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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
June 13, 2001 Rich Products Corporation [ARCHIVED] Buffalo District Office Baked Goods/Lacks "May Proceed Notice" or "Release Notice" N/A *
June 13, 2001 Johns Hopkins Breast Imaging [ARCHIVED] Baltimore District Office Mammography Quality Standards N/A *
June 12, 2001 Integral Fish Foods Inc. [ARCHIVED] Denver District Office Animal Proteins Prohibited in Ruminant Feed N/A *
June 12, 2001 Moran Rowen & Dorsey Inc. - Breast Imaging Center [ARCHIVED] Los Angeles District Office Mammography Quality Standards N/A *
June 11, 2001 TheraTest Laboratories Inc [ARCHIVED] Chicago District Office In Vitro Diagnostic Kits/Quality System Regulation for Medical Devices/Adulterated N/A *
June 11, 2001 Telstar Innovations Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Approved Premarket Application/Adulterated/Misbranded N/A *
June 11, 2001 Meridian Bioscience Inc. [ARCHIVED] Cincinnati District Office In-Vitro Diagnostic Products/Quality System Regulation/Adulterated N/A *
June 11, 2001 Walmart Stores [ARCHIVED] Florida District Office Shipment/Lacks"May Proceed Notice" or "Release Notice" N/A *
June 11, 2001 Great Plains Food Company [ARCHIVED] Denver District Office Seafood HACCP/Alligator Products N/A *
June 08, 2001 Greyhound Lines Inc. [ARCHIVED] San Francisco District Office Interstate Conveyance Sanitation N/A *
June 08, 2001 Kaiser Permanente Medical Center [ARCHIVED] Los Angeles District Office Mammography Quality Standards N/A *
June 08, 2001 Aircraft Service International Group [ARCHIVED] San Francisco District Office Interstate Conveyance Sanitation N/A *
June 08, 2001 Biomet Inc. [ARCHIVED] Detroit District Office Disposable Infusion Pump Kit/Qaulity System Regulation/Adulterated N/A *
June 08, 2001 East Los Angeles Doctors Hospital [ARCHIVED] Los Angeles District Office Mammography Quality Standards N/A *
June 08, 2001 WAW Enterprises [ARCHIVED] San Francisco District Office Seafood HACCP/GMP Requirements for Foods N/A *
June 08, 2001 Smucker Quality Beverages Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Food Labeling/Lacks Approved New Drug Application/Misbranded N/A *
June 08, 2001 Kaiser Foundation Hospital-Panorama City [ARCHIVED] Los Angeles District Office Mammography Quality Standards N/A *
June 08, 2001 Mercy Medical Center [ARCHIVED] Minneapolis District Office Mammography Quality Standards N/A *
June 08, 2001 Prosec Security Systems Inc. New Jersey District Office Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated N/A *
June 07, 2001 Pacific Rim Ice & Fish Packing Services Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/GMP Requirements for Foods N/A *



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