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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2009 Warning Letters

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Warning Letters issued in 2009

 

* 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
November 16, 2009 Xanos Holdings Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Akyuz, Sinan Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 onlinepharmacyy.com@proxy.dreamhost.com Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Ric Deleon Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 13, 2009 Accentia Biopharmaceuticals, Inc Florida District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Zyber Pharmaceuticals, Inc New Orleans District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Victory Pharma Inc Los Angeles District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Wraser Pharmaceuticals New Orleans District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Everett Laboratories, Inc New Jersey District Office Lacks Approved New Drug Application/Adulterated January 24, 2011
November 13, 2009 Tiber Laboratories Atlanta District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Allegis Pharmaceuticals, LLC New Orleans District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Cornerstone BioPharma, Inc. Atlanta District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Cornerstone Therapeutics Inc. Atlanta District Office Labeling/Promotional Claims False & Misleading/Misbranded Not Issued *
November 13, 2009 Tyson Foods, Inc Dallas District Office Seafood HACCP Not Issued *
November 13, 2009 Larken Laboratories New Orleans District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 12, 2009 Maine Harvest Seafood New York District Office Seafood HACCP April 14, 2011
November 12, 2009 CFS Operating Limited dba Clouds Food Service Inc Dallas District Office Seafood HACCP September 24, 2010
November 10, 2009 Genetics & IVF Institute Center for Devices and Radiological Health Clinical Investigator (Sponsor) November 19, 2010
November 10, 2009 Arnold Tuber Industries Dba Sci-Dent, Inc New York District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded July 25, 2011
November 10, 2009 Teneo IRB Center for Biologics Evaluation and Research Bioresearch Monitoring Program/IRB Not Issued *



 

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ICECI Warning Letters

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