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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
November 14, 2012 www.smokeonthecheap.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded January 08, 2013
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 Bradley Industries, Inc. Minneapolis District Office Food Labeling/Adulterated/Misbranded April 07, 2014
November 14, 2012 Stuart’s Seafood Market, Ltd. New York District Office CGMP for Foods/Adulterated Not Issued *
November 14, 2012 John Stewart Horton New York District Office Illegal Drug Residue Not Issued *
November 13, 2012 Osachi Co. Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded November 13, 2015
November 13, 2012 Langeland Farms Detroit District Office Illegal Drug Residue January 13, 2014
November 13, 2012 Mi Gwang Contact Lens Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded September 14, 2015
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 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 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 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 HKH JVC LLC. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions July 08, 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 06, 2012 CocoKefir, LLC Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated June 03, 2013
November 05, 2012 Women's Health Institute of Texas Dallas District Office New Drug/Misbranded November 06, 2013
November 05, 2012 The Avalon Effect Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
November 02, 2012 Rigid FX Orthopedics, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 02, 2012 Shinhan F&B Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 02, 2012 oBand Centers Westwood, CA Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
November 02, 2012 Ansar Group, Inc. d/b/a Ansar Medical Technologies, Inc Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 02, 2012 Ito En (USA) Inc. San Francisco District Office Low Acid Canned Food Regulation/Adulterated May 21, 2015
November 02, 2012 Atrium Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 01, 2012 Ritter's Fish Market Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions July 29, 2013
November 01, 2012 Bay View Packing Co Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions August 16, 2013
November 01, 2012 Integra NeuroSciences Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated June 30, 2015
November 01, 2012 Alex Freeman Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
November 01, 2012 Marine Foods Express, LTD Dallas District Office CGMP for Foods/Adulterated September 25, 2013
October 30, 2012 Caito Fisheries Inc San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 29, 2012 PerioSeal, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 26, 2012 DMX-Works, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated July 23, 2013
October 26, 2012 www.indonesia-cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
October 26, 2012 National Food & Beverage, Inc Dallas District Office Acidified Foods/Acid Canned Food Regulation/Adulterated February 26, 2014
October 25, 2012 William C. Domb, D.M.D., A Professional Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 25, 2012 www.brandcigarettes4cheap.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded April 01, 2015
October 25, 2012 www.cheapcigarettesonline.us Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded February 06, 2013
October 25, 2012 www.smoke-mall.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 15, 2012
October 24, 2012 ABH Nature's Products, Inc. New York District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded Not Issued *
October 24, 2012 U.S.A Far Ocean Group LLC/Health & Beauty Group Inc. Los Angeles District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
October 23, 2012 Finger Lakes Farmstead Cheese Company LLC New York District Office CGMP Regulation For Food/Adulterated Not Issued *
October 23, 2012 Westone Laboratories Incorporated Denver District Office CGMP/QSR/Medical Devices/Adulterated September 10, 2013
October 23, 2012 Phil Jon Farms Philadelphia District Office Illegal Drug Residue May 08, 2013
October 23, 2012 Hail Merry, LLC Dallas District Office Food Labeling/False & Misleading/Misbranded Not Issued *
October 23, 2012 International Laboratories (Canada) Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
October 22, 2012 Sugih Instrumendo Abadi, PT. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *

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