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 May 04, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
April 26, 2010 | Ephraim McDowell Regional Medical Center IRB | Center for Drug Evaluation and Research | Institutional Review Board (IRB) | Not Issued * |
April 26, 2010 | Accurate Set Inc. | New Jersey District Office | CGMP/QSR/Adulterated/Misbranded | Not Issued * |
April 23, 2010 | Elma Dairy, LLC | Seattle District Office | Illegal Drug Residue | Not Issued * |
April 23, 2010 | St. Jude Medical Atrial Fibrillation Division Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (Sponsor)/Promoting Unapproved Use/Misbranded/Adulterated | Not Issued * |
April 22, 2010 | Brookwood Medical Center | Center for Drug Evaluation and Research | Institutional Review Board (IRB) | Not Issued * |
April 21, 2010 | Land Dairy, Inc. | Florida District Office | Illegal Drug Residue | Not Issued * |
April 20, 2010 | Uv Flu Technologies, Inc. | Center for Devices and Radiological Health | Unapproved/Uncleared/Unauthorized Products Related to the 2009 H1N1 Flu Virus | Not Issued * |
April 20, 2010 | Lasik Plus Vision Center | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | July 29, 2011 |
April 20, 2010 | Care Holdings, Inc dba The LASIK Vision Institute | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | Not Issued * |
April 20, 2010 | Lasik Vision Institute (Boca Raton, FL) | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
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