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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

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Warning Letters issued in 2010

 

* 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 22, 2010 Dreyer's Ice Cream Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Diamond Food Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Redco Foods, Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 First Juice Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Sunsweet Growers Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Gerber Products Co Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Ken's Foods, Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Pompeian, Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Gorton's, Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Spectrum Organic Products, Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded February 10, 2011
February 22, 2010 Pbm Products, LLC Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Fleminger Inc Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 18, 2010 Stardust Dairy, LLC Cincinnati District Office Illegal Drug Residue May 30, 2012
February 18, 2010 Vertical Pharmaceuticals, Inc. New Jersey District Office Premarket Approval/Misbranded/Adulterated March 08, 2011
February 18, 2010 Lucky Farm Inc Seattle District Office Adulterated Not Issued *
February 17, 2010 Brennan And Mccoy Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Health, Wealth, & Happiness Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Unisource, Inc. Denver District Office Unapproved New Drug/Misbranded Not Issued *
February 17, 2010 Amasha Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Herbs, Heirlooms and Homebrew Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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