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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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2001 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters for 2001

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* 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 16, 2001 Esolyte, Inc. Denver District Office Good Manufacturing Practices for Blood & Blood Components/Adulterated N/A *
July 16, 2001 Icicle Seafoods, Inc. Seattle District Office Seafood HACCP N/A *
July 16, 2001 Simmons Farm Raised Catfish, Inc. New Orleans District Office Seafood HACCP/Frozen Catfish/Adulterated N/A *
July 16, 2001 Georgetown Seafood Co., Inc. Atlanta District Office Seafood HACCP N/A *
July 16, 2001 Wanchese Fish Company, Inc. Atlanta District Office Seafood HACCP N/A *
July 13, 2001 Hawaiian Sun Products, Inc. Los Angeles District Office Food Labeling/Insanitary Conditions/Adulterated/Misbranded N/A *
July 13, 2001 Alliance Medical Corporation Atlanta District Office Quality System Regulation/Adulterated N/A *
July 13, 2001 Prospect Enterprise, Inc. Los Angeles District Office Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated N/A *
July 13, 2001 Aventis Bio-Sciences Seattle District Office Good Manufacturing Practice Regulations for Blood and Blood Components N/A *
July 13, 2001 San Juan Bautista Medical Center San Juan District Office CGMP for Blood & Components/General Biological Products Standards/Adulterated N/A *
July 13, 2001 Adventist Health Walla Walla General Hospital Seattle District Office GMP for Blood & Blood Components/General Biological Standards N/A *
July 13, 2001 Reddy, Duttala Obula, M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
July 13, 2001 Ocean Pride Seafood Los Angeles District Office Seafood HACCP N/A *
July 13, 2001 Biomax Formulations Los Angeles District Office New Drug/Labeling/Misbranded N/A *
July 12, 2001 Scotland Memorial Hospital Atlanta District Office Mammography Quality Standards N/A *
July 12, 2001 Carrollton Farmers Exchange Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed N/A *
July 12, 2001 Tend Skin International, Inc. Florida District Office OTC Drugs/Adulterated/Misbranded N/A *
July 12, 2001 Sunset Deli Seattle District Office Seafood HACCP/Tuna Salad Sandwiches N/A *
July 12, 2001 Newman's Fish Company Seattle District Office Seafood HACCP N/A *
July 12, 2001 Technical Products, Inc. Atlanta District Office Quality System Regulation/Adulterated N/A *



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ICECI Warning Letters

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