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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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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

Posted on May 16, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 16, 2011 duty-free-cigs.com Center for Tobacco Products Modified Risk Tobacco Products August 25, 2011
May 16, 2011 www.cheapcigarettesworld.com Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 Malton International LTD Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 cigarettes-online.biz 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 Nuvonyx, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 13, 2011 Import Food Wholesale Minneapolis District Office Seafood HACCP/CGMP for Food/Adulterated August 14, 2012
May 12, 2011 Hugh A Byron Cincinnati District Office Illegal Drug Residue December 13, 2011
May 12, 2011 Dawn's Foods, Inc. Minneapolis District Office Seafood HACCP/CGMP for Foods/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 Roman J. Bem Philadelphia District Office Illegal Drug Residue Not Issued *
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 *
May 09, 2011 Zuccaros Fruit and Produce Company, Inc. Minneapolis District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions August 14, 2012
May 09, 2011 Saemrow Dairy Minneapolis District Office Illegal Drug Residue October 17, 2011
May 06, 2011 Green Hope LLC dba Rosewood Detroit District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
May 06, 2011 ADAO, Inc. Denver District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
May 06, 2011 Ten Tea San Francisco District Office New Drug/Unauthorized Health Claims/Misbranded Not Issued *


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