• 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

2009 Warning Letters

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

Warning Letters issued in 2009

 

* 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
October 09, 2009 Laser Eye Care of California Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Lasik Vision Institute Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LCA Vision Inc Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 TLC Laser Eye Centers Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 08, 2009 Registry Steaks and Seafood Ltd Chicago District Office Food Labeling/Adulterated/Misbranded March 01, 2010
October 08, 2009 Tampa Peanut Distributors Florida District Office CGMP for Deviations/Adulterated July 01, 2010
October 08, 2009 Energy Miracle Enterprises Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded Not Issued *
October 08, 2009 www.novalistintegra.com Center for Biologics Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus December 01, 2009
October 07, 2009 Symmetry Medical USA, Inc New Orleans District Office CGMP/QSR/Adulterated/Misbranded February 11, 2011
October 07, 2009 Multi-Med, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated November 09, 2010
October 07, 2009 Basic American Foods Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 06, 2009 Washington Homeopathic Products, Inc. Center for Biologics Evaluation and Research Unapproved New Drug/Misbranded/False or Misleading Not Issued *
October 05, 2009 Mystical One LLC New York District Office CGMP for Foods/Juice HACCP/Adulterated Not Issued *
October 05, 2009 Burzynski Research Institute / IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
October 05, 2009 Phoenix Bio-Tech Corporation Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded Not Issued *
October 05, 2009 Crowley Foods Arkport, Division of HP Hood, LLC New York District Office Seafood HACCP/CGMP for Foods/Adulterated December 03, 2010
October 05, 2009 East Wind Community, Inc Kansas City District Office Manufacturing Facility/Adulterated/Insanitary conditions June 07, 2010
October 02, 2009 Medibo N.V. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated January 10, 2011
October 02, 2009 CTC Food International Inc San Francisco District Office Seafood HACCP Not Issued *
September 29, 2009 Phoenix Medical Devices, LLC Los Angeles District Office CGMP/QSR/Adulterated/Misbranded Not Issued *



 

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
-