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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
February 04, 2011 KJPL Restaurants Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 17, 2011
February 04, 2011 Czimer's Foods, Inc Chicago District Office CGMP/Adulterated/Misbranded Not Issued *
February 04, 2011 Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals Florida District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
February 04, 2011 Limpia Arteria Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded Not Issued *
February 04, 2011 Juice Tyme, Inc. Chicago District Office CGMP for Foods/Juice HACCP/Adulterated September 14, 2011
February 03, 2011 Aid United International Co. Limited Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
February 03, 2011 Coastal Implant Technologies, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated April 27, 2012
February 03, 2011 OEM Systems Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
February 02, 2011 Furman Foods Inc Philadelphia District Office CGMP/Acidified Foods/Adulterated July 26, 2011
February 01, 2011 Tra & Accessories Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
February 01, 2011 Tennessee Scientific, Inc./Scientific Formulations LLC New Orleans District Office New Drug/Adulterated/Misbranded Not Issued *
February 01, 2011 Hite's Livestock, Inc. Baltimore District Office Illegal Drug Residue November 30, 2012
January 31, 2011 Mom's Food Products, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 31, 2011 Teva Pharmaceutical Industries Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated September 09, 2011
January 28, 2011 Sanofi-Aventis U.S. LLC New Jersey District Office Postmarketing Adverse Drug Experience Reporting Requirements July 05, 2011
January 28, 2011 Fresenius Se Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
January 26, 2011 A.G.S. Wholesalers, Inc. Los Angeles District Office CGMP Regulation For Food/Adulterated/Misbranded Not Issued *
January 25, 2011 Medicepts, Inc. Florida District Office Lacks Premarket Approval Application/Adulterated/Misbranded Not Issued *
January 25, 2011 Foremost Foods International, Inc. Los Angeles District Office Seafood HACCP/Adulterated Not Issued *
January 24, 2011 Costumes For Your Eyes Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated February 27, 2012



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