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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
December 05, 2001 BioScience Technologies, Inc. Los Angeles District Office GMP Requirements for Quality System Regulation/Dental Products/Adulterated N/A *
December 05, 2001 Catawba Radiological Associates, Inc. Atlanta District Office Mammography Quality Standards N/A *
December 05, 2001 Chu Minh Tofu, Inc. Seattle District Office Food Labeling/Misbranded N/A *
December 04, 2001 Holder, Walter D., M.D. Center for Biologics Evaluation and Research Sponsor/Clinical Investigator N/A *
December 04, 2001 Eary, Janet, M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
December 03, 2001 Scan Select, Inc. Seattle District Office Seafood HACCP/Adulterated N/A *
December 03, 2001 Pal Do World Seattle District Office Seafood HACCP N/A *
November 30, 2001 OSSTEM Implant Co., Ltd. Center for Devices and Radiological Health Quality System Regulations/Adulterated N/A *
November 29, 2001 American Histolabs, Inc. Center for Drug Evaluation and Research GLP Regulations N/A *
November 29, 2001 Sam Jin Trading Company Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP N/A *
November 29, 2001 Monterey Fish Co., Inc. San Francisco District Office Seafood HACCP/Adulterated N/A *
November 29, 2001 Vasca, Inc. New England District Office Quality System Regulation/Device Labeling/Adulterated/Misbranded N/A *
November 28, 2001 N. Parascandolo & Sons, Inc. New England District Office Seafood HACCP N/A *
November 28, 2001 Jean's Greens New York District Office Forticel Products/New Drug/Labeling/Misbranded N/A *
November 27, 2001 Aurora Medical Group Minneapolis District Office Mammography Quality Standards N/A *
November 27, 2001 Joseph A. Houck Farm Baltimore District Office Drug Residue Edible Animal Tissue/Adulterated N/A *
November 27, 2001 Custom Manufacturing Corporation Florida District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
November 27, 2001 Monterey Fish Co., Inc. San Francisco District Office Seafood HACCP/Adulterated N/A *
November 26, 2001 Presbyterian Hospital of Kaufman Dallas District Office Mammography Quality Standards N/A *
November 26, 2001 Advanced Medical Imaging Dallas District Office Mammography Quality Standards N/A *



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ICECI Warning Letters

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