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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 30, 2010 Darr Feedlot Inc Kansas City District Office CGMP for Medicated Feeds/Adulterated Not Issued *
April 29, 2010 Vision Pharm, LLC Florida District Office Lacks Approved New Drug Application/Adulterated/Misbranded Not Issued *
April 29, 2010 Olsen Fish Company Minneapolis District Office Seafood HACCP/Adulterated November 15, 2010
April 29, 2010 U Okada & Co Ltd San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
April 29, 2010 Malda, Jeff New York District Office Illegal Drug Residue Not Issued *
April 29, 2010 Noxubee County Producers Inc. (dba Superior Fish Products) New Orleans District Office CGMP for Foods/Seafood HACCP/Adulterated August 19, 2010
April 29, 2010 L. Perrigo Company Detroit District Office CGMP for Finished Pharmaceuticals/Adulterated May 09, 2011
April 28, 2010 Corner View Dairies New York District Office Illegal Drug Residue Not Issued *
April 27, 2010 Martin Feed Lot Chicago District Office Illegal Drug Residue September 14, 2011
April 26, 2010 Ephraim McDowell Regional Medical Center IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
April 26, 2010 La Estrellita Enterprises Incorporated Denver District Office Acidified Foods/Adulterated Not Issued *
April 26, 2010 Accurate Set Inc. New Jersey District Office CGMP/QSR/Adulterated/Misbranded 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 23, 2010 Elma Dairy, LLC Seattle District Office Illegal Drug Residue 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 Care Holdings, Inc dba The LASIK Vision Institute Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
April 20, 2010 Vision Care Holdings, LLC Center for Devices and Radiological Health Medical Device Reporting/Misbranded February 18, 2011
April 20, 2010 TLC Vision Corporation Center for Devices and Radiological Health Medical Device Reporting/Misbranded February 18, 2011
April 20, 2010 Lasik Plus Vision Center Center for Devices and Radiological Health Medical Device Reporting/Misbranded July 29, 2011



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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