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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 31, 2012 Bracco Diagnostics Inc New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
January 31, 2012 BioElectronics Corporation Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 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 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 Universal Supplement, Inc. Los Angeles District Office CGMP Regulations for Dietary Supplements Not Issued *
January 30, 2012 Merit Medical Ireland Ltd. Center for Devices and Radiological Health Premarket Approval/Adulterated October 12, 2012
January 26, 2012 Ocean Food Company Limited Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
January 26, 2012 PhotoMedex, Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated March 19, 2013
January 25, 2012 Zhejiang Xianju Chemical Pharmaceutical Factory Center for Drug Evaluation and Research Failure to Register and List 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 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 Not Issued *
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 Mushroom Wisdom, Inc. New Jersey District Office False & Misleading Claims/New Drug Not Issued *
January 19, 2012 Spinal Solutiions, LLC Los Angeles District Office CGMP/QSR/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 Formulife, Inc.Purus Labs, Inc.d.b.a. Dark Cyde Supplements Dallas District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded Not Issued *



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