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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 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 Not Issued *
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 Not Issued *
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 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/Insanitary Conditions 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 Not Issued *
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



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