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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2011 Warning Letters

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Warning Letters issued in 2011

 

* 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
December 13, 2011 Woeber Mustard Manufacturing Co Inc Cincinnati District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 13, 2011 Kencor Ethnic Foods, Inc Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions July 16, 2012
December 13, 2011 CPR Medical Devices, Inc. Center for Devices and Radiological Health Quality System Regulation/Adulterated Not Issued *
December 12, 2011 1 800 Get Thin LLC Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
December 12, 2011 Lone Star Lions Eye Bank Dallas District Office Human Cells, Tissues & Cellular Products May 25, 2012
December 12, 2011 Gilroy Spice Company San Francisco District Office Acidified Foods/Acid Canned Food Regulation/Misbranded Not Issued *
December 09, 2011 Li Da Seafood Trading Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 09, 2011 CuraeLase, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 09, 2011 Palmdale Ambulatory Surgery Center Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
December 09, 2011 Valencia Ambulatory Surgery Center, LLC Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
December 09, 2011 San Diego Ambulatory Surgery Center, LLC Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
December 09, 2011 Beverly Hills Surgery Center, LLC Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
December 09, 2011 Fuller Family Dairy, LLC New York District Office Illegal Drug Residue Not Issued *
December 09, 2011 Quasar Bio-Tech, Inc. dba Silver Bay LLC Florida District Office Premarket Approval/Misbranded/Adulterated Not Issued *
December 09, 2011 Light-Tech, Inc. Florida District Office Medical Device Reporting/Misbranded Not Issued *
December 09, 2011 J. DeLuca Fish Company, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 09, 2011 Spencer Forrest, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded Not Issued *
December 08, 2011 Gabrimar Export Fish, S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
December 08, 2011 DePuy Orthopaedics, Inc. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated September 27, 2012
December 08, 2011 GF Health Products, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated March 26, 2013



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