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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
November 24, 2009 Gazda, Thomas M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 24, 2009 U.F. Union International Food Company [ARCHIVED] San Francisco District Office CGMP/Deviations/Adulterated December 16, 2010
November 24, 2009 Buettner, Craig M., MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 23, 2009 Quesnel Livestock [ARCHIVED] New England District Office Illegal Drug Residue Not Issued *
November 20, 2009 Huaiyin Medical Instruments Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 20, 2009 Microsulis Medical Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 20, 2009 Genetics & IVF Institute [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization November 19, 2010
November 20, 2009 Wellspring International, Inc. [ARCHIVED] Minneapolis District Office Unapproved New Drug Not Issued *
November 20, 2009 Pan American Laboratories, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
November 20, 2009 Centra Health Inc Irb [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
November 19, 2009 United Fish Distributors, Inc. [ARCHIVED] Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions March 23, 2011
November 19, 2009 Mason Brothers Co [ARCHIVED] Minneapolis District Office CGMP for Foods/Seafood HACCP/Adulterated July 13, 2011
November 16, 2009 Graham Farms [ARCHIVED] Florida District Office Illegal Drug Residue Not Issued *
November 16, 2009 tvforever [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 BUZZ, LLC [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Krest Holdings, Panama S.A. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Akyuz, Sinan [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Randek l-warez [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 onlinepharmacyy.com@proxy.dreamhost.com [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Ric Deleon [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Xanos Holdings Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Mendez, Dr Antonio [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Chen-Yu Ou [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Med Light Ltd [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 New Horizons LTD [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Lorna Hillier [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Petroff, Andrey [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Chris Walsh, c/o Dynadot Privacy [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Hunter, D [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Akyuz, Sinan [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Orion Star & Associates Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Forrest Media Incorporated [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Eugene Lefter [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 William Wynne [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Pro West Marketing Ltd. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 13, 2009 Cornerstone Therapeutics Inc. [ARCHIVED] Atlanta District Office Labeling/Promotional Claims False & Misleading/Misbranded Not Issued *
November 13, 2009 Larken Laboratories [ARCHIVED] New Orleans District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Accentia Biopharmaceuticals, Inc [ARCHIVED] Florida District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Zyber Pharmaceuticals, Inc [ARCHIVED] New Orleans District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Victory Pharma Inc [ARCHIVED] Los Angeles District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Wraser Pharmaceuticals [ARCHIVED] New Orleans District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Everett Laboratories, Inc [ARCHIVED] New Jersey District Office Lacks Approved New Drug Application/Adulterated January 24, 2011
November 13, 2009 Tyson Foods, Inc [ARCHIVED] Dallas District Office Seafood HACCP Not Issued *
November 13, 2009 Tiber Laboratories [ARCHIVED] Atlanta District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 13, 2009 Allegis Pharmaceuticals, LLC [ARCHIVED] New Orleans District Office Lacks Approved New Drug Application/Adulterated Not Issued *
November 12, 2009 Maine Harvest Seafood [ARCHIVED] New York District Office Seafood HACCP April 14, 2011
November 12, 2009 CFS Operating Limited dba Clouds Food Service Inc [ARCHIVED] Dallas District Office Seafood HACCP September 24, 2010
November 10, 2009 Teneo IRB Center for Biologics Evaluation and Research Institutional Review Board (IRB) Not Issued *
November 10, 2009 Arnold Tuber Industries Dba Sci-Dent, Inc [ARCHIVED] New York District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded July 25, 2011
November 09, 2009 Scotty's, Inc. [ARCHIVED] Detroit District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated May 12, 2011

 

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ICECI Warning Letters

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