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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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
December 08, 2011 Revolt Distribution Inc. Atlanta District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
December 07, 2011 Beck's Smokery Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 07, 2011 Sushi Avenue, Inc. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 31, 2012
December 06, 2011 Crown O'Maine Organic Cooperative New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 29, 2013
December 06, 2011 Italian Rose Garlic Products, Inc Florida District Office Acidified Foods/Acid Food Regulation/Adulterated/Insanitary Conditions October 26, 2012
December 06, 2011 FFE Transportation Services, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 06, 2011 Gresco Products, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated January 30, 2013
December 06, 2011 Med-Chem Labs Detroit District Office Promotional Claims False & Misleading/New Drugs Not Issued *
December 05, 2011 CooperVision, Inc. New York District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated July 05, 2012
December 05, 2011 Frog Island Seafood Inc Atlanta District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
December 05, 2011 Ion Labs Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
December 01, 2011 Precision Herbs, LLC Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
December 01, 2011 United States Cold Storage, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 01, 2011 DreamLife, LLC New Orleans District Office CGMP/Dietary Supplement/Adulterated Not Issued *
November 30, 2011 Middlebury Large Animal Clinic New England District Office Extralabel Drug Use In Animals/Adulterated Not Issued *
November 30, 2011 Antonio Resendes New England District Office Illegal Drug Residue Not Issued *
November 29, 2011 Silver Moon Springs LLC Minneapolis District Office Food Labeling/Misbranded Not Issued *
November 29, 2011 Merits Health Products Co., Ltd Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated January 30, 2013
November 28, 2011 Theoriginalhcgdrops.com New York District Office Homeopathic HCG Initiative Not Issued *
November 28, 2011 Nutri Fusion Systems, Inc Denver District Office Homeopathic HCG Initiative Not Issued *



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