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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
02/17/2010 Body Tools [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/16/2010 Nature'S Gift Inc [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus Not Issued *
02/16/2010 Songkla Canning Public Company Limited [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP Not Issued *
02/16/2010 Gourmet Express Marketing, Inc. [ARCHIVED] Chicago District Office Seafood HACCP/CGMP/Misbranded Not Issued *
02/16/2010 Biological Controls [ARCHIVED] New Jersey District Office CGMP/QSR/Adulterated/Misbranded 06/15/2011
02/16/2010 Crestview Calves, Inc. [ARCHIVED] Seattle District Office Illegal Drug Residue Not Issued *
02/16/2010 La Mexicana, Inc. [ARCHIVED] Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions Not Issued *
02/12/2010 Wu, Helen K. [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 07/29/2011
02/12/2010 LCA Vision Inc/Lasik Plus Vision Center [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 08/16/2011
02/12/2010 Lasik Vision Institute [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
02/12/2010 LASIK Vision Institute LLC [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
02/12/2010 Huyard, Christian M. [ARCHIVED] Philadelphia District Office Illegal Drug Residue Not Issued *
02/11/2010 Rangen Inc [ARCHIVED] Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Not Issued *
02/09/2010 P & D Dairy [ARCHIVED] Los Angeles District Office Illegal Drug Residue Not Issued *
02/09/2010 Lomeo, Simon J. [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
02/09/2010 Breckenridge Pharmaceutical, Inc. [ARCHIVED] Florida District Office New Drug/Adulterated Not Issued *
02/08/2010 Jaymac Pharmaceuticals LLC [ARCHIVED] New Orleans District Office New Drug/Adulterated Not Issued *
02/08/2010 Magna Pharmaceuticals, Inc [ARCHIVED] Cincinnati District Office Labeling/False & Misleading Claims/New Drug/Misbranded Not Issued *
02/08/2010 Edwards Pharmaceuticals, Inc [ARCHIVED] New Orleans District Office New Drug/Adulterated Not Issued *
02/08/2010 Poly Pharmaceuticals, Inc [ARCHIVED] New Orleans District Office New Drug/Adulterated Not Issued *
02/05/2010 Lilly del Caribe, Inc. (PR05) [ARCHIVED] San Juan District Office CGMP/Active Pharmaceutical Ingredients/Adulterated Not Issued *
02/05/2010 Deston Therapeutics, LLC. [ARCHIVED] Atlanta District Office Labeling/New Drug/Misbranded Not Issued *
02/05/2010 Cardiac Science Corporation [ARCHIVED] Seattle District Office CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
02/04/2010 Kirk Pharmaceuticals, LLC [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
02/04/2010 Punjwani, Sohail S., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
02/04/2010 Summers, Timothy, MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
02/03/2010 Garden-Fresh Foods, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP Not Issued *
02/03/2010 IPCH Management, Inc [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/02/2010 Societe Nouvelle Averio Maroc [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
02/02/2010 Portal Pharmaceutical, Inc. [ARCHIVED] San Juan District Office Labeling/New Drug Application 07/06/2010
01/28/2010 Nasr, Samya, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
01/28/2010 Xian Libang Pharmaceutical Co., Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Manufacturing Facility/Active Pharmaceutical Ingredient 07/07/2011
01/27/2010 OST Medical, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated 07/11/2012
01/27/2010 Kellogg USA [ARCHIVED] Atlanta District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions 08/15/2012
01/26/2010 Fertility and Reproductive Medicine Center for Women [ARCHIVED] Florida District Office Human Cells, Tissues & Cellular Products 09/29/2010
01/26/2010 www.ayurvediccure.com [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
01/25/2010 Venus Foods Inc [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
01/25/2010 Meyer Food Service LLC dba Empire Fish Co [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated Not Issued *
01/22/2010 Medisound Inc [ARCHIVED] Florida District Office Mammography Quality Standards Act Not Issued *
01/22/2010 Cardiovascular Diagnostic Image, Inc. [ARCHIVED] Florida District Office Mammography Quality Standards Act Not Issued *
01/19/2010 Sun Hang Bean Sprout Inc [ARCHIVED] Detroit District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions Not Issued *
01/19/2010 Cayman Chemical Company [ARCHIVED] Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
01/19/2010 SweetSommer Water Bottling Company, LLC. [ARCHIVED] Baltimore District Office Processing and Bottling of Bottled Drinking Water/Adulterated Not Issued *
01/19/2010 Crown Health Care Laundry Services, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation Not Issued *
01/15/2010 Baxter Biosciences [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations 03/22/2010
01/15/2010 Cybernet Systems Corp. [ARCHIVED] Detroit District Office CGMP/QSR/Adulterated/Misbranded 04/15/2011
01/15/2010 McNeil Consumer and Specialty Pharmaceuticals [ARCHIVED] San Juan District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated Not Issued *
01/14/2010 Sunrise Pharmaceutical, Inc. [ARCHIVED] New Jersey District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded 12/20/2011
01/14/2010 Premium Dental, LLC [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated 02/04/2011
01/14/2010 Boonesboro Animal Clinic Corporation [ARCHIVED] Cincinnati District Office Illegal Drug Residue 12/06/2011

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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