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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 January 01, 2013

Letter Issue Date Company Name Issuing Office Subject Close Out Date
November 14, 2012 AloeScience Labs, Inc. Dallas District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *
November 13, 2012 Osachi 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 Not Issued *
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 A & D Electronics (Shenzhen) Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 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 Not Issued *
November 08, 2012 Pacific Northwest Tofu, LLC Seattle District Office CGMP for Foods/Adulterated Not Issued *
November 08, 2012 Phoenix Instruments, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated 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 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 The Avalon Effect Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
November 05, 2012 Women's Health Institute of Texas Dallas District Office New Drug/Misbranded 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 Atrium Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 02, 2012 Rigid FX Orthopedics, Inc Dallas 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 *


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