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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2012 Warning Letters

Posted on February 28, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
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
February 01, 2012 Chuctanuda Farms New York District Office Illegal Drug Residue February 15, 2013
January 31, 2012 BioElectronics Corporation Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
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 31, 2012 CAW Industries, Inc. Minneapolis District Office Labeling/Misbranded April 12, 2013
January 30, 2012 Universal Supplement, Inc. Los Angeles District Office CGMP Regulations for Dietary Supplements Not Issued *
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 26, 2012 PhotoMedex, Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
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 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 23, 2012 Douty Brothers, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 20, 2012 Flying Food Group, Inc. New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
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 *


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