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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
04/05/2010 Innovative Directions in Health [ARCHIVED] Center for Drug Evaluation and Research Lipdissolve/False & Misleading Claims/Misbranded 02/10/2011
04/05/2010 7Seas LLC [ARCHIVED] Florida District Office Dietary Supplement Regulations/Misbranded Not Issued *
04/02/2010 Wright Place, LLC [ARCHIVED] New England District Office Illegal Drug Residue Not Issued *
04/01/2010 Deitz, Robert, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
04/01/2010 Yurkanin, John B [ARCHIVED] Philadelphia District Office Illegal Drug Residue Not Issued *
03/31/2010 Cut Fruit Express, Inc. [ARCHIVED] Minneapolis District Office CGMP for Foods/HACCP/Adulterated 02/08/2011
03/30/2010 Coats International Holdings, Inc [ARCHIVED] Dallas District Office CGMP Manufacture, Processing, Packing or Holding/Adulterated Not Issued *
03/30/2010 Wisconsin Brother's Bakery, Inc [ARCHIVED] Minneapolis District Office Labeling/False & Misleading Claims/Misbranded 07/01/2015
03/29/2010 Apotex Inc. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated 07/01/2011
03/29/2010 IVF Phoenix [ARCHIVED] Los Angeles District Office Human Cells, Tissues & Cellular Products 07/18/2011
03/26/2010 Pierre Fabre Medicament Production [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated 08/17/2011
03/26/2010 Liquid Manufacturing, L.L.C. [ARCHIVED] Detroit District Office Acidified Foods/Adulterated 01/07/2011
03/26/2010 Estrella Food Products, Inc. [ARCHIVED] San Juan District Office Food Labeling/Insanitary Conditions/Adulterated/Misbranded Not Issued *
03/25/2010 3CPM Company Inc [ARCHIVED] Baltimore District Office CGMP/QSR/Medical Devices/Adulterated 12/13/2010
03/25/2010 Today's Temptations, Inc. [ARCHIVED] Chicago District Office Food Labeling/Misbranded Not Issued *
03/24/2010 Roxy Trading Inc [ARCHIVED] Los Angeles District Office Adulterated Food Not Issued *
03/23/2010 Dornier Medtech America, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
03/23/2010 Simplydelicious [ARCHIVED] Denver District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions 01/19/2011
03/18/2010 Paragon Dx, LLC [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated 05/11/2010
03/17/2010 Tinnitus Control, Inc. [ARCHIVED] Center for Devices and Radiological Health Device/Lacks Annual Registration/Misbranded 05/10/2010
03/17/2010 KHL Inc [ARCHIVED] Center for Devices and Radiological Health Device/Misbranded 05/20/2010
03/17/2010 Chawla, Sant P., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator 07/29/2014
03/17/2010 Orthotic & Prosthetic Lab, Inc. [ARCHIVED] Center for Devices and Radiological Health Device/Lacks Annual Registration/Misbranded 05/10/2010
03/17/2010 Orthotic & Prosthetic Lab Inc. [ARCHIVED] Center for Devices and Radiological Health Device/Misbranded Not Issued *
03/17/2010 Empire Dairy [ARCHIVED] Denver District Office Illegal Drug Residue Not Issued *
03/17/2010 Providence Dairy, LLC [ARCHIVED] Detroit District Office Illegal Drug Residue 12/08/2010
03/17/2010 James P. Johnston, CO, dba Midwest Ocular Prosthetics [ARCHIVED] Center for Devices and Radiological Health Device/Misbranded, Not Issued *
03/17/2010 Vulcon Technologies Inc [ARCHIVED] Center for Devices and Radiological Health Device/Misbranded Not Issued *
03/17/2010 Tinnitus Control, Inc. [ARCHIVED] Center for Devices and Radiological Health Device/Misbranded Not Issued *
03/16/2010 Konec Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded 03/16/2011
03/16/2010 Glenmark Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded 03/16/2011
03/16/2010 Amerilab Technologies, Inc [ARCHIVED] Minneapolis District Office Labeling/New Drug/Misbranded 01/03/2011
03/15/2010 1008 Grinstead Mill Road Dairy [ARCHIVED] Cincinnati District Office Illegal Drug Residue 03/20/2012
03/15/2010 Healthy Body Forero [ARCHIVED] San Juan District Office New Drug/Labeling/False & Misleading Claims/Misbranded 02/11/2011
03/12/2010 Medline Industries Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded Not Issued *
03/12/2010 BTL Industries, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
03/12/2010 Merck & Co Inc. [ARCHIVED] Center for Veterinary Medicine New Animal Drug Application 09/13/2010
03/12/2010 Advanced Sterilization Products [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 06/02/2016
03/12/2010 Medispec, Ltd. [ARCHIVED] Center for Devices and Radiological Health Device/Lacks Premarket Approval Application/Adulterated/Misbranded 10/19/2010
03/12/2010 Endogastric Solutions Inc [ARCHIVED] Seattle District Office Medical Device Reporting (MDR) Regulation Misbranded/Adulterated 02/14/2012
03/11/2010 Toledo, Charles H., M.D. Center for Biologics Evaluation and Research Clinical Investigator - Human Trials 04/06/2010
03/11/2010 Talisman Limited [ARCHIVED] Baltimore District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
03/10/2010 NY Fish, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
03/10/2010 Clearwater Products, LLC [ARCHIVED] Florida District Office Medical Devices/Adulterated/Misbranded Not Issued *
03/08/2010 Double B Dairy, LLC [ARCHIVED] Seattle District Office Illegal Drug Residue Not Issued *
03/08/2010 Lin, Henry, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
03/08/2010 Frischs Commissary [ARCHIVED] Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated
03/05/2010 Otologics LLC [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
03/04/2010 Sun Technologies, Inc. [ARCHIVED] Center for Devices and Radiological Health Tanning Facility/Federal Performance Standard for Sunlamp Products/Misbranded Not Issued *
03/02/2010 Perez-Cruet, Miguelangelo J., M.D., M.S. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials Not Issued *

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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