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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

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005

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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
01/13/2010 Gold Star Seafood, Inc. [ARCHIVED] Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated 12/14/2010
01/13/2010 C & S Wholesale Grocers, Inc [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated 03/24/2010
01/13/2010 K & S Wholesale Meat, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP 10/22/2012
01/13/2010 Royer Animal Health, LLC [ARCHIVED] Baltimore District Office Unapproved New Animal Drug/Adulterated/Misbranded/Lack Registration Not Issued *
01/13/2010 Innovative Beverage Groups Holdings, Inc [ARCHIVED] Dallas District Office Labeling/Adulterated Not Issued *
01/13/2010 Crystal Cove Seafood / Pt. Panca Mitra Multiperdana [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP Not Issued *
01/11/2010 Munroe Regional Medical Centre [ARCHIVED] Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded Not Issued *
01/11/2010 Holistic Healing Devices [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
01/08/2010 Centaur, Inc. [ARCHIVED] Kansas City District Office CGMP/Finished Pharmaceuticals/Adulterated 05/09/2011
01/07/2010 Cerebral Health, Llc [ARCHIVED] Florida District Office Labeling/False & Misleading Claims/New Drug Not Issued *
01/06/2010 Girard Spring Water Co., Inc. [ARCHIVED] New England District Office Processing and Bottling of Bottled Drinking Water/Adulterated 12/07/2010
01/06/2010 Providence Hospital Institutional Review Board [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
01/05/2010 Ewin Soft and Trade SRL [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
01/05/2010 CloveCigarettesShop.com [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
01/05/2010 Ascential Experience Online [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
01/05/2010 Mountain Health Line [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
01/05/2010 Apothecary Products, Inc. [ARCHIVED] Detroit District Office Premarket Approval/Misbranded/Adulterated Not Issued *
01/05/2010 CloveCigarettesMart.com [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
01/05/2010 MyCloveCigarettes.com [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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