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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
December 31, 2009 Penumbra, Inc. San Francisco District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded September 21, 2010
December 29, 2009 Crothall Healthcare, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded July 29, 2011
December 28, 2009 Branan Medical Corp. Inc. Los Angeles District Office Premarket Approval/Misbranded/Adulterated May 17, 2012
December 24, 2009 Micro Current Technology, Inc. Seattle District Office Device Lacks Marketing Clearance Approval/Adulterated/Misbranded Not Issued *
December 23, 2009 Arteriocyte Medical Systems Inc Center for Biologics Evaluation and Research Device/Lacks Approved Premarket Application/Adulterated/Misbranded February 17, 2010
December 23, 2009 Genetics & IVF Institute IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
December 23, 2009 Grupo Alimentario Del Atlantico Sa "Gralco Sa" Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 22, 2009 Balchem Corporation Chicago District Office Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals August 18, 2010
December 21, 2009 Victus, Inc. Florida District Office Medical Device/CGMP Requirements of Quality System Regulation October 07, 2010
December 21, 2009 Paul W. Marks Co., Inc New England District Office Seafood HACCP/CGMP for Foods/Adulterated April 29, 2010
December 21, 2009 Ohm Laboratories, Inc. New York District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
December 17, 2009 Florida Atlantic University IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
December 16, 2009 Sushi On a Roll, Inc Los Angeles District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
December 15, 2009 Awesome Foods, Inc. Philadelphia District Office Food Labeling/Misbranded April 30, 2010
December 15, 2009 Micromed Technology, Inc Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
December 15, 2009 Sibley Memorial Hospital Baltimore District Office CGMP for Blood & Blood Products/Adulterated Not Issued *
December 14, 2009 Millenkamp Cattle Seattle District Office Illegal Drug Residue Not Issued *
December 14, 2009 Burgos Burgos Corp. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated June 08, 2011
December 14, 2009 Indonesia Clove Cigarettes Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
December 14, 2009 Langit Bali Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *



 

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ICECI Warning Letters

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