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U.S. Department of Health and Human Services

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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
November 08, 2001 Kimball Foods, Inc. [ARCHIVED] Chicago District Office Seafood HACCP N/A *
November 08, 2001 Iso-Tex Diagnostics, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
November 08, 2001 Far Ocean Sea Products Pte., Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP N/A *
November 08, 2001 Quality Crab Company, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP N/A *
November 07, 2001 Community Radiology, P.A. [ARCHIVED] New Jersey District Office Mammography Quality Standards N/A *
November 07, 2001 Fair Oaks Hospital Medical Plaza [ARCHIVED] Baltimore District Office Mammography Quality Standards N/A *
November 07, 2001 Sea-Lect Wholesale Seafood Inc. [ARCHIVED] New Jersey District Office Seafood HACCP N/A *
November 07, 2001 Sea-Lect Wholesale Seafood Inc. New Jersey District Office Seafood HACCP N/A *
November 07, 2001 Community Radiology, P.A. New Jersey District Office Mammography Quality Standards N/A *
November 07, 2001 Aventura Diagnostic Center [ARCHIVED] Florida District Office Mammography Quality Standards N/A *
November 06, 2001 Eye Centers of Florida [ARCHIVED] Florida District Office Human Tissue Intended for Transportation N/A *
November 05, 2001 Saint Dominic's Hospital [ARCHIVED] San Francisco District Office Mammography Quality Standards N/A *
November 05, 2001 Miller II, Damon P., M.D. [ARCHIVED] Center for Devices and Radiological Health Labeling/Lacks Premarket Notification N/A *
November 05, 2001 Diomed Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Notification/Misbranded/Adulterated N/A *
November 05, 2001 ARJO, Ltd. [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation/Adulterated N/A *
November 05, 2001 Westchester-Bronx OB/Gyn Group, P.C. [ARCHIVED] Buffalo District Office Mammography Quality Standards N/A *
November 05, 2001 Borgess- Pipp Health Center [ARCHIVED] Detroit District Office Mammography Quality Standards N/A *
November 05, 2001 Art's Trading Company [ARCHIVED] San Francisco District Office Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated N/A *
November 02, 2001 Baxter Healthcare Corporation [ARCHIVED] Chicago District Office Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals N/A *
November 01, 2001 Gorman, John F., M.D. [ARCHIVED] Buffalo District Office Mammography Quality Standards N/A *



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ICECI Warning Letters

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Food and Drug Administration

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