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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
May 16, 2011 Janis Larsen Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 General Project Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
May 16, 2011 AZCigs.com Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 cigarettesforless.com Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 Manolo and Son, LLC Baltimore District Office Seafood HACCP/Adulterated October 26, 2011
May 16, 2011 Contes Pasta Company, Inc. New Jersey District Office Seafood HACCP/CGMP for Food/Adulterated January 06, 2012
May 16, 2011 Church & Dwight Inc New Jersey District Office Medical Device Reporting/Misbranded June 27, 2012
May 16, 2011 duty-free-cigs.com Center for Tobacco Products Modified Risk Tobacco Products August 25, 2011
May 16, 2011 Anatolli Larionov Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 Pinsuwan Thanida Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 13, 2011 Hsu S Ginseng Enterprises Minneapolis District Office CGMP for Dietary Supplement/Adulterated February 06, 2012
May 13, 2011 Country Maid, Inc. Minneapolis District Office CGMP for Foods/Seafood HACCP April 12, 2013
May 13, 2011 Import Food Wholesale Minneapolis District Office Seafood HACCP/CGMP for Food/Adulterated August 14, 2012
May 13, 2011 Nuvonyx, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 12, 2011 Wisconsin Aluminum Foundry Co Minneapolis District Office CGMP for Medical Devices/QS/Adulterated July 06, 2012
May 12, 2011 Hugh A Byron Cincinnati District Office Illegal Drug Residue December 13, 2011
May 12, 2011 Roman J. Bem Philadelphia District Office Illegal Drug Residue October 26, 2011
May 12, 2011 Dawn's Foods, Inc. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated March 18, 2014
May 11, 2011 Do-n-Joy Holsteins Minneapolis District Office New Animal Drug/Adulterated Not Issued *
May 09, 2011 Omar Seafood, Corp Florida District Office Seafood HACCP/Adulterated Not Issued *



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