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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
May 25, 2004 Color Change Corporation [ARCHIVED] Chicago District Office GMP for Medical Devices/QSR/Medical Device Reporting Procedures/Adulterated N/A *
May 25, 2004 Sullivan Harbor Farm, Inc. [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
May 25, 2004 Baxter Healthcare Corporation [ARCHIVED] Center for Biologics Evaluation and Research Promotional Claims/Misbranded N/A *
May 21, 2004 Scientific Botanicals Co., Inc. [ARCHIVED] Seattle District Office Dietary Supplement Regulations/Misbranded N/A *
May 20, 2004 Nelsons Premix Service, Inc. [ARCHIVED] Kansas City District Office New Animal Drugs/Misbranded N/A *
May 19, 2004 Perry Dewey Farm [ARCHIVED] New York District Office Illegal Drug Residue /Adulterated N/A *
May 19, 2004 Menu Foods, Inc. [ARCHIVED] New Jersey District Office Animal Proteins Prohibited in Ruminant Feed N/A *
May 19, 2004 Healthy World Distributing [ARCHIVED] Seattle District Office New Drugs, Unapproved/Labeling/Misbranded N/A *
May 19, 2004 New Day Fisheries, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
May 19, 2004 San Diego Soy Dairy [ARCHIVED] Los Angeles District Office Good Manufacturing Practice Regulations for Human Foods/Adulterated N/A *
May 19, 2004 M & M Barcelos Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
May 19, 2004 Sunsweet Growers, Inc. [ARCHIVED] San Francisco District Office Labeling/Misbranded N/A *
May 18, 2004 Custom Industrial Analysis Laboratories, Inc. [ARCHIVED] Kansas City District Office Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated N/A *
May 17, 2004 TBA Mexican Trade Grocery [ARCHIVED] Dallas District Office Import/Product Substitution/Adulterated/Misbranded N/A *
May 17, 2004 Haemoscope Corporation [ARCHIVED] Chicago District Office Quality System Regulation/Adulterated N/A *
May 17, 2004 Tallmon Dairy [ARCHIVED] Denver District Office Illegal Drug Residue/Adulterated N/A *
May 17, 2004 Celsion Corporation [ARCHIVED] Center for Devices and Radiological Health Sponsor Obligations N/A *
May 14, 2004 Wright Medical Technology, Inc. [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions N/A *
May 14, 2004 Dillman, Robert O., M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
May 13, 2004 Shoemaker, Ritchie C., M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator 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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