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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

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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 21, 2010 Corepharma LLC [ARCHIVED] New Jersey District Office Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals May 03, 2013
June 21, 2010 Alphatec Spine, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded September 28, 2011
June 21, 2010 Cranial Solutions [ARCHIVED] New Jersey District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation June 05, 2012
June 21, 2010 Lamberts Inc [ARCHIVED] New Orleans District Office Good Manufacturing Practices for Food/Adulterated/Insanitary Conditions Not Issued *
June 21, 2010 Beckman Coulter Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded February 03, 2014
June 21, 2010 Coldstream Farms L.L.C. [ARCHIVED] Seattle District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
June 18, 2010 BENEV Company Inc [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated April 23, 2013
June 17, 2010 Cti Science Inc [ARCHIVED] Cincinnati District Office Dietary Supplement/Labeling False and Misleading/Misbranded March 13, 2012
June 17, 2010 Hostetler, Atlee W. [ARCHIVED] Cincinnati District Office Illegal Drug Residue November 29, 2011
June 16, 2010 Cruz Perez Hermanos S.A. [ARCHIVED] Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated November 04, 2010
June 16, 2010 Oxford Falls [ARCHIVED] New Orleans District Office Food Labeling/Misbranded June 27, 2012
June 15, 2010 Union Development Frozen Foods Co., Ltd [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated/Misbranded Not Issued *
June 15, 2010 Skogen, John L. [ARCHIVED] Minneapolis District Office Illegal Drug Residue November 15, 2010
June 14, 2010 Catalina Offshore Products, Inc [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated March 14, 2011
June 11, 2010 Optovue Inc. [ARCHIVED] San Francisco District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded February 23, 2012
June 10, 2010 Libido Edge Labs, Llc [ARCHIVED] Cincinnati District Office Unapproved New Drug Promotional Claims/Misbranded Not Issued *
June 10, 2010 Medefil Incorporated [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated April 18, 2013
June 10, 2010 Nicola Pizza Inc. [ARCHIVED] Philadelphia District Office CGMP for Foods/Labeling/Misbranded October 04, 2012
June 10, 2010 Clearview Farms [ARCHIVED] Cincinnati District Office Illegal Drug Residue Not Issued *
June 09, 2010 Adamis Pharmaceuticals [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded February 15, 2011



 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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