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U.S. Department of Health and Human Services

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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
June 15, 2004 Barclay Seafoods & Meat Corporation [ARCHIVED] Seattle District Office Seafood HACCP N/A *
June 15, 2004 Massachusetts Institute of Technology [ARCHIVED] Center for Devices and Radiological Health Good Laboratory Practices N/A *
June 15, 2004 Pharma Fab [ARCHIVED] Dallas District Office GMP for Finished Pharmaceuticals/Adulterated N/A *
June 15, 2004 Specialty Brands, Inc. [ARCHIVED] Dallas District Office Animal Proteins Prohibited in Ruminant Feed N/A *
June 15, 2004 Walgreen Company [ARCHIVED] Chicago District Office Insanitary Conditions/Adulterated/Animal Protein Prohibited in Ruminant Feed Not Labeled N/A *
June 14, 2004 Apptec Laboratory Services, Inc. [ARCHIVED] Minneapolis District Office Human Tissue Intended for Transplantation N/A *
June 14, 2004 Stewart's Dairy [ARCHIVED] New York District Office Illegal Drug Residue in Edible Tissue/Extralabel Drug Use/Adulterated N/A *
June 14, 2004 Lumenis, Inc. [ARCHIVED] Denver District Office GMP Requirements for the Quality System Regulation/Adulterated N/A *
June 14, 2004 Engelhard, Peter A., D.O. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
June 10, 2004 Reynolds, John C. [ARCHIVED] New England District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
June 10, 2004 Chapman Ranch [ARCHIVED] Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated N/A *
June 10, 2004 B & G Seed Company [ARCHIVED] Atlanta District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded N/A *
June 08, 2004 International Brachytherapy Inc [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 07, 2004 Spectrum Chemicals & Laboratory Products [ARCHIVED] New Jersey District Office New Drug/Misbranded N/A *
June 07, 2004 Peoples Pharmacy, Inc. [ARCHIVED] Dallas District Office New Drug/Misbranded N/A *
June 07, 2004 Drugs Are Us, Inc. [ARCHIVED] New Jersey District Office New Drug/Misbranded N/A *
June 07, 2004 Axium Healthcare Pharmacy [ARCHIVED] Florida District Office New Drug/Misbranded N/A *
June 04, 2004 Devine Farms, LLC [ARCHIVED] New York District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
June 04, 2004 Biotronik, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor Obligations N/A *
June 04, 2004 Million Air Monterey [ARCHIVED] San Francisco District Office Interstate Conveyance Sanitation Regulations N/A *



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ICECI Warning Letters

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