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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

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

Warning Letters issued in 2010

 

* 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
August 13, 2010 Above Sea Level Denver District Office Seafood HACCP/Insanitary Conditions/Adulterated August 05, 2011
August 13, 2010 Inaudi Commerciale Srl Center for Food Safety and Applied Nutrition Deviations From Low Acid Canned Food Regulation/Adulterated Not Issued *
August 13, 2010 Juice Pac Inc Cincinnati District Office Juice/HACCP/Adulterated Not Issued *
August 13, 2010 A G Specialty Foods, Inc Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
August 12, 2010 Summer Infant, Inc. Center for Devices and Radiological Health Premarket Approval Application Not Issued *
August 11, 2010 Emprede S.A. Center for Food Safety and Applied Nutrition Seafood HACCP November 30, 2010
August 11, 2010 Shun Fung International Trading Inc. San Francisco District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
August 11, 2010 Maquet Cardiovascular, LLC New Jersey District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
August 10, 2010 Starion Instruments San Francisco District Office Device/Adulterated June 01, 2011
August 09, 2010 SNBL USA LTD. Center for Drug Evaluation and Research GLP for non-clincal laboratory studies November 08, 2012
August 09, 2010 Village Green Foods, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated January 10, 2012
August 09, 2010 Diasol Inc Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 05, 2010 BioVeda Florida District Office Premarket Approval/Misbranded/Adulterated February 10, 2011
August 05, 2010 Madama Oliva Srl Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated/Misbranded September 14, 2010
August 05, 2010 FACTORIA DEL LAGO C.A. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
August 05, 2010 Johnson Sea Products, Inc New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
August 04, 2010 Sunic's Food, Inc. d.b.a Sun Food Trading Company Seattle District Office Seafood HACCP/Adulterated Not Issued *
August 04, 2010 Neoventa Medical AB Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 03, 2010 Baxter International Inc. Center for Biologics Evaluation and Research Misleading Efficacy Claim June 23, 2011
August 03, 2010 Corporacion Del Mar Center for Food Safety and Applied Nutrition Seafood HAACP/CGMP for Foods/Adulterated Not Issued *



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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