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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
11/14/2012 www.smokeonthecheap.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 01/08/2013
11/14/2012 John Stewart Horton New York District Office Illegal Drug Residue Not Issued *
11/14/2012 Stuart’s Seafood Market, Ltd. New York District Office CGMP for Foods/Adulterated Not Issued *
11/14/2012 Shanghai Huhui Daily Use Chemical Products Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
11/14/2012 Bradley Industries, Inc. Minneapolis District Office Food Labeling/Adulterated/Misbranded 04/07/2014
11/13/2012 Langeland Farms Detroit District Office Illegal Drug Residue 01/13/2014
11/13/2012 Osachi Co. Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 11/13/2015
11/13/2012 A & D Electronics (Shenzhen) Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 08/07/2013
11/13/2012 Mi Gwang Contact Lens Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 09/14/2015
11/09/2012 Chilam Yun Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
11/09/2012 Blue Marine Seafoods Trading Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated 12/10/2012
11/08/2012 Triceutical Inc./Zhamg New York District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded Not Issued *
11/08/2012 Lor-Rob Dairy Farm New York District Office Illegal Drug Residue Not Issued *
11/08/2012 St Mary's Hospital and Medical Center, Inc. Denver District Office Federal Food Drug and Cosmetic Act Violations Not Issued *
11/08/2012 HKH JVC LLC. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 07/08/2013
11/08/2012 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 *
11/08/2012 Phoenix Instruments, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated 07/17/2013
11/08/2012 Pacific Northwest Tofu, LLC Seattle District Office CGMP for Foods/Adulterated Not Issued *
11/06/2012 CocoKefir, LLC Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 06/03/2013
11/06/2012 Tonica Elektronik A/S Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated/Misbranded Not Issued *
11/05/2012 Women's Health Institute of Texas Dallas District Office New Drug/Misbranded 11/06/2013
11/05/2012 The Avalon Effect Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
11/02/2012 Rigid FX Orthopedics, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/02/2012 oBand Centers Westwood, CA Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
11/02/2012 Atrium Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
11/02/2012 Ito En (USA) Inc. San Francisco District Office Low Acid Canned Food Regulation/Adulterated 05/21/2015
11/02/2012 Shinhan F&B Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/02/2012 Ansar Group, Inc. d/b/a Ansar Medical Technologies, Inc Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/01/2012 Marine Foods Express, LTD Dallas District Office CGMP for Foods/Adulterated 09/25/2013
11/01/2012 Bay View Packing Co Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 08/16/2013
11/01/2012 Alex Freeman Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
11/01/2012 Integra NeuroSciences Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 06/30/2015
11/01/2012 Ritter's Fish Market Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 07/29/2013
10/30/2012 Caito Fisheries Inc San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/29/2012 PerioSeal, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/26/2012 www.indonesia-cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/26/2012 DMX-Works, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated 07/23/2013
10/26/2012 National Food & Beverage, Inc Dallas District Office Acidified Foods/Acid Canned Food Regulation/Adulterated 02/26/2014
10/25/2012 William C. Domb, D.M.D., A Professional Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
10/25/2012 www.brandcigarettes4cheap.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/01/2015
10/25/2012 www.smoke-mall.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/15/2012
10/25/2012 www.cheapcigarettesonline.us Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 02/06/2013
10/24/2012 ABH Nature's Products, Inc. New York District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded Not Issued *
10/24/2012 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 *
10/23/2012 Finger Lakes Farmstead Cheese Company LLC New York District Office CGMP Regulation For Food/Adulterated Not Issued *
10/23/2012 Westone Laboratories Incorporated Denver District Office CGMP/QSR/Medical Devices/Adulterated 09/10/2013
10/23/2012 International Laboratories (Canada) Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
10/23/2012 Hail Merry, LLC Dallas District Office Food Labeling/False & Misleading/Misbranded Not Issued *
10/23/2012 Phil Jon Farms Philadelphia District Office Illegal Drug Residue 05/08/2013
10/22/2012 Health Breakthroughs International, LLC Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *

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