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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 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
August 02, 2010 MP Biomedicals LLC Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded Not Issued *
August 02, 2010 Pescamarca Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
August 02, 2010 Saputo Cheese USA Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
July 30, 2010 Scully, Sean M.D. Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) Not Issued *
July 30, 2010 Vaill Brothers New York District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
July 29, 2010 M.I. Tech Co Ltd Center for Devices and Radiological Health Medical Device Reporting (MDR) Regulation Misbranded/Adulterated Not Issued *
July 29, 2010 HSMG, Inc. D/b/a Smartinfuser USA Dallas District Office Medical Device Reporting Regulation/Misbranded Not Issued *
July 29, 2010 Dutch Valley Farms Denver District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
July 29, 2010 Golden Pacific Foods Inc. Los Angeles District Office Seafood HACCP/Insanitary Conditions/Adulterated/Misbranded Not Issued *
July 28, 2010 Life Recovery Systems HD, LLC Center for Devices and Radiological Health Medical Device/Lacks Premarket Approval/Adulterated/Misbranded October 07, 2010
July 27, 2010 Biomet, Inc. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated February 10, 2011
July 27, 2010 Eaton Manufacturing Corporation Dba Eaton Medical New Orleans District Office Medical Device Reporting/Misbranded Not Issued *
July 27, 2010 Gropoint Seafood Industries Sdn Bhd Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
July 26, 2010 Nitrox, Inc. Seattle District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
July 22, 2010 Boca Pharmacal Inc. Florida District Office Unapproved New Drug/Misbranded Not Issued *
July 22, 2010 Flowers Baking Company of Villa Rica, LLC Atlanta District Office Food Labeling Misbranded Not Issued *
July 21, 2010 Euro Gourmet, Inc. Baltimore District Office Seafood HACCP/Adulterated April 28, 2011
July 21, 2010 Stuart Harlin, Md Center for Devices and Radiological Health Clinical Investigator 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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