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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
07/06/2010 Triple G Dairy Los Angeles District Office Illegal Drug Residue 08/05/2010
07/06/2010 Country Road Veterinary Services LLC [ARCHIVED] Cincinnati District Office New Animal Drug/Adulterated/Labeling/Misbranded 09/01/2010
07/02/2010 Abbott Diabetes Care, Inc. [ARCHIVED] San Francisco District Office CGMP for Medical Devices/QS/Adulterated Not Issued *
07/02/2010 Steril Aire [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
07/02/2010 Replication Medical Inc [ARCHIVED] Center for Devices and Radiological Health Medical Device/Lacks Premarket Approval/Adulterated/Misbranded 11/23/2010
07/02/2010 Regancrest Holsteins, Inc. Kansas City District Office Illegal Drug Residue Not Issued *
06/30/2010 Haldiman, Keith And Patricia Minneapolis District Office Illegal Drug Residue 11/15/2010
06/28/2010 Nemechek Do Pa, Patrick [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator 07/29/2010
06/28/2010 Arasys Perfector Inc [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting (MDR) Regulation Misbranded/Adulterated 01/31/2011
06/28/2010 Hi-Tech Pharmacal Co., Inc. [ARCHIVED] New York District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded 09/05/2011
06/25/2010 American Pecan Co. LLC [ARCHIVED] Dallas District Office CGMP for Foods/Labeling/Adulterated/Misbranded Not Issued *
06/25/2010 Pozner, Jason M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials Not Issued *
06/25/2010 AMPAC Fine Chemicals, LLC [ARCHIVED] San Francisco District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated 04/25/2011
06/24/2010 North Memorial Medical Center [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
06/24/2010 Thumb Oilseed Producers' Cooperative [ARCHIVED] Detroit District Office CGMP Regulation For Food/Adulterated Not Issued *
06/23/2010 Blountys, LLC [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
06/23/2010 Basic Food Flavors, Inc. [ARCHIVED] San Francisco District Office CGMP/Foods/Insanitary Conditions Not Issued *
06/23/2010 Oregon Health & Science University [ARCHIVED] Seattle District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products Not Issued *
06/22/2010 Nanjing Pharmaceutical Factory Company Limited [ARCHIVED] Center for Veterinary Medicine CGMP/Active Pharmaceutical Ingredient Manufacturing Facility/Adulterated Not Issued *
06/22/2010 MedCentral Health System [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
06/21/2010 Corepharma LLC [ARCHIVED] New Jersey District Office Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals 05/03/2013
06/21/2010 Alphatec Spine, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded 09/28/2011
06/21/2010 Cranial Solutions [ARCHIVED] New Jersey District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation 06/05/2012
06/21/2010 Lamberts Inc [ARCHIVED] New Orleans District Office Good Manufacturing Practices for Food/Adulterated/Insanitary Conditions Not Issued *
06/21/2010 Beckman Coulter Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded 02/03/2014
06/21/2010 Coldstream Farms L.L.C. Seattle District Office Illegal Drug Residue Not Issued *
06/18/2010 BENEV Company Inc [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated 04/23/2013
06/17/2010 Cti Science Inc [ARCHIVED] Cincinnati District Office Dietary Supplement/Labeling False and Misleading/Misbranded 03/13/2012
06/17/2010 Hostetler, Atlee W. [ARCHIVED] Cincinnati District Office Illegal Drug Residue 11/29/2011
06/16/2010 Cruz Perez Hermanos S.A. [ARCHIVED] Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated 11/04/2010
06/16/2010 Oxford Falls [ARCHIVED] New Orleans District Office Food Labeling/Misbranded 06/27/2012
06/15/2010 Union Development Frozen Foods Co., Ltd [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated/Misbranded Not Issued *
06/15/2010 Skogen, John L. [ARCHIVED] Minneapolis District Office Illegal Drug Residue 11/15/2010
06/14/2010 Catalina Offshore Products, Inc [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated 03/14/2011
06/11/2010 Optovue Inc. [ARCHIVED] San Francisco District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 02/23/2012
06/10/2010 Libido Edge Labs, Llc [ARCHIVED] Cincinnati District Office Unapproved New Drug Promotional Claims/Misbranded Not Issued *
06/10/2010 Medefil Incorporated [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated 04/18/2013
06/10/2010 Nicola Pizza Inc. [ARCHIVED] Philadelphia District Office CGMP for Foods/Labeling/Misbranded 10/04/2012
06/10/2010 Clearview Farms [ARCHIVED] Cincinnati District Office Illegal Drug Residue Not Issued *
06/09/2010 Adamis Pharmaceuticals [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded 02/15/2011
06/09/2010 Busman Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue Not Issued *
06/08/2010 Homeopathy For Health [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
06/08/2010 Piezosurgery Inc. [ARCHIVED] Cincinnati District Office CGMP for Medical Devices/QS/Adulterated 03/29/2011
06/07/2010 Arizant Inc [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Misbranded Not Issued *
06/07/2010 Mamma Lina's, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated 10/06/2011
06/07/2010 Dick-mar Farms [ARCHIVED] Philadelphia District Office Illegal Drug Residue Not Issued *
06/04/2010 Atlas Operations, Inc. [ARCHIVED] Florida District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated Not Issued *
06/04/2010 Troyer Farms [ARCHIVED] Detroit District Office Illegal Drug Residue 04/01/2011
06/03/2010 Baxter Healthcare Corporation [ARCHIVED] Chicago District Office Medical Device Reporting (MDR) Regulation/Adulterated 02/10/2017
06/03/2010 Twin Oaks Community Foods, Inc [ARCHIVED] Baltimore District Office Food Labeling/Misbranded 07/19/2011

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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