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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2009 Warning Letters

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Warning Letters issued in 2009

 

* 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
October 13, 2009 G3 Medical Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 13, 2009 DAVA Pharmaceuticals, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded March 22, 2011
October 13, 2009 Glenmark Pharmaceuticals Inc. USA 10/13/09 Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
October 13, 2009 Myojo USA, Inc. Los Angeles District Office Acidified Foods/Emergency Permit Control/Adulterated April 03, 2012
October 09, 2009 Philips Healthcare Inc. 10/9/09 New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 09, 2009 Pacific Nutritional Foods, Inc. Seattle District Office Low Acid Canned Food Regulation/Adulterated Not Issued *
October 09, 2009 LCA Vision Inc. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LasikPlus Vision Center Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Evergreen Acres Minneapolis District Office Illegal Drug Residue April 29, 2010
October 09, 2009 LasikPlus Vision Center Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Lasik Plus Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Lasik Vision Institute Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Lasik Vision Institute Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 TLC Laser Eye Center d/b/a TLC Pittsburgh Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 TLC Laser Eye Centers Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LCA Vision, Inc Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 TLC Laser Eye Centers Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Lasik Vision Institute Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LasikPlus Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LasikPlus Vision Center Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *



 

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ICECI Warning Letters

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