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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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
August 31, 2004 Terumo Cardiovascular Systems Corp. [ARCHIVED] Detroit District Office CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated N/A *
August 31, 2004 G.T. Laboratories [ARCHIVED] Chicago District Office Quality System Regulation/Adulterated N/A *
August 31, 2004 Midwest Heart Foundation [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board N/A *
August 30, 2004 Henrico Doctor's Hospital IRB Center for Devices and Radiological Health Institutional Review Board N/A *
August 30, 2004 Medical Device Resource Corporation [ARCHIVED] San Francisco District Office GMP for Medical Devices/QSR/Adulterated N/A *
August 30, 2004 Ly, David S. [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
August 27, 2004 Remington Medical Inc [ARCHIVED] Atlanta District Office QSR/Medical Devices/Adulterated N/A *
August 27, 2004 Washington Township Hospital [ARCHIVED] San Francisco District Office Mammography Quality Standards N/A *
August 27, 2004 Center for Comprehensive Medicine [ARCHIVED] San Francisco District Office Mammography Quality Standards N/A *
August 26, 2004 Flora, Inc. [ARCHIVED] Seattle District Office Unapproved New Drug/Misbranded N/A *
August 26, 2004 American Fruit Distributors, Inc. [ARCHIVED] New England District Office Refusal to Permit Entry/Inspection N/A *
August 25, 2004 Two Brothers Organics, Inc. [ARCHIVED] Denver District Office Juice HACCP/Adulterated N/A *
August 25, 2004 Guaranteed Total Vending [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
August 25, 2004 La Vencedora Products, Inc. [ARCHIVED] Los Angeles District Office Food Labeling/Misbranded N/A *
August 24, 2004 ICH Group, LLC dba Sushi Chef [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
August 23, 2004 Medical Industries America, Inc. [ARCHIVED] Kansas City District Office CGMP Requirements of the Quality System Regulations/Adulterated N/A *
August 20, 2004 Medical Energy, Inc. [ARCHIVED] Florida District Office Quality System Regulation for Medical Devices/Adulterated N/A *
August 19, 2004 Window Rock Enterprises, Inc. [ARCHIVED] Los Angeles District Office Promotional Claims/False & Misleading/Misbranded N/A *
August 19, 2004 Poseidon Seafood, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP N/A *
August 18, 2004 Natureplex, LLC [ARCHIVED] New Orleans District Office Current Good Mfg Practice Regulation/Adulterated/Misbranded N/A *



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ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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