• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

2010 Warning Letters

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

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

 
-
Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 16, 2010 Konec Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded March 16, 2011
March 16, 2010 Glenmark Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded March 16, 2011
March 16, 2010 Amerilab Technologies, Inc [ARCHIVED] Minneapolis District Office Labeling/New Drug/Misbranded January 03, 2011
March 16, 2010 Tomaso's Specialty Foods San Francisco District Office CGMP Regulation For Foods/Adulterated/Misbranded/Insanitary Conditions Not Issued *
March 15, 2010 1008 Grinstead Mill Road Dairy [ARCHIVED] Cincinnati District Office Illegal Drug Residue March 20, 2012
March 15, 2010 Healthy Body Forero [ARCHIVED] San Juan District Office New Drug/Labeling/False & Misleading Claims/Misbranded February 11, 2011
March 12, 2010 Medline Industries Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded Not Issued *
March 12, 2010 BTL Industries, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
March 12, 2010 Merck & Co Inc. [ARCHIVED] Center for Veterinary Medicine New Animal Drug Application September 13, 2010
March 12, 2010 Advanced Sterilization Products [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 12, 2010 Medispec, Ltd. [ARCHIVED] Center for Devices and Radiological Health Device/Lacks Premarket Approval Application/Adulterated/Misbranded October 19, 2010
March 12, 2010 Endogastric Solutions Inc [ARCHIVED] Seattle District Office Medical Device Reporting (MDR) Regulation Misbranded/Adulterated February 14, 2012
March 11, 2010 Toledo, Charles H., M.D. Center for Biologics Evaluation and Research Clinical Investigator - Human Trials April 06, 2010
March 11, 2010 Talisman Limited [ARCHIVED] Baltimore District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
March 10, 2010 NY Fish, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 10, 2010 Clearwater Products, LLC [ARCHIVED] Florida District Office Medical Devices/Adulterated/Misbranded Not Issued *
March 08, 2010 Double B Dairy, LLC [ARCHIVED] Seattle District Office Illegal Drug Residue Not Issued *
March 08, 2010 Lin, Henry, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
March 08, 2010 Frischs Commissary [ARCHIVED] Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated
March 05, 2010 Otologics LLC [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *



 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

-