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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
April 22, 2009 Dabur Oncology PLC [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Adulterated N/A *
April 22, 2009 Borkholder Farms [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *
April 21, 2009 Marina Medical Instruments Inc. [ARCHIVED] Florida District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
April 20, 2009 Hernandez, Francisco M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
April 17, 2009 Stat Medical Devices, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Adulterated/Misbranded N/A *
April 17, 2009 St. Jude Medical [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 14, 2009 Coast Institutional Review Board [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) N/A *
April 14, 2009 Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP Requirements in the Manufacturing of Drugs/Adulterated N/A *
April 14, 2009 Amrex-Zetron, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 14, 2009 Qingdao Jiulong Biopharmaceuticals Co. Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP Requirements in the Manufacturing of Drugs/Adulterated N/A *
April 14, 2009 Baxter Healthcare Corp [ARCHIVED] Center for Biologics Evaluation and Research Labeling/False & Misleading Claims/Misbranded N/A *
April 10, 2009 Puretone Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation N/A *
April 10, 2009 Time-Cap Labs [ARCHIVED] New York District Office CGMP Manufacture, Processing, Packing or Holding/Adulterated N/A *
April 09, 2009 M. Slavin & Sons 4/9/09 [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
April 09, 2009 IDev Technologies, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 09, 2009 Branitz, Bruce, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
April 03, 2009 Cuba Tropical Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
April 03, 2009 Amsino Medical USA [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 02, 2009 Dorado Health, Inc. [ARCHIVED] San Juan District Office CGMP for Blood & Blood Components/Adulterated N/A *
March 30, 2009 Dragon Waves Frozen Food Factory Co., Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP N/A *
March 30, 2009 Lannett Company Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Boehringer Ingelheim Roxane Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Cargill Flavor Systems Puerto Rico Inc. [ARCHIVED] San Juan District Office Juice HACCP/Adulterated N/A *
March 30, 2009 Roxane Laboratories, Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Lehigh Valley Technologies Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Glenmark Generics Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Lannett Company, Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Bukowski, Ronald M, MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 30, 2009 Mallinckrodt Inc. Pharmaceuticals Group [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Physicians Total Care, Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Xanodyne Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Cody Laboratories, Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 27, 2009 Templeton Dairy LLC [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
March 24, 2009 Dyna-Moo Dairy, LLC [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
March 20, 2009 Safie Specialty Foods Co., Inc [ARCHIVED] Detroit District Office Acidified Foods/Adulterated N/A *
March 20, 2009 Interior Alaska Fish Processor [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
March 20, 2009 Square One Foods [ARCHIVED] Minneapolis District Office Food Labeling Misbranded N/A *
March 19, 2009 W.H.P.M., Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 16, 2009 American Optisurgical Inc [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 16, 2009 American Mammographics Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 13, 2009 Syntec Nutraceuticals, Inc [ARCHIVED] Minneapolis District Office Promotional Claims False & Misleading/New Drugs N/A *
March 13, 2009 Blackstone Medical Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 12, 2009 Provena St. Joseph's Medical Center IRB Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
March 12, 2009 Express Diagnostics Int'l., Inc [ARCHIVED] Minneapolis District Office Premarket Approval/Misbranded/Adulterated N/A *
March 11, 2009 Best Vascular Inc [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
March 11, 2009 Paulson, Daniel M., MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 10, 2009 Brann Farms [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
March 09, 2009 Merlin Labs, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 06, 2009 D M L Venture Enterprises [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
March 03, 2009 Quinones, Manuel J., MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *

 

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