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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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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
September 10, 2001 Fujiya Sushi Concepts, Inc. Dallas District Office Seafood HACCP N/A *
September 10, 2001 Delta Imports, Inc. Chicago District Office Import/Lacks "May Proceed Notice" or "Release Notice" N/A *
September 07, 2001 Total Medical Inofrmation Management Systems, Inc. Florida District Office QSR for Medical Devices/Picture Archiving & Communication Systems Software/Adulterated N/A *
September 07, 2001 Eastern Carolina Internal Medicine, P.A. Atlanta District Office Mammography Quality Standards N/A *
September 07, 2001 Hallmark Sales Corporation Dallas District Office CGMP Requirements of the Quality System Regulations/First Aid Kits & Sterile Kits/Adulterated N/A *
September 07, 2001 MacKnight Smoked Food Inc. New York District Office Frozen Mackerel Fillets/Lacks "May Proceed" or "Release Notice" N/A *
September 07, 2001 Parreiro-Pinheiro & Sons Dairy San Francisco District Office Illegal Drug Tissue Residue/Adulterated N/A *
September 07, 2001 MacKnight Smoked Food Inc. New York District Office Frozen Mackerel Fillets/Lacks "May Proceed" or "Release Notice" N/A *
September 07, 2001 Pharmakon Labs, Inc. Florida District Office CGMP/Lack Approved New Drug Application/Adulterated/Misbranded N/A *
September 07, 2001 Burlington Imaging & Breast Center PA Atlanta District Office Mammography Quality Standards N/A *
September 07, 2001 Parreiro-Pinheiro & Sons Dairy San Francisco District Office Illegal Drug Tissue Residue/Adulterated N/A *
September 06, 2001 Regional West Medical Center-Mobile Dallas District Office Mammography Quality Standards N/A *
September 06, 2001 Classic Charter, Inc. San Francisco District Office Control of Communicable Diseases and Interstate Conveyance Sanitation N/A *
September 06, 2001 Sera-Tec Biologicals Limited Partnership Cincinnati District Office Current Good Manufacturing Practices for Blood and Blood Components N/A *
September 06, 2001 Sierra Kings District Hospital San Francisco District Office Mammography Quality Standards N/A *
September 06, 2001 Regional West Medical Center Dallas District Office Mammography Quality Standards N/A *
September 06, 2001 Presbyterian Hospital of Greenville Dallas District Office Mammography Quality Standards N/A *
September 06, 2001 Memorial Hospital of Sweetwater County Dallas District Office Mammography Quality Standards N/A *
September 06, 2001 Classic Charter, Inc. San Francisco District Office Control of Communicable Diseases and Interstate Conveyance Sanitation N/A *
September 06, 2001 Mary Chiles Hospital Cincinnati District Office Mammography Quality Standards N/A *



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ICECI Warning Letters

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