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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
December 06, 2010 Lady-Comp USA Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
December 06, 2010 Valley Electronics GmbH Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
December 06, 2010 Natural Methods, Inc. Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
December 06, 2010 GAR Laboratories Inc Los Angeles District Office CGMP/Finished Products/Adulterated Not Issued *
December 06, 2010 New Wha Ming Trading of MN, Inc Minneapolis District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated July 08, 2011
December 03, 2010 Iso-Tex Diagnostics, Inc Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
December 03, 2010 Hain Celestial Group Denver District Office CGMP For Manufacturing, Packing, or Holding Human Food December 06, 2011
December 02, 2010 PCI Synthesis New England District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated September 29, 2011
December 02, 2010 United Taiwan Corp. - Chao Zhou Plant Center for Food Safety and Applied Nutrition CGMP for Deviations/Adulterated May 19, 2011
December 02, 2010 Prolatis Denver District Office Dietary Supplement/Adulterated Not Issued *
December 02, 2010 LifeNet Health Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
December 02, 2010 Ocean Fresh LLC San Francisco District Office Seafood HACCP November 25, 2011
December 02, 2010 Dong-A Otsuka Co. Ltd. Center for Food Safety and Applied Nutrition Acidified Foods/Adulterated March 25, 2011
December 02, 2010 Herbal-supplements-for-you Center for Food Safety and Applied Nutrition Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded Not Issued *
December 02, 2010 Nutri Herb Inc Florida District Office New Drug/Adulterated/Misbranded Not Issued *
December 01, 2010 Myron J. Diller Farm Philadelphia District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
December 01, 2010 Advanced Surgical Design & Manufacture, Ltd. Center for Devices and Radiological Health CGMP Manufacturer, Processsing, Packing, Holding/Devices/Adulterated Not Issued *
December 01, 2010 Airgas, Inc. New Orleans District Office CGMP for Finished Pharmaceuticals/Adulterated May 18, 2011
November 30, 2010 OsteoSymbionics LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
November 29, 2010 Optilasa SA Center for Devices and Radiological Health CGMP/QSR/Medical Devices/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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