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U.S. Department of Health and Human Services

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 *


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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