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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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
March 25, 2008 Xoran Technologies Inc [ARCHIVED] Detroit District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 25, 2008 Ophthalmic Technologies, Inc. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
March 25, 2008 GlaxoSmithKline [ARCHIVED] Atlanta District Office Postmarketing Adverse Drug Experience N/A *
March 21, 2008 CRS Medical Diagnostics, Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 21, 2008 Laser Therapeutics, Inc. [ARCHIVED] New England District Office Premarket Approval/Misbranded/Adulterated N/A *
March 20, 2008 Brar, Saroj M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 20, 2008 Acacia Engineered Products LLC [ARCHIVED] New Orleans District Office CGMP for Medical Devices/Lacks Premarket Approval Application/Adulterated N/A *
March 19, 2008 Retro-Tech, LLC [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
March 19, 2008 Shah, Ashok M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 19, 2008 David C. Hoffman, D.D.S. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
March 17, 2008 GMR Products Inc [ARCHIVED] CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 14, 2008 Pyrenees Dairy [ARCHIVED] Los Angeles District Office Illegal Drug Residue N/A *
March 13, 2008 Hilton Becker, MD [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) N/A *
March 12, 2008 Van Dyk Dairy #1 [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
March 11, 2008 Stewart's Processing Corp. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
March 11, 2008 Coast Institutional Review Board [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) N/A *
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 McKinnon, Blair [ARCHIVED] Center for Drug Evaluation and Research New Drug/False Misleading/Labeling/Misbranded N/A *
March 04, 2008 NeumaLife [ARCHIVED] Kansas City District Office New Drug/False Misleading/Labeling/Misbranded N/A *



 

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