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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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2004 Warning Letters

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Warning Letters issued in 2004

 

* 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 02, 2004 Chambermaid Products, Inc. Florida District Office QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated N/A *
March 02, 2004 Per-Tech, Inc. Minneapolis District Office QSR/Adulterated/Undeclared Ingredient/Misbranded N/A *
March 01, 2004 MedRx, Inc. Florida District Office QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated N/A *
February 27, 2004 Pharmpak, Inc. San Francisco District Office GMP for Finished Pharmaceuticals/Drug Repackaging/Adulterated N/A *
February 26, 2004 Epicenter Dairy Denver District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
February 26, 2004 DynaMedics Corporation Center for Devices and Radiological Health Quality System Regulation/Adulterated N/A *
February 25, 2004 Maple Dairy San Francisco District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
February 25, 2004 Premier Medical Philadelphia District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
February 25, 2004 Fay's Foods, Inc. Los Angeles District Office GMP in Manufacturing, Packing, Holding Human Food/Adulterated N/A *
February 24, 2004 Obsidian Medical Technology Inc. San Francisco District Office Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated N/A *
February 24, 2004 Sea Win, Inc. Los Angeles District Office Seafood HACCP/Adulterated N/A *
February 24, 2004 Quintana Hermanos Inc. San Juan District Office Seafood HACCP/Adulterated N/A *
February 24, 2004 TMJ Implants, Inc. Denver District Office Medical Device Reporting Regulation/Misbranded N/A *
February 20, 2004 United Feeds, Inc. Chicago District Office Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
February 20, 2004 Cardio Display Corporation New York District Office Quality System Regulation for Medical Devices/Adulterated N/A *
February 20, 2004 Gumbo Brothers Inc. New Orleans District Office Seafood HACCP/Adulterated N/A *
February 18, 2004 Global Internet Alliance Dallas District Office Unapproved New Drug/Misbranded N/A *
February 18, 2004 Discount Prescriptions from Canada, Inc. Center for Drug Evaluation and Research Illegal Canadian Drug Importation N/A *
February 17, 2004 Wing Kee Foodstuff Company San Francisco District Office GMP in Manufacturing, Packing, Holding Food/Adulterated N/A *
February 13, 2004 Mid-Atlantic Diagnostics Center for Devices and Radiological Health Lack Approved Premarket Clearance/Adulterated/Misbranded N/A *



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ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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