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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
March 26, 2010 Pierre Fabre Medicament Production Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated August 17, 2011
March 26, 2010 Liquid Manufacturing, L.L.C. Detroit District Office Acidified Foods/Adulterated January 07, 2011
March 26, 2010 Estrella Food Products, Inc. San Juan District Office Food Labeling/Insanitary Conditions/Adulterated/Misbranded Not Issued *
March 25, 2010 3CPM Company Inc Baltimore District Office CGMP/QSR/Medical Devices/Adulterated December 13, 2010
March 25, 2010 Today's Temptations, Inc. Chicago District Office Food Labeling/Misbranded Not Issued *
March 24, 2010 Roxy Trading Inc Los Angeles District Office Adulterated Food Not Issued *
March 23, 2010 Dornier Medtech America, Inc. Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
March 23, 2010 Simplydelicious Denver District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions January 19, 2011
March 18, 2010 Paragon Dx, LLC Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated May 11, 2010
March 17, 2010 Tinnitus Control, Inc. Center for Devices and Radiological Health Device/Lacks Annual Registration/Misbranded May 10, 2010
March 17, 2010 KHL Inc Center for Devices and Radiological Health Device/Misbranded May 20, 2010
March 17, 2010 Chawla, Sant P., M.D. Center for Drug Evaluation and Research Clinical Investigator July 29, 2014
March 17, 2010 Orthotic & Prosthetic Lab, Inc. Center for Devices and Radiological Health Device/Lacks Annual Registration/Misbranded May 10, 2010
March 17, 2010 Orthotic & Prosthetic Lab Inc. Center for Devices and Radiological Health Device/Misbranded Not Issued *
March 17, 2010 Empire Dairy Denver District Office Illegal Drug Residue Not Issued *
March 17, 2010 Providence Dairy, LLC Detroit District Office Illegal Drug Residue December 08, 2010
March 17, 2010 James P. Johnston, CO, dba Midwest Ocular Prosthetics Center for Devices and Radiological Health Device/Misbranded, Not Issued *
March 17, 2010 Vulcon Technologies Inc Center for Devices and Radiological Health Device/Misbranded Not Issued *
March 17, 2010 Tinnitus Control, Inc. Center for Devices and Radiological Health Device/Misbranded Not Issued *
March 16, 2010 Konec Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded March 16, 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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