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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

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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

Posted on August 31, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 09, 2010 Village Green Foods, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated January 10, 2012
August 09, 2010 SNBL USA LTD. Center for Drug Evaluation and Research GLP for non-clincal laboratory studies Not Issued *
August 05, 2010 BioVeda Florida District Office Premarket Approval/Misbranded/Adulterated February 10, 2011
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 05, 2010 Madama Oliva Srl Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated/Misbranded September 14, 2010
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 Cosmed Labs, Inc. Cincinnati District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
August 03, 2010 Pioneer Surgical Technology Center for Devices and Radiological Health Sponsor/Clinical Investigator July 17, 2012


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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