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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
October 16, 2001 Ramco Laboratories, Inc. [ARCHIVED] Dallas District Office CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded N/A *
October 15, 2001 Walton Feeds West, Inc. [ARCHIVED] Denver District Office New Animal Drug/Adulterated N/A *
October 15, 2001 Burnham Laboratories, Inc. [ARCHIVED] Chicago District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
October 15, 2001 Roth International Ltd. [ARCHIVED] Chicago District Office Quality System Regulation for Medical Devices/Adulterated N/A *
October 15, 2001 Neillsville Memorial Medical Center, Inc. [ARCHIVED] Minneapolis District Office Mammography Quality Standards N/A *
October 15, 2001 Winn, Inc. [ARCHIVED] Denver District Office New Animal Drug for Use In Feeds/Lacks FDA Medicated Feed Mill License/Adulterated N/A *
October 15, 2001 Outsourcing Services Group [ARCHIVED] Atlanta District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
October 12, 2001 Fair Scones, Inc. Seattle District Office Food Labeling/Adulterated/Misbranded N/A *
October 12, 2001 Washington County Hospital [ARCHIVED] Dallas District Office Mammography Quality Standards N/A *
October 12, 2001 Northwest Airlines, Inc. [ARCHIVED] Detroit District Office Control of Communicable Disease and Interstate Conveyance Sanitation/Adulterated N/A *
October 12, 2001 American Pharmaceutical Partners, Inc. Chicago District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
October 12, 2001 Welch Road Imaging [ARCHIVED] San Francisco District Office Mammography Quality Standards N/A *
October 12, 2001 Fair Scones, Inc. [ARCHIVED] Seattle District Office Food Labeling/Adulterated/Misbranded N/A *
October 12, 2001 St. Anthony Memorial Health Center [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board N/A *
October 12, 2001 Madeira Beach Seafood Inc [ARCHIVED] Florida District Office Seafood HACCP N/A *
October 12, 2001 Mese Hsin Tung Yang Foods, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP N/A *
October 12, 2001 NDT Pharm Management, LLC [ARCHIVED] Los Angeles District Office New Drug N/A *
October 12, 2001 Luneau S.A. Center for Devices and Radiological Health Quality System Regulations/Medical Device Reporting/Electronic Records/Adulterated N/A *
October 12, 2001 International Biologicals, Inc. [ARCHIVED] Center for Biologics Evaluation and Research GMP for Blood & Blood Components/Records & Reports N/A *
October 12, 2001 Aquavit Inc. [ARCHIVED] New York District Office Seafood HACCP N/A *



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