• 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
May 15, 2009 Healing Edge Science [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Galloway Safety and Supply [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Nova Computers dba Nova Tech Gadgets [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Skilling Institute [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Huntington Beach Sunset Inc. [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Baptist Medical Center [ARCHIVED] Dallas District Office CGMP for Blood & Blood Components/Adulterated N/A *
May 14, 2009 Viral Defender [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Allerair Industries [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Luminex Corporation [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Resolveswineflu.com USA [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 13, 2009 Breathe More Easily Online [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 13, 2009 Emergency Disaster Systems [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 13, 2009 Sanuvox Technologies Inc. 5/13/09 [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 13, 2009 911 Water [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Boss Innovation & Marketing, Inc. [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Quake Kare, Inc. [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Healthy Choice Naturals [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 LifeSecure [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Whole World Botanicals [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Amyron Enterprises Pty Ltd. [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 12, 2009 Pyng Medical Corporation [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded N/A *
May 12, 2009 Howard Instruments Inc. 5/12/09 [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
May 11, 2009 Nexera Medical [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 11, 2009 Prodesse, Inc [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 11, 2009 Becton Dickinson & Company 5/11/09 [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 11, 2009 R4 LLC [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
May 11, 2009 Ageless Herbs [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 08, 2009 VitaCroft, LLP [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 07, 2009 L.P. Wholesale Seafood, Ltd. [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
May 07, 2009 Vaccaro's Italian Pastry Shop, Inc. [ARCHIVED] Baltimore District Office Current Good Manufacturing Practice Regulations for Human Foods/Adulterated N/A *
May 07, 2009 Hearn-Kirkwood Incorporated [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated/Misbranded N/A *
May 07, 2009 Samglo Enterprises [ARCHIVED] Detroit District Office Promotional Claims False & Misleading/Misbranded N/A *
May 07, 2009 Lupin Limited [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
May 06, 2009 Eureka Springs Hospital 5/6/09 [ARCHIVED] Dallas District Office Mammography Quality Standards Act N/A *
May 06, 2009 Synkem [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated N/A *
May 06, 2009 www.extremeimmunity.com [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 06, 2009 Elkhart General Hospital Blood Donor Center [ARCHIVED] Detroit District Office CGMP Regulations for Blood and Blood Components N/A *
May 05, 2009 Muvezi Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 05, 2009 The Secrets of Eden [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 05, 2009 General Mills, Inc. [ARCHIVED] Minneapolis District Office Promotional Claims False & Misleading/Misbranded N/A *
May 05, 2009 Stryker Craniomaxillofacial Division [ARCHIVED] Detroit District Office Premarket Approval/Misbranded/Adulterated N/A *
May 05, 2009 Susan Ambrosino's Herb Club, Inc. www.myherbs.net [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 04, 2009 Shaheen Brothers, Inc. [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
May 04, 2009 Rainbow Springs LLC, dba Star Prairie Trout Farm [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
May 03, 2009 Rebuilder Medical Technology, Inc [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
April 27, 2009 Nostrum Laboratories Inc [ARCHIVED] Kansas City District Office CGMP/Deviations/Adulterated N/A *
April 27, 2009 Hill Dermaceuticals, Inc. [ARCHIVED] Florida District Office CGMP for Finished Pharmaceutical/Adulterated N/A *
April 27, 2009 Pharma Pac LLC [ARCHIVED] New Orleans District Office CGMP for Deviations/Adulterated N/A *
April 24, 2009 Olay LLC. [ARCHIVED] San Juan District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
April 23, 2009 Central Peninsula General Hospital - Kenai Clinic [ARCHIVED] Seattle District Office Mammography Quality Standards Act N/A *

 

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
-