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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 10, 2008 Innovations for Access, Inc., dba HemoBand Inc. [ARCHIVED] Seattle District Office Premarket Approval/Misbranded/Adulterated N/A *
March 06, 2008 Whittier, Frederick M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 04, 2008 NeumaLife [ARCHIVED] Kansas City District Office New Drug/False Misleading/Labeling/Misbranded N/A *
March 04, 2008 IMULUX, LLC [ARCHIVED] Dallas District Office New Drug/False Misleading/Labeling/Misbranded N/A *
March 04, 2008 Health-science-report.com [ARCHIVED] Seattle District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded N/A *
March 04, 2008 McKinnon, Blair [ARCHIVED] Center for Drug Evaluation and Research New Drug/False Misleading/Labeling/Misbranded N/A *
March 04, 2008 Saferex Laboratories International Corporation [ARCHIVED] Dallas District Office New Drug/False Misleading/Labeling/Misbranded N/A *
March 03, 2008 Kwonnie Electrical Products Limited [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
March 03, 2008 Kwonnie Electrical Products Limited [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 03, 2008 Aidance Skincare & Topical Solutions, LLC [ARCHIVED] New England District Office Drug Labeling/Promotional Claims/Misbranded N/A *
March 03, 2008 Taste Operating, Inc. [ARCHIVED] San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
March 03, 2008 Aviralex Int. [ARCHIVED] San Francisco District Office Drug Labeling/Promotional Claims/Misbranded N/A *
March 03, 2008 Midland Pharmaceutical LLC [ARCHIVED] Kansas City District Office CGMP for Finished Pharmaceutical/Adulterated N/A *
February 29, 2008 Johnson Dairy [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
February 29, 2008 Philips Lifeline, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
February 26, 2008 Paskewitz, Barry J. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
February 25, 2008 West Jefferson Medical Center IRB [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) N/A *
February 25, 2008 Herbal Hope, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition New Drug/Labeling/False & Misleading Claims N/A *
February 21, 2008 InnoMed Technologies, Inc. and RespCare, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 20, 2008 Cochlear Bone Anchored Solutions AB [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
February 20, 2008 Isotron Ireland, Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP for Medical Devices/Adulterated N/A *
February 19, 2008 SyntheMed Inc [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
February 15, 2008 Wilmington Cold Storage, Inc. [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
February 14, 2008 Blue Ribbon Meats Inc [ARCHIVED] Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
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 Clinical Investigator - Human Trials 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 Sherman Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
February 01, 2008 Vintage Pharmaceuticals, LLC [ARCHIVED] New Orleans District Office CGMP/Adulterated N/A *
January 31, 2008 Gulla, Jennifer [ARCHIVED] Los Angeles District Office Street Drugs Alternative N/A *
January 31, 2008 GyNova LLC [ARCHIVED] New England District Office CGMP/Quality System/Adulterated N/A *
January 30, 2008 A-Solutions, Inc. [ARCHIVED] Cincinnati District Office CGMP for Medical Devices/QS/Adulterated 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 Katzen, Barry M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials 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 Hamlin Valley Farms, Inc. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
January 29, 2008 Mendoza Food Products, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
January 28, 2008 Kollef, Marin H., MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
January 28, 2008 Siemens Medical Solutions USA, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 28, 2008 Mabel's Taste of Home, Inc. [ARCHIVED] Minneapolis District Office Acidified Foods/Adulterated N/A *
January 25, 2008 Clasen Quality Coatings, Inc. [ARCHIVED] Minneapolis District Office CGMP Deviations N/A *
January 25, 2008 Nature's Way Products, Inc. [ARCHIVED] Denver District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded N/A *
January 24, 2008 Alfa International Seafood, Inc. & Gamma Seafood Corporation [ARCHIVED] Florida District Office Seafood HACCP N/A *
January 24, 2008 Novartis Vaccines and Diagnostics [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations N/A *
January 24, 2008 Medical Action Industries [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
January 23, 2008 Adams, Mark M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *

 

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