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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 17, 2009 Stat Medical Devices, Inc. Florida District Office CGMP/QSR/Adulterated/Misbranded N/A *
April 17, 2009 St. Jude Medical Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 14, 2009 Amrex-Zetron, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 14, 2009 Qingdao Jiulong Biopharmaceuticals Co. Ltd. Center for Drug Evaluation and Research CGMP Requirements in the Manufacturing of Drugs/Adulterated N/A *
April 14, 2009 Baxter Healthcare Corp Center for Biologics Evaluation and Research Labeling/False & Misleading Claims/Misbranded N/A *
April 14, 2009 Coast Institutional Review Board Center for Drug Evaluation and Research Institutional Review Board (IRB) N/A *
April 14, 2009 Viral Defender Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
April 14, 2009 Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd. Center for Drug Evaluation and Research CGMP Requirements in the Manufacturing of Drugs/Adulterated N/A *
April 10, 2009 Time-Cap Labs New York District Office CGMP Manufacture, Processing, Packing or Holding/Adulterated N/A *
April 10, 2009 Puretone Ltd. Center for Devices and Radiological Health CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation N/A *
April 09, 2009 IDev Technologies, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 09, 2009 Bruce Branitz, M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
April 09, 2009 M. Slavin & Sons 4/9/09 New York District Office Seafood HACCP/Adulterated N/A *
April 03, 2009 Cuba Tropical Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
April 03, 2009 Amsino Medical USA New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 02, 2009 Dorado Health, Inc. San Juan District Office CGMP for Blood & Blood Components/Adulterated N/A *
March 30, 2009 Lehigh Valley Technologies Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Lannett Company Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Lannett Company, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Cargill Flavor Systems Puerto Rico Inc. San Juan District Office Juice HACCP/Adulterated N/A *



 

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ICECI Warning Letters

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