• 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

2008 Warning Letters

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

Warning Letters issued in 2008

 

* 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, 2008 Legacy Dairy Farms LP [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
October 09, 2008 Richards, Douglas L. [ARCHIVED] New York District Office Illegal Drug Residue N/A *
October 09, 2008 Blessing Inc. (DBA Blessing Seafood) [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
October 09, 2008 Jarrett Fertility Group, LLC [ARCHIVED] Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
October 08, 2008 Mackinac Straits Fish Company, inc. [ARCHIVED] Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
October 08, 2008 Citra Mina Seafood Corporation [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated N/A *
October 08, 2008 Organizaciion Agricultores Bo. Espino [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
October 07, 2008 Town of Bucksport [ARCHIVED] New England District Office PHS Act/Violation N/A *
October 07, 2008 F.B. Indian Ridge Dairy [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
October 06, 2008 Lisanby, Sarah H., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
October 02, 2008 Madespa S.A. [ARCHIVED] Center for Devices and Radiological Health CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
October 01, 2008 Holub, Richard, MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
September 30, 2008 Pure Prescriptions Inc. [ARCHIVED] Los Angeles District Office New Drugs N/A *
September 30, 2008 Wellmont Holston Valley Medical Center [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
September 30, 2008 Neuro Kinetics, Inc. [ARCHIVED] Philadelphia District Office Premarket Approval/Misbranded/Adulterated N/A *
September 29, 2008 Laboratory Corporation of America [ARCHIVED] Center for Devices and Radiological Health Device Lacks Marketing Clearance Approval/Adulterated/Misbranded N/A *
September 29, 2008 Lehman's Egg Service Inc. [ARCHIVED] Philadelphia District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded N/A *
September 26, 2008 Alpine Oral Care, LLC [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
September 25, 2008 Steris Corporation [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 25, 2008 Novartis Pharmaceuticals Corp [ARCHIVED] Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *



 

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
-