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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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Tobacco Retailer 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 13, 2004 MacKnight Smoked Foods, Inc. Los Angeles District Office Seafood HACCP/Adulterated N/A *
February 12, 2004 Marine Polymer Technologies, Inc. Center for Devices and Radiological Health Lacks Premarket Approval/Adulterated N/A *
February 12, 2004 Sullivan, J Ralph Dallas District Office Animals for Sale for Slaughter as Food/Adulterated N/A *
February 11, 2004 Osteomed, LP Dallas District Office Quality System Regulation for Medical Devices/Adulterated N/A *
February 11, 2004 S & H Dairy San Francisco District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
February 11, 2004 Harvey Kliebert Plant New Orleans District Office Seafood HACCP/Adulterated N/A *
February 10, 2004 Shanghai Medical Ltd Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredients/Adulterated N/A *
February 09, 2004 Superior Cattle Feeders LLC Los Angeles District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
February 09, 2004 Phillips Cattle Company Los Angeles District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
February 05, 2004 Home Sushi Bar Seattle District Office Seafood HACCP/Adulterated N/A *
February 05, 2004 Gel-Med International Center for Devices and Radiological Health QSR/Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
February 05, 2004 Ehrlich, Randall V., M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
February 04, 2004 Grindstone Neck of Maine, LLC New England District Office Seafood HACCP/Adulterated N/A *
February 04, 2004 Mortillaro Lobster Company, LLC New England District Office Seafood HACCP/Adulterated N/A *
February 04, 2004 Lombardi's Seafood Inc. Florida District Office Seafood HACCP/Adulterated N/A *
February 04, 2004 Domel Laboratories San Juan District Office Promotional Claims/False & Misleading N/A *
February 04, 2004 Domel Laboratories San Juan District Office OTC Drug Labeling/New Drug/Misbranded N/A *
February 04, 2004 Lagler Dairy Seattle District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
February 04, 2004 Rel's Foods Inc. San Francisco District Office Seafood HACCP/Adulterated N/A *
February 04, 2004 Greenwell Farms Cincinnati District Office GMP in Manufacturing, Packing, Holding Food/Adulterated N/A *



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ICECI Warning Letters

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Food and Drug Administration

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Rockville, MD 20857
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