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 31, 2001 | Matthews, Dana C., M.D. | Center for Biologics Evaluation and Research | Sponsor/Clinical Investigator | N/A * |
| December 28, 2001 | Green Gold Wholesale Produce Inc. | Baltimore District Office | Avocados/Lacks | N/A * |
| December 28, 2001 | Hen-Lin Dairy | Minneapolis District Office | Animal Drug/Adulterated | N/A * |
| December 28, 2001 | Trotters Importers | Baltimore District Office | Dried Fig Spread/Lacks | N/A * |
| December 27, 2001 | N TECH Instrument Repair, Inc. | Chicago District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
| December 27, 2001 | 2-2-0 Laboratories | Los Angeles District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
| December 27, 2001 | Premium Fresh Juice and Food Company, Inc. | Los Angeles District Office | GMP in Manufacturing, Packing, Holding Human Food/Insanitary Practices | N/A * |
| December 27, 2001 | B.N.S Uni, Inc. | Los Angeles District Office | Seafood HACCP | N/A * |
| December 27, 2001 | Island Kinetics Inc | Los Angeles District Office | CGMP for Finished Pharmaceutical/Adulterated | N/A * |
| December 21, 2001 | Feldman Mark H. D.P.M. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
| December 21, 2001 | Forever Young Products, Inc. | New Orleans District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | N/A * |
| December 21, 2001 | West Agro, Inc. | Chicago District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
| December 20, 2001 | Medical Center at Lancaster | Dallas District Office | Mammography Quality Standards | N/A * |
| December 20, 2001 | Norton Suburban Hospital | Cincinnati District Office | Mammography Quality Standards | N/A * |
| December 20, 2001 | Misonix, Inc. | Denver District Office | GMP Requirements for the Quality System Regulation/Adulterated | N/A * |
| December 20, 2001 | Van de Graaf Racnhes, Inc. | Seattle District Office | Current Good Manufacturing Practice for Medicated Feeds/Adulterated | N/A * |
| December 20, 2001 | Carolina Seafood Ventures, LLC | Atlanta District Office | Seafood HACCP | N/A * |
| December 20, 2001 | NCOIC | Dallas District Office | Mammography Quality Standards | N/A * |
| December 20, 2001 | Breast Cancer Detection Center of Alaska | Seattle District Office | Mammography Quality Standards | N/A * |
| December 20, 2001 | Luskin-Hawk, M.D., Roberta L | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
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