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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
January 13, 2010 Gold Star Seafood, Inc. Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated December 14, 2010
January 13, 2010 C & S Wholesale Grocers, Inc New England District Office Seafood HACCP/CGMP for Foods/Adulterated March 24, 2010
January 13, 2010 K & S Wholesale Meat, Inc. Minneapolis District Office Seafood HACCP October 22, 2012
January 13, 2010 Royer Animal Health, LLC Baltimore District Office Unapproved New Animal Drug/Adulterated/Misbranded/Lack Registration Not Issued *
January 13, 2010 Innovative Beverage Groups Holdings, Inc Dallas District Office Labeling/Adulterated Not Issued *
January 13, 2010 Crystal Cove Seafood / Pt. Panca Mitra Multiperdana Center for Food Safety and Applied Nutrition Seafood HACCP Not Issued *
January 11, 2010 Munroe Regional Medical Centre Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded Not Issued *
January 11, 2010 Holistic Healing Devices Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
January 08, 2010 Centaur, Inc. Kansas City District Office CGMP/Finished Pharmaceuticals/Adulterated May 09, 2011
January 07, 2010 Cerebral Health, Llc Florida District Office Labeling/False & Misleading Claims/New Drug Not Issued *
January 06, 2010 Girard Spring Water Co., Inc. New England District Office Processing and Bottling of Bottled Drinking Water/Adulterated December 07, 2010
January 06, 2010 Providence Hospital Institutional Review Board Center for Devices and Radiological Health Clinical Investigator Not Issued *
January 05, 2010 Ewin Soft and Trade SRL Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
January 05, 2010 CloveCigarettesShop.com Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
January 05, 2010 Ascential Experience Online Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
January 05, 2010 Mountain Health Line Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
January 05, 2010 Apothecary Products, Inc. Detroit District Office Premarket Approval/Misbranded/Adulterated Not Issued *
January 05, 2010 CloveCigarettesMart.com Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
January 05, 2010 MyCloveCigarettes.com Center for Tobacco Products Tobacco Products/Adulterated/Misbranded 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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