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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2011 Warning Letters

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Warning Letters issued in 2011

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 06, 2011 Omega Nutrition U.S.A., Inc. Seattle District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded December 15, 2011
April 06, 2011 Sometech Incorporated Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
April 06, 2011 Cache Creek Dairy San Francisco District Office Animals Sale for Slaughter as Food/Adulterated Not Issued *
April 06, 2011 Fresenius Medical Care Holdings, Inc Center for Devices and Radiological Health Device/Adulterated Not Issued *
April 06, 2011 Chesapeake Crab Connection Co Philadelphia District Office CGMP for Foods/Seafood HACCP/Adulterated/Misbranded October 06, 2011
April 05, 2011 UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) Atlanta District Office Premarket Approval/Misbranded/Adulterated Not Issued *
April 04, 2011 Meditherm Inc. Center for Devices and Radiological Health False & Misleading Claims/Misbranded Not Issued *
April 01, 2011 Del Bueno Seattle District Office Adulterated Food Not Issued *
April 01, 2011 Chantel's Cakes & Pastries Baltimore District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated October 17, 2011
March 31, 2011 Sam Hak Food Corp New York District Office CGMP for Foods/Seafood HACCP/Adulterated August 16, 2011
March 31, 2011 Proportional Technologies, Inc Dallas District Office Postion Emission Tomography (PET)/Adulterated August 17, 2012
March 31, 2011 HWW Enterprise Group Atlanta District Office Labeling/Therapeutic Claims Not Issued *
March 30, 2011 AloeElite Florida District Office New Drug/Misbranded Not Issued *
March 30, 2011 Ningbo Smart Pharmaceutical Co. Ltd. Center for Drug Evaluation and Research CGMP/Adulterated Not Issued *
March 29, 2011 Sanuki Kanzume Co Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated June 30, 2011
March 28, 2011 ARC Medical Supplies (Beijing) Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 28, 2011 Lena's Lefse, Inc. Minneapolis District Office Food Labeling/Misbranded January 31, 2012
March 28, 2011 Philips Medical Systems Seattle District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 28, 2011 Saw Palmetto Harvesting Co. Florida District Office New Drug/Misbranded Not Issued *
March 28, 2011 Drake Dairy, Inc. Minneapolis District Office Animals Sale for Slaughter as Food/Adulterated June 05, 2013



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