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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
09/08/2010 E-CigaretteDirect, LLC [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
09/08/2010 CeraSys, Incorporated [ARCHIVED] Los Angeles District Office Medical Device Reporting (MDR) Regulation Misbranded/Adulterated Not Issued *
09/08/2010 Gamucci [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
09/07/2010 Quinault Indian Nation [ARCHIVED] Seattle District Office CGMP for Foods/Adulterated Not Issued *
09/07/2010 Hard-E Foods Inc [ARCHIVED] Kansas City District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
09/03/2010 Sutures India Pvy. Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 05/10/2013
09/03/2010 Intec Industries Inc [ARCHIVED] New Orleans District Office Device/Adulterated Not Issued *
09/02/2010 Quong Hop & Co [ARCHIVED] San Francisco District Office CGMP for Foods/HACCP/Adulterated Not Issued *
09/01/2010 Fairfield Gourmet Food Corp [ARCHIVED] Center for Food Safety and Applied Nutrition Nutrition Labeling of Food/Misbranded Not Issued *
09/01/2010 Cortechs Labs Inc [ARCHIVED] Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 07/18/2011
09/01/2010 Frontier Medical Products [ARCHIVED] Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 03/29/2013
08/31/2010 iVu Imaging Corporation [ARCHIVED] Dallas District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation 09/19/2011
08/30/2010 Unlimited Nutrition [ARCHIVED] Atlanta District Office Dietary Supplement/Labeling/Misbranded Not Issued *
08/30/2010 Bristol Myers Squibb Holdings Pharma., Ltd. [ARCHIVED] San Juan District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 06/07/2011
08/30/2010 Dr Pepper Snapple Group [ARCHIVED] Center for Food Safety and Applied Nutrition False & Misleading Claims/Misbranded Not Issued *
08/30/2010 Reddick Dairy Philadelphia District Office Illegal Drug Residue Not Issued *
08/27/2010 Matthew N. Songer, MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials Not Issued *
08/25/2010 Sun Pharmaceutical Industries Inc [ARCHIVED] New Jersey District Office CGMP for Finished Pharmaceuticals/Adulterated 09/13/2011
08/25/2010 Flagship Niagara League Inc. [ARCHIVED] Philadelphia District Office PHS Act/Violation 07/12/2011
08/25/2010 Activa Brand Products, Inc. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
08/25/2010 Specialty Brands of America [ARCHIVED] Center for Food Safety and Applied Nutrition Federal Food, Drug and Cosmetic Act/Misbranded Not Issued *
08/24/2010 Storz Medical, AG [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
08/24/2010 18th Street Deli, Inc [ARCHIVED] Detroit District Office Seafood HACCP Not Issued *
08/23/2010 Sallamander Concepts CC Pty Ltd [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
08/23/2010 IriSys, Inc. [ARCHIVED] Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded 09/24/2012
08/23/2010 INZ Distributors Inc. / Magic Power Coffee Inc. [ARCHIVED] New York District Office Unapproved New Drug/Misbranded Not Issued *
08/23/2010 Stericon Pharma Pvt. Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
08/23/2010 Unilever United States, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Promotional Claims False & Misleading/New Drug/Misbranded 05/10/2011
08/20/2010 The Standing Company [ARCHIVED] Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
08/20/2010 Teco Diagnostics [ARCHIVED] Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 10/21/2013
08/19/2010 Depuy Orthopaedics, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded 04/19/2012
08/19/2010 Peslasa S.A. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated 11/30/2010
08/19/2010 Healex Products Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
08/19/2010 B & A Health Products Inc [ARCHIVED] Los Angeles District Office Labeling/OTC Drugs/Misbranded Not Issued *
08/18/2010 MN Airlines LLC dba Sun Country Airlines [ARCHIVED] Los Angeles District Office Interstate Conveyance Sanitation Regulations Not Issued *
08/17/2010 Ken Corscadden New York District Office Illegal Drug Residue Not Issued *
08/17/2010 AMRI Burlington, Inc. (formerly Hyaluron, Inc.) [ARCHIVED] New England District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated 10/30/2013
08/16/2010 R&P Seafood Corp. [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
08/16/2010 Herman A. Jenkins, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials 03/21/2011
08/13/2010 Amish Wedding Foods Inc [ARCHIVED] Cincinnati District Office Low Acid Canned Food Regulation/Adulterated 03/14/2011
08/13/2010 Above Sea Level [ARCHIVED] Denver District Office Seafood HACCP/Insanitary Conditions/Adulterated 08/05/2011
08/13/2010 Inaudi Commerciale Srl [ARCHIVED] Center for Food Safety and Applied Nutrition Deviations From Low Acid Canned Food Regulation/Adulterated Not Issued *
08/13/2010 Juice Pac Inc [ARCHIVED] Cincinnati District Office Juice/HACCP/Adulterated Not Issued *
08/13/2010 A G Specialty Foods, Inc [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
08/12/2010 Summer Infant, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval Application Not Issued *
08/11/2010 Emprede S.A. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP 11/30/2010
08/11/2010 Shun Fung International Trading Inc. [ARCHIVED] San Francisco District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
08/11/2010 Maquet Cardiovascular, LLC [ARCHIVED] New Jersey District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
08/10/2010 Starion Instruments [ARCHIVED] San Francisco District Office Device/Adulterated 06/01/2011
08/09/2010 SNBL USA LTD. [ARCHIVED] Center for Drug Evaluation and Research Good Laboratory Practice (GLP) 11/08/2012

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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