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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

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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

Posted on March 02, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 17, 2010 King Cone International Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 16, 2010 Songkla Canning Public Company Limited Center for Food Safety and Applied Nutrition Seafood HACCP Not Issued *
February 16, 2010 La Mexicana, Inc. Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions Not Issued *
February 16, 2010 Nature'S Gift Inc Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus Not Issued *
February 16, 2010 Biological Controls New Jersey District Office CGMP/QSR/Adulterated/Misbranded June 15, 2011
February 16, 2010 Gourmet Express Marketing, Inc. Chicago District Office Seafood HACCP/CGMP/Misbranded Not Issued *
February 16, 2010 Crestview Calves, Inc. Seattle District Office Illegal Drug Residue Not Issued *
February 12, 2010 LASIK Vision Institute LLC Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
February 12, 2010 Wu, Helen K. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded July 29, 2011
February 12, 2010 Huyard, Christian M. Philadelphia District Office Illegal Drug Residue Not Issued *


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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