Inspections, Compliance, Enforcement, and Criminal Investigations
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2010 Warning Letters
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Warning Letters issued in 2010
* 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 March 20, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
March 11, 2010 | Toledo, Charles H., M.D. | Center for Biologics Evaluation and Research | Bioresearch Monitoring Program/IRB | April 06, 2010 |
March 11, 2010 | Talisman Limited | Baltimore District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
March 10, 2010 | NY Fish, Inc. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
March 10, 2010 | Clearwater Products, LLC | Florida District Office | Medical Devices/Adulterated/Misbranded | Not Issued * |
March 08, 2010 | Double B Dairy, LLC | Seattle District Office | Illegal Drug Residue | Not Issued * |
March 08, 2010 | Frischs Commissary | Cincinnati District Office | Seafood HACCP/CGMP for Foods/Adulterated | |
March 08, 2010 | Lin, Henry, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
March 05, 2010 | Otologics LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (Sponsor) | Not Issued * |
March 04, 2010 | Sun Technologies, Inc. | Center for Devices and Radiological Health | Tanning Facility/Federal Performance Standard for Sunlamp Products/Misbranded | Not Issued * |
March 02, 2010 | Perez-Cruet, Miguelangelo J., M.D., M.S. | Center for Devices and Radiological Health | Investigational Device Exemptions (Clinical Investigator) | Not Issued * |
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