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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

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
05/27/2011 AngioDynamics, Inc. [ARCHIVED] New York District Office Medical Device Reporting Regulation/Misbranded 11/25/2015
05/27/2011 Nature Pure LLC [ARCHIVED] Cincinnati District Office PHS Act/Violation 01/11/2012
05/26/2011 Vipamat Technologie [ARCHIVED] Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Adulterated/Misbranded 05/01/2015
05/25/2011 Lumen Soy Foods, LLC [ARCHIVED] New Orleans District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated 05/24/2012
05/25/2011 Cellular Rx Inc [ARCHIVED] Kansas City District Office New Drug/Misbranded Not Issued *
05/25/2011 Ethos Environmental Inc dba Regeneca International Inc [ARCHIVED] Los Angeles District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
05/24/2011 Allure Labs, Inc. [ARCHIVED] San Francisco District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
05/23/2011 Cerebral Health, LLC [ARCHIVED] Florida District Office CGMP for Dietary Supplements/Adulterated Not Issued *
05/23/2011 Compass International Innovations Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated 12/06/2011
05/23/2011 Union Springs Pharmaceuticals, LLC [ARCHIVED] Center for Drug Evaluation and Research Internet Unapproved Drug/Misbranded Not Issued *
05/23/2011 Knight Feedlot Inc [ARCHIVED] Kansas City District Office CGMP Regulation for Medicated Feeds/Adulterated Not Issued *
05/20/2011 National Bakery Inc [ARCHIVED] Philadelphia District Office Food Labeling/Misbranded 06/22/2012
05/20/2011 Aurobindo Pharma Limited [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/20/2011 Larry Bourdeau / Windy Acres Farm [ARCHIVED] New England District Office Illegal Drug Residue 06/21/2011
05/19/2011 Bilow Farms, LLC [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
05/19/2011 Facet Technologies, LLC [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated 10/27/2011
05/19/2011 Family Fresh Pack, LLC [ARCHIVED] Minneapolis District Office Seafood HACCP 10/24/2011
05/19/2011 Reed's Inc [ARCHIVED] Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated/Misbranded 12/11/2012
05/19/2011 Prostar, Inc. [ARCHIVED] New England District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated 12/18/2013
05/18/2011 Innolatex SDN. BHD. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Devices/Adulterated 01/11/2012
05/18/2011 Reese Pharmaceutical Company [ARCHIVED] Cincinnati District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
05/18/2011 Dick Van Dam Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
05/18/2011 Natural Choice Distribution Company [ARCHIVED] San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated/Misbranded 08/02/2013
05/17/2011 Medrad Inc [ARCHIVED] Center for Devices and Radiological Health Devices/Reports of Corrections and Removals/Misbranded Not Issued *
05/17/2011 Schneider's Fish & Seafood Corp. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/17/2011 Culpeper Farmers' Cooperative, Inc. [ARCHIVED] Baltimore District Office CGMP for Medicated Feeds/Adulterated 02/12/2013
05/16/2011 www.cheapcigarettesworld.com [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products 10/20/2011
05/16/2011 Malton International LTD [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
05/16/2011 Best Products Solution Limited [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
05/16/2011 Allen Winner [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
05/16/2011 Aubrey Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
05/16/2011 cigarettes-online.biz [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
05/16/2011 Janis Larsen [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
05/16/2011 General Project [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
05/16/2011 AZCigs.com [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
05/16/2011 cigarettesforless.com [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
05/16/2011 Manolo and Son, LLC [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated 10/26/2011
05/16/2011 Contes Pasta Company, Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/CGMP for Food/Adulterated 01/06/2012
05/16/2011 Church & Dwight Inc [ARCHIVED] New Jersey District Office Medical Device Reporting/Misbranded 06/27/2012
05/16/2011 duty-free-cigs.com [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products 08/25/2011
05/16/2011 Anatolli Larionov [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
05/16/2011 Pinsuwan Thanida [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
05/13/2011 Hsu S Ginseng Enterprises [ARCHIVED] Minneapolis District Office CGMP for Dietary Supplements/Adulterated 02/06/2012
05/13/2011 Country Maid, Inc. [ARCHIVED] Minneapolis District Office CGMP for Foods/Seafood HACCP 04/12/2013
05/13/2011 Import Food Wholesale [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Food/Adulterated 08/14/2012
05/13/2011 Nuvonyx, Inc. [ARCHIVED] Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
05/12/2011 Wisconsin Aluminum Foundry Co [ARCHIVED] Minneapolis District Office CGMP for Medical Devices/QS/Adulterated 07/06/2012
05/12/2011 Hugh A Byron [ARCHIVED] Cincinnati District Office Illegal Drug Residue 12/13/2011
05/12/2011 Roman J. Bem [ARCHIVED] Philadelphia District Office Illegal Drug Residue 10/26/2011
05/12/2011 Dawn's Foods, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated 03/18/2014

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