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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
January 28, 2010 Nasr, Samya, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
January 28, 2010 Xian Libang Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Manufacturing Facility/Active Pharmaceutical Ingredient July 07, 2011
January 27, 2010 OST Medical, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated July 11, 2012
January 27, 2010 Kellogg USA Atlanta District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions August 15, 2012
January 26, 2010 Fertility and Reproductive Medicine Center for Women Florida District Office Human Cells, Tissues & Cellular Products September 29, 2010
January 26, 2010 www.ayurvediccure.com Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
January 25, 2010 Venus Foods Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 25, 2010 Meyer Food Service LLC dba Empire Fish Co Minneapolis District Office Seafood HACCP/Adulterated Not Issued *
January 22, 2010 Medisound Inc Florida District Office Mammography Quality Standards Act Not Issued *
January 22, 2010 Cardiovascular Diagnostic Image, Inc. Florida District Office Mammography Quality Standards Act Not Issued *
January 19, 2010 Sun Hang Bean Sprout Inc Detroit District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions Not Issued *
January 19, 2010 Cayman Chemical Company Center for Drug Evaluation and Research Clinical Investigator (Sponsor) Not Issued *
January 19, 2010 SweetSommer Water Bottling Company, LLC. Baltimore District Office Processing and Bottling of Bottled Drinking Water/Adulterated Not Issued *
January 19, 2010 Crown Health Care Laundry Services, Inc. New Orleans District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation Not Issued *
January 15, 2010 Baxter Biosciences Center for Biologics Evaluation and Research CGMP Deviations March 22, 2010
January 15, 2010 Cybernet Systems Corp. Detroit District Office CGMP/QS/Adulterated/Misbranded April 15, 2011
January 15, 2010 McNeil Consumer and Specialty Pharmaceuticals San Juan District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated Not Issued *
January 14, 2010 Sunrise Pharmaceutical, Inc. New Jersey District Office CGMP for Finished Pharmaceuticals/Adulterated/Mi sbranded December 20, 2011
January 14, 2010 Premium Dental, LLC New Jersey District Office CGMP/QSR/Medical Devices/Adulterated February 04, 2011
January 14, 2010 Boonesboro Animal Clinic Corporation Cincinnati District Office Illegal Drug Residue December 06, 2011



 

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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