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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2008 Warning Letters

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Warning Letters issued in 2008

 

* 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 April 08, 2009

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 12, 2008 Mallinckrodt Inc., dba Covidien Kansas City District Office CGMP/Deviations/Adulterated N/A *
August 12, 2008 Sandoz Inc. Atlanta District Office CGMP/Deviations/Adulterated N/A *
August 11, 2008 Hart Dairy II Dallas District Office Illegal Drug Residue N/A *
August 11, 2008 Valley Baptist Medical Center IRB Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
August 08, 2008 Allez Spine, LLC Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 08, 2008 DavisMade, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
August 08, 2008 Lifesoy, Inc. Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
August 08, 2008 Walter's Seafood, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 07, 2008 Sunetics International Corporation Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded N/A *
August 07, 2008 Gaunitz Hair Sciences, LLC Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded N/A *
August 06, 2008 O'Ryan Industries, Inc. Seattle District Office Device Lacks Marketing Clearance Approval/Adulterated/Misbranded N/A *
August 06, 2008 Center Oriental Food Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 06, 2008 Bruno's of Duluth, Inc. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 06, 2008 Cascadia Manufacturing, Inc. Seattle District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated N/A *
August 05, 2008 Pacific American Fish Co. Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 01, 2008 Mavidon Medical Products Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 29, 2008 LifeGuard Health LLC Center for Food Safety and Applied Nutrition Promotional Claims False & Misleading/New Drugs N/A *
July 29, 2008 NeoChild LLC Dallas District Office CGMP for Medical Devices/QS/Adulterated N/A *
July 24, 2008 G & W Laboratories, Inc. CGMP for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
July 23, 2008 Husain, Mustafa M, M.D. Center for Devices and Radiological Health Clinical Investigator N/A *


 

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ICECI Warning Letters

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Food and Drug Administration

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