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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2003 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters issued in 2003

 

* 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
April 18, 2003 Cardinal Medical Specialties Inc Cincinnati District Office Quality System Regulation/Medical Device Reporting/Adulterated N/A *
April 16, 2003 Lakeview Farms Minneapolis District Office Illegal Edible Tissue Residue/Adulterated N/A *
April 15, 2003 Pulmonetic Systems Inc Minneapolis District Office Quality System Reguation/Adulterated N/A *
April 15, 2003 Nuovo Pasta Productions, Ltd. New England District Office Seafood HACCP N/A *
April 15, 2003 Alejandro Romandia Toyos Dallas District Office Salmonella Adulteration/Circumvention of Import Alert N/A *
April 15, 2003 Prime Dental Manufacturing, Inc. Chicago District Office Quality System Regulation/Medical Device Reporting/Adulterated N/A *
April 14, 2003 Halton, Jacqueline M., M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
April 14, 2003 Baptist Women's Pavilion Hospital New Orleans District Office Mammography Quality Standards N/A *
April 14, 2003 Box Canyon Dairy Seattle District Office Illegal Drug Residue/Edible Tissue/Adulterated N/A *
April 14, 2003 Vision Chips Inc Los Angeles District Office Quality System Reguation/Adulterated N/A *
April 14, 2003 North Texas IRB Center for Biologics Evaluation and Research Institutional Review Board N/A *
April 11, 2003 Riemer MediTech GmbH Center for Devices and Radiological Health CGMP for Medical Devices/QS/Adulterated N/A *
April 11, 2003 Huntsville Hospital Center for Devices and Radiological Health IRB (Institutional Review Board) N/A *
April 10, 2003 Milford Seafood Corporation New England District Office Seafood HACCP/Adulterated N/A *
April 09, 2003 Designs for Vision Inc New York District Office Quality System Reguation/Adulterated N/A *
April 09, 2003 Rio Vista Veterinary Hospital New York District Office Illegal Edible Tissue Residue/Adulterated N/A *
April 09, 2003 Selfworx.Com LLC New England District Office New Drug N/A *
April 08, 2003 Wolf, Douglas C., M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
April 08, 2003 OSIM (USA) Inc Los Angeles District Office New Drug/Misbranded N/A *
April 08, 2003 Marcel and Henri Select Meats Inc San Francisco District Office Seafood HACCP/Adulterated N/A *



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ICECI Warning Letters

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