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2008 Warning Letters

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Warning Letters issued in 2008

 

* 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
February 13, 2008 Klein, Kevin W., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
February 12, 2008 Michael S. Miller, D.O. [ARCHIVED] Center for Biologics Evaluation and Research Investigational Device Exemptions (Clinical Investigator) N/A *
February 11, 2008 Roes Haven Farm [ARCHIVED] New York District Office Illegal Drug Residue N/A *
February 07, 2008 International Pharmaceutical Corporation [ARCHIVED] Center for Food Safety and Applied Nutrition Drug Labeling/Promotional Claims/Misbranded N/A *
February 06, 2008 Scheenstra Farms Inc [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
February 04, 2008 MedX Corporation [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 01, 2008 Vintage Pharmaceuticals, LLC [ARCHIVED] New Orleans District Office CGMP/Adulterated N/A *
February 01, 2008 Sherman Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
January 31, 2008 GyNova LLC [ARCHIVED] New England District Office CGMP/Quality System/Adulterated N/A *
January 31, 2008 Gulla, Jennifer [ARCHIVED] Los Angeles District Office Street Drugs Alternative N/A *
January 30, 2008 Katzen, Barry M.D. [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) N/A *
January 30, 2008 Animal Magnetism Inc [ARCHIVED] Florida District Office PHS Act/Violation N/A *
January 30, 2008 Teamedics (Taishan) Manufacturing Co., Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
January 30, 2008 A-Solutions, Inc. [ARCHIVED] Cincinnati District Office CGMP for Medical Devices/QS/Adulterated N/A *
January 29, 2008 Vinh Sam Enterprise [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated N/A *
January 29, 2008 Mendoza Food Products, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
January 29, 2008 Hamlin Valley Farms, Inc. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
January 28, 2008 Kollef, Marin H., MD [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) N/A *
January 28, 2008 Mabel's Taste of Home, Inc. [ARCHIVED] Minneapolis District Office Acidified Foods/Adulterated N/A *
January 28, 2008 Siemens Medical Solutions USA, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *



 

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