19/2012
02/09/2012 Pork Champ, LLC Cincinnati District Office Illegal Drug Residue Not Issued *
02/09/2012 BioAnue Laboratories, Inc. Atlanta District Office Dietary supplement/New Drug Not Issued *
02/08/2012 Probed Medical Technologies, Inc. Center for Devices and Radiological Health Adulterated Device 08/28/2012
02/08/2012 Donut Factory, LLC. Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 05/01/2012
02/08/2012 Tree Top, Inc. Seattle District Office Adulterated Food Not Issued *
02/08/2012 Intelligent Hospital Systems Center for Devices and Radiological Health Adulterated Device 06/19/2013
02/08/2012 Vitaganic Inc. San Francisco District Office Current Good Manufacturing Practice/Dietary Supplements/Adulterated Not Issued *
02/07/2012 Fieser Dairy, Inc. Florida District Office Illegal Drug Residue Not Issued *
02/07/2012 Blossom Enterprises LLC d/b/a Sea Blossom Seafoods Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/06/2012 Globe All Wellness, LLC Florida District Office New Drugs/Dietary Supplements/Misbranded Not Issued *
02/06/2012 Productos del Convento, S.A. de C.V. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
02/03/2012 West-Ward Pharmaceuticals Corp. New Jersey District Office CGMP for Finished Pharmaceuticals/Adulterated 03/26/2014
02/03/2012 Ken Gonnering Livestock, Inc. Minneapolis District Office Illegal Drug Residue 02/24/2012
02/03/2012 Orthopedic Alliance Los Angeles District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
02/01/2012 Tobacco Source Three LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/18/2012
02/01/2012 Chuctanuda Farms New York District Office Illegal Drug Residue 02/15/2013
02/01/2012 Advanced Surgical Design & Manufacture, Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/31/2012 Alimex Sa Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/27/2012
01/31/2012 Bracco Diagnostics Inc New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
01/31/2012 CAW Industries, Inc. Minneapolis District Office Labeling/Misbranded 04/12/2013
01/31/2012 BioElectronics Corporation Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
01/31/2012 Conservas La Torre S.A. de C.V. Center for Food Safety and Applied Nutrition Acidified Foods/Acid Canned Food Regulation/Adulterated/Misbranded 06/05/2012
01/30/2012 Universal Supplement, Inc. Los Angeles District Office CGMP Regulations for Dietary Supplements Not Issued *
01/30/2012 LifeSouth Community Blood Centers, Inc. New Orleans District Office CGMP for Blood & Blood Products/Adulterated Not Issued *
01/30/2012 Merit Medical Ireland Ltd. Center for Devices and Radiological Health Premarket Approval/Adulterated 10/12/2012
01/26/2012 Ocean Food Company Limited Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
01/26/2012 PhotoMedex, Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated 03/19/2013
01/25/2012 Zhejiang Xianju Chemical Pharmaceutical Factory Center for Drug Evaluation and Research Failure to Register and List Not Issued *
01/25/2012 Seattle Roll Bakery Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
01/24/2012 Pescaderia La Marinera del 23 SA de CV Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
01/23/2012 Negocios Industriales Real "N.I.R.S.A.", S.A. Center for Food Safety and Applied Nutrition CGMP Regulation For Food/Adulterated Not Issued *
01/23/2012 Douty Brothers, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated 08/06/2015
01/20/2012 Visoy Food, Inc. Los Angeles District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
01/20/2012 Flying Food Group, Inc. New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 07/23/2013
01/19/2012 Spinal Solutiions, LLC Los Angeles District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
01/19/2012 Mushroom Wisdom, Inc. New Jersey District Office False & Misleading Claims/New Drug Not Issued *
01/18/2012 LushLife Gardens New Jersey District Office Unsanitary Conditions/Adulterated 04/09/2013
01/18/2012 Almased USA, Inc. Florida District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
01/18/2012 Formulife, Inc.Purus Labs, Inc.d.b.a. Dark Cyde Supplements Dallas District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded Not Issued *
01/17/2012 Hillside Veal Philadelphia District Office Illegal Drug Residue 11/21/2013
01/17/2012 Creekside Springs LLC Cincinnati District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
01/17/2012 Landshire, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/06/2013

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