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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
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 *
January 23, 2008 Diagnostic Health Center of Texas, L.P. [ARCHIVED] Dallas District Office Mammography Quality Standards Act N/A *
January 22, 2008 Glen Willow Orchards [ARCHIVED] Philadelphia District Office Juice HACCP N/A *
January 18, 2008 Omron Healthcare, Inc. [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
January 18, 2008 OLMA-XXI Inc [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
January 18, 2008 Replidyne, Inc. [ARCHIVED] Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
January 17, 2008 Lyne Laboratories, Inc. [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
January 16, 2008 Old Carolina Farms [ARCHIVED] Baltimore District Office Illegal Drug Residue N/A *
January 15, 2008 Piedmont Dairy [ARCHIVED] Atlanta District Office Illegal Drug Residue N/A *
January 15, 2008 Hill-Rom, Inc. [ARCHIVED] Detroit District Office CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded N/A *
January 14, 2008 McLaren Regional Medical Center Institutional Review Board [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board N/A *
January 14, 2008 Tomita Pharmaceutical Co., Ltd [ARCHIVED] Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredients/Adulterated N/A *
January 14, 2008 Baxa Corporation [ARCHIVED] Denver District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 14, 2008 Bellevue Pharmacy Solution [ARCHIVED] Kansas City District Office Promotional Claims False & Misleading/Misbranded N/A *
January 11, 2008 Papas Dairy, LLC [ARCHIVED] New York District Office Illegal Drug Residue N/A *
January 10, 2008 American Hormones, Inc. [ARCHIVED] New York District Office New Drug/Adulterated/Misbranded N/A *
January 09, 2008 Land Ice and Fish Limited [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated N/A *



 

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ICECI Warning Letters

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