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 25, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
April 20, 2010	Milky Way Farm	Atlanta District Office	PHS Act Violation	Not Issued *
April 20, 2010	Capricorn Pharma, Inc.	Baltimore District Office	CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated	March 16, 2011
April 20, 2010	Rainbow Acres Farm	Philadelphia District Office	PHS Act Violation	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 Laser	Center for Devices and Radiological Health	Medical Device Reporting/Misbranded	July 29, 2011
April 15, 2010	Lactasoy Company Limited	Center for Food Safety and Applied Nutrition	Low Acid Canned Food Regulation/Adulterated	Not Issued *
April 15, 2010	Wayne State University IRB	Center for Devices and Radiological Health	Institutional Review Board (IRB)	Not Issued *
April 14, 2010	Lapp, John	Philadelphia District Office	Illegal Drug Residue	Not Issued *
April 13, 2010	Templeton Feed & Grain Inc.	Los Angeles District Office	CGMP for Medicated Feeds/Adulterated	Not Issued *

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