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

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