• 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
07/14/2009 Van Raay Dairy Farm [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
07/14/2009 Perez Ident Peppers [ARCHIVED] Dallas District Office Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food N/A *
07/10/2009 Allera Health Products, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
07/10/2009 Universal Health Sciences [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
07/09/2009 www.balanceayurvedic.com [ARCHIVED] Los Angeles District Office Promotional Claims False & Misleading/Misbranded N/A *
07/08/2009 Corporacion Los Hermanos, Inc. (DBA Panaderia America) [ARCHIVED] San Juan District Office Food Product Manufacturing Facitity/Labeling N/A *
07/07/2009 Hillcrest Bakery Inc. [ARCHIVED] Seattle District Office CGMP Regulation For Food/Adulterated N/A *
07/07/2009 Bazaar Of India [ARCHIVED] San Francisco District Office New Drug/Labeling/Misbranded N/A *
07/06/2009 Shanghai Co Inc [ARCHIVED] Seattle District Office CGMP Regulation For Food/Adulterated N/A *
07/02/2009 Christus St. Patrick Hospital IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
07/02/2009 Gambro Dasco S.p.A. Bloodline Division [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
07/02/2009 Gambro Renal Products S.A. de C.V. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
07/01/2009 Sparkle Spring Water Inc. [ARCHIVED] Atlanta District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions N/A *
07/01/2009 Rock Creek Dairy #3 [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
07/01/2009 R & Z Ventures dba Kennesaw Fruit & Juice [ARCHIVED] Florida District Office Juice HACCP N/A *
07/01/2009 Northwest Tofu, Inc. [ARCHIVED] Seattle District Office Current Good Manufacturing Practice Regulations for Human Foods/Adulterated N/A *
07/01/2009 Jones, Thomas M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
06/30/2009 J-Tel, Inc dba Buxton Foods [ARCHIVED] Minneapolis District Office Labeling/False & Misleading Claims/Misbranded N/A *
06/29/2009 Sylvane Inc. [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/29/2009 Banyan Botanicals [ARCHIVED] Denver District Office New Drug/Labeling/Misbranded N/A *
06/29/2009 Staten Island University Hospital IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
06/26/2009 Gaven Medical [ARCHIVED] New England District Office CGMP/QSR/Adulterated N/A *
06/26/2009 FAVPEP LLC. dba Queenmar LLC. [ARCHIVED] Florida District Office Adulterated Food N/A *
06/26/2009 Advanced Neuromodulation Systems, Inc [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
06/26/2009 Gordon, Mark, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
06/25/2009 Apotex Inc. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
06/25/2009 Chesterfield Dairy [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
06/25/2009 IntelSource Group Inc dba Electro Medical Technologies LLC [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated N/A *
06/25/2009 Laboratoire Atlas Inc. [ARCHIVED] Center for Drug Evaluation and Research Pharmaceutical Manufacturing Facility/CGMP N/A *
06/24/2009 Accumed Inc. [ARCHIVED] New Jersey District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated N/A *
06/23/2009 Nutronix [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/23/2009 Island Supplements [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/23/2009 Apotheca Inc [ARCHIVED] Los Angeles District Office CGMP Manufacture, Processing, Packing or Holding/Adulterated N/A *
06/22/2009 Circle T Dairy [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
06/18/2009 Las Botanas [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
06/18/2009 Natren, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/17/2009 Niitikaya USA Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
06/16/2009 Zosa, Noli R., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
06/16/2009 International Desserts and Delicacies [ARCHIVED] Los Angeles District Office CGMP Regulation For Food/Adulterated N/A *
06/16/2009 Matrixx Initiatives, Inc. AKA Zicam LLC [ARCHIVED] Center for Drug Evaluation and Research OTC Drug Labeling/New Drug/Misbranded N/A *
06/15/2009 Arkray Factory, Inc. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
06/15/2009 Sunshine Peanut Company [ARCHIVED] Florida District Office CGMP/Foods/Insanitary Conditions N/A *
06/15/2009 Dennis Paper and Food Service [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
06/12/2009 Linzer, Dov M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
06/12/2009 Circle of Health, Inc, www.ayurveda-herbs.com [ARCHIVED] Seattle District Office New Drug/Labeling/Misbranded N/A *
06/11/2009 Meridian Lifeforce, Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
06/10/2009 Inditherm Medical [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
06/10/2009 Arjo Med. AB [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
06/09/2009 Universal Blanchers LLC [ARCHIVED] Dallas District Office CGMP/Adulterated N/A *
06/08/2009 DS Waters of America, LP [ARCHIVED] Center for Food Safety and Applied Nutrition Misbranded/Labeling/Unauthoriz ed Health Claims N/A *

 

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
-