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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
July 26, 2004 Kioschos, Hans C., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
July 26, 2004 Tenacore Holdings, Inc. [ARCHIVED] Los Angeles District Office Good Manufacturing Practice for Medical Devices Regulation/Quality System/Adulterated N/A *
July 26, 2004 Toledo, Jose Gregorio [ARCHIVED] San Juan District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
July 26, 2004 Sierra Dairy [ARCHIVED] Dallas District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
July 26, 2004 Double J Livestock [ARCHIVED] Baltimore District Office Sale for Slaughter as Food/Adulterated N/A *
July 23, 2004 DANA Diabecare USA LLC [ARCHIVED] New Orleans District Office Medical Device Reporting/Misbranded N/A *
July 22, 2004 Ultra-Seal Corporation [ARCHIVED] New York District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
July 22, 2004 Beck Farms, LP [ARCHIVED] New York District Office Illegal Drug Residue Animal Tissue/Extra-Label Drug Use/Adulterated N/A *
July 22, 2004 Brotherhood Farms [ARCHIVED] New York District Office Illegal Drug Residue, Animal Tissue/Adulterated/Extra Label Drug Use N/A *
July 21, 2004 Modesto Fish Company [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
July 21, 2004 Chios Bakery, Inc. [ARCHIVED] Baltimore District Office CGMP/Deviations/Adulterated N/A *
July 21, 2004 Lextron Texas LLP [ARCHIVED] Dallas District Office Extralabel Drug Use in Animals/Adulterated N/A *
July 20, 2004 Love and Quiches, Ltd. [ARCHIVED] New York District Office Interstate Conveyance Sanitation/GMP Mfr, Packing, Holding Food N/A *
July 20, 2004 Hidden Valley Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
July 19, 2004 OST Medical, Inc. [ARCHIVED] New England District Office Lacks Premarket Approval/Adulterated/Misbranded N/A *
July 19, 2004 Nutraceutical International Corporation [ARCHIVED] Denver District Office Food/Adulterated N/A *
July 19, 2004 Amstutz, Harlan C., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
July 19, 2004 Marquez, Raul A., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
July 16, 2004 The Gourmet Padre [ARCHIVED] Atlanta District Office Food Labeling Misbranded N/A *
July 16, 2004 Stonington Sea Products, Inc. [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *



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ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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