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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
February 04, 2004 Hydropure Systems Inc Florida District Office QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated N/A *
February 03, 2004 Chestertown Animal Hospital Baltimore District Office Illegal Drug Residue, Animal Tissue/Extra Label Drug Use N/A *
February 03, 2004 Zuka Trading and Distribution Company San Francisco District Office Seafood HACCP/Adulterated N/A *
February 02, 2004 Almil Nutritional Products, Inc. Los Angeles District Office GMP Mfr, Processing, Packing, Holding Drugs/GMP for Finished Pharmaceuticals/Adulterated/Misbranded N/A *
February 02, 2004 Amros the Second, Inc. New Jersey District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
February 01, 2004 Refflex Technologies, Inc. Florida District Office Quality System Regulation/Adulterated/Misbranded N/A *
January 30, 2004 S & F Enterprises Baltimore District Office GMP in Manufacturing, Packing, Holding Food/Adulterated N/A *
January 30, 2004 World Health Products, LLC New England District Office Unapproved New Drug/Misbranded N/A *
January 30, 2004 Better Than Formula, Inc. Detroit District Office Infant Formula/Misbranded N/A *
January 30, 2004 Makevale Limited Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded N/A *
January 29, 2004 Omron Healthcare, Inc. Chicago District Office Quality System Regulation/Adulterated N/A *
January 28, 2004 Larry Peterson Dairy San Francisco District Office Illegal Drug Residue Animal Tissue/Adulterated N/A *
January 28, 2004 Imaging Diagnostic Systems, Inc Center for Devices and Radiological Health Sponsor Obligations N/A *
January 27, 2004 Respironics California Inc. Los Angeles District Office Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded N/A *
January 27, 2004 H.S. Seafood Inc. Los Angeles District Office Seafood HACCP/Adulterated N/A *
January 26, 2004 Nunes Family Dairy, LLC Seattle District Office Illegal Drug Residue Animal Tissue/Adulterated N/A *
January 26, 2004 Rocky Mountain Lions Eye Bank Denver District Office Human Tissue Intended for Transplantation N/A *
January 26, 2004 Cnossen Dairy Seattle District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
January 26, 2004 Cha-Liz Farm LLC New York District Office Illegal Drug Residue, Animal Tissue/Adulterated/Extra Label Drug Use N/A *
January 23, 2004 Waterfront Seafood Company, Inc. New Orleans District Office Seafood HACCP/Adulterated N/A *



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ICECI Warning Letters

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Food and Drug Administration

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