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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 26, 2009 King Systems Corp. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
October 26, 2009 Thermography and Breast Health Center of Idaho Center for Devices and Radiological Health Premarket Approval/Adulterated Not Issued *
October 23, 2009 ZaCh System S.A. Center for Drug Evaluation and Research CGMP Manufacture, Processing, Packing or Holding/Adulterated April 12, 2011
October 23, 2009 McKay, Charles M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
October 22, 2009 Endotec, Inc. Florida District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
October 22, 2009 Vander Horst Dairy and Farming Dallas District Office Animal Sale for Slaughter as Food/Adulterated November 12, 2010
October 21, 2009 Minatare Feed Lot Inc Kansas City District Office CGMP for Medicated Feeds/Adulterated Not Issued *
October 19, 2009 MI Hope Inc. dba Center for Complex Infectious Diseases IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
October 16, 2009 Pacific American Fish Co., Inc New England District Office CGMP for Foods/Seafood HACCP/Adulterated March 11, 2010
October 16, 2009 Trilogy Crab Co. Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
October 16, 2009 Schwarz Fish Co. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 13, 2012
October 16, 2009 Okami, Incorporated Denver District Office CGMP for Foods/Seafood HACCP/Adulterated December 01, 2010
October 15, 2009 Weil Lifestyle LLC Center for Biologics Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
October 15, 2009 Cold Cut Kruise, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated May 17, 2011
October 14, 2009 Seaport Fish Company New England District Office Seafood HACCP April 21, 2010
October 14, 2009 J & V Dairy, LLC Seattle District Office Illegal Drug Residue Not Issued *
October 13, 2009 Cerovene, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
October 13, 2009 G3 Medical Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 13, 2009 Dynamic Surgery, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated February 28, 2011
October 13, 2009 DAVA Pharmaceuticals, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded March 22, 2011



 

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ICECI Warning Letters

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