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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
November 14, 2012 Stuart’s Seafood Market, Ltd. New York District Office CGMP for Foods/Adulterated Not Issued *
November 14, 2012 Shanghai Huhui Daily Use Chemical Products Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
November 14, 2012 John Stewart Horton New York District Office Illegal Drug Residue Not Issued *
November 14, 2012 www.smokeonthecheap.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded January 08, 2013
November 13, 2012 Mi Gwang Contact Lens Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
November 13, 2012 Langeland Farms Detroit District Office Illegal Drug Residue January 13, 2014
November 13, 2012 A & D Electronics (Shenzhen) Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated August 07, 2013
November 13, 2012 Osachi Co. Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
November 09, 2012 Chilam Yun Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
November 09, 2012 Blue Marine Seafoods Trading Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 08, 2012 HKH JVC LLC. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions July 08, 2013
November 08, 2012 Dzebovskaya, Yelena d/b/a Matrix Health Line Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
November 08, 2012 Phoenix Instruments, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated July 17, 2013
November 08, 2012 Pacific Northwest Tofu, LLC Seattle District Office CGMP for Foods/Adulterated Not Issued *
November 08, 2012 Triceutical Inc./Zhamg New York District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded Not Issued *
November 08, 2012 Lor-Rob Dairy Farm New York District Office Illegal Drug Residue Not Issued *
November 08, 2012 St Mary's Hospital and Medical Center, Inc. Denver District Office Federal Food Drug and Cosmetic Act Violations Not Issued *
November 06, 2012 CocoKefir, LLC Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated June 03, 2013
November 06, 2012 Tonica Elektronik A/S Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated/Misbranded Not Issued *
November 05, 2012 The Avalon Effect Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *



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