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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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
September 29, 2009 Millipore Corporation Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus February 17, 2010
September 29, 2009 Weartech International Inc. Los Angeles District Office CGMP/QSR/Adulterated/Misbranded April 03, 2012
September 28, 2009 Advantage Communications Enterprises Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
September 28, 2009 Drugs Are Us, Inc. Center for Drug Evaluation and Research Active Pharmaceutical Ingredient/Adulterated Not Issued *
September 28, 2009 Zanzibar Cafe, Inc. Los Angeles District Office Seafood HACCP Not Issued *
September 25, 2009 Trans-Caribbean Dairy Corporation 9/25/09 San Juan District Office Juice HACCP/Adulterated Not Issued *
September 23, 2009 Platinum Strategies, Inc. Detroit District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded July 07, 2010
September 23, 2009 Orval Kent Food Company, Inc. Los Angeles District Office Seafood HACCP Not Issued *
September 21, 2009 Mountain Meadow Herbs, Inc Seattle District Office Labeling/New Drug/Misbranded Not Issued *
September 18, 2009 Advanced Medical Optics Uppsala Ab Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated December 20, 2011
September 15, 2009 Kirkwood, John M., MD Center for Biologics Evaluation and Research Clinical Investigator May 28, 2010
September 15, 2009 Kohinoor Foods, Inc. Baltimore District Office CGMP/Manufacturing Packing & Holding Human Food/Misbranded Not Issued *
September 15, 2009 Mu Kung Hwa Oriental Foods, LLC Seattle District Office CGMP Regulation For Food/Adulterated Not Issued *
September 14, 2009 Viraban Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
September 14, 2009 Setton Pistachio of Terra Bella, Inc. San Francisco District Office CGMP/Prepared, Packed, or held under insanitary Conditions/Adulterated Not Issued *
September 14, 2009 SKW Ventures, LLC Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
September 14, 2009 Pyramid Sprouters Minneapolis District Office Adulterated Food June 02, 2011
September 11, 2009 Ocean Hyperbaric Center Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
September 11, 2009 Cumberland Farms, Inc. New England District Office CGMP for Foods/Seafood HACCP/Adulterated February 25, 2010
September 11, 2009 Customed, Inc San Juan District Office CGMP/QSR/Medical Devices/Adulterated September 02, 2010



 

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