Inspections, Compliance, Enforcement, and Criminal Investigations
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
Posted on July 23, 2009
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| 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 05, 2001 | BioScience Technologies, Inc. | Los Angeles District Office | GMP Requirements for Quality System Regulation/Dental Products/Adulterated | 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 | Vasca, Inc. | New England District Office | Quality System Regulation/Device Labeling/Adulterated/Misbranded | 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 | American Histolabs, Inc. | Center for Drug Evaluation and Research | GLP Regulations | N/A * |
| November 28, 2001 | Jean's Greens | New York District Office | Forticel Products/New Drug/Labeling/Misbranded | N/A * |
| November 28, 2001 | N. Parascandolo & Sons, Inc. | New England District Office | Seafood HACCP | N/A * |
| November 27, 2001 | Joseph A. Houck Farm | Baltimore District Office | Drug Residue Edible Animal Tissue/Adulterated | N/A * |
| November 27, 2001 | Monterey Fish Co., Inc. | San Francisco District Office | Seafood HACCP/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 | Aurora Medical Group | Minneapolis District Office | Mammography Quality Standards | N/A * |
| November 26, 2001 | Rose Women's Center at Littleton | Dallas District Office | Mammography Quality Standards | N/A * |
| November 26, 2001 | Louise G. Wallace Hospital-Breech Medical Center | Dallas District Office | Mammography Quality Standards | N/A * |
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