• 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
July 22, 2009 Herbal Remedies Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 20, 2009 Phillips, Robert A., M.D. Center for Devices and Radiological Health Investigational Device Exemptions N/A *
July 17, 2009 La Madeleine Gourmet Foods, Inc. Dallas District Office Seafood HACCP/Adulterated N/A *
July 16, 2009 Thurston, Jeff Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 15, 2009 Mgs Soapopular Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 14, 2009 Van Raay Dairy Farm Cincinnati District Office Illegal Drug Residue N/A *
July 14, 2009 Perez Ident Peppers Dallas District Office Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food N/A *
July 10, 2009 Allera Health Products, Inc. Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 10, 2009 Universal Health Sciences Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 09, 2009 www.balanceayurvedic.com Los Angeles District Office Promotional Claims False & Misleading/Misbranded N/A *
July 08, 2009 Corporacion Los Hermanos, Inc. (DBA Panaderia America) San Juan District Office Food Product Manufacturing Facitity/Labeling N/A *
July 07, 2009 Hillcrest Bakery Inc. Seattle District Office CGMP Regulation For Food/Adulterated N/A *
July 07, 2009 Bazaar Of India San Francisco District Office New Drug/Labeling/Misbranded N/A *
July 06, 2009 Shanghai Co Inc Seattle District Office CGMP Regulation For Food/Adulterated N/A *
July 02, 2009 Gambro Dasco S.p.A. Bloodline Division Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
July 02, 2009 Christus St. Patrick Hospital IRB Center for Devices and Radiological Health CGMP for Medical Devices/QS/Adulterated N/A *
July 02, 2009 Gambro Renal Products S.A. de C.V. Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
July 01, 2009 R & Z Ventures dba Kennesaw Fruit & Juice Florida District Office Juice HACCP N/A *
July 01, 2009 Jones, Thomas M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
July 01, 2009 Rock Creek Dairy #3 Seattle District Office Illegal Drug Residue N/A *



 

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
-