• 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

Section Contents Menu

Enforcement Actions

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
March 04, 2008 IMULUX, LLC Dallas District Office New Drug/False Misleading/Labeling/Misbranded N/A *
March 04, 2008 NeumaLife Kansas City District Office New Drug/False Misleading/Labeling/Misbranded N/A *
March 03, 2008 Midland Pharmaceutical LLC Kansas City District Office CGMP for Finished Pharmaceutical/Adulterated N/A *
March 03, 2008 Aviralex Int. San Francisco District Office Drug Labeling/Promotional Claims/Misbranded N/A *
March 03, 2008 Kwonnie Electrical Products Limited Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
March 03, 2008 Aidance Skincare & Topical Solutions, LLC New England District Office Drug Labeling/Promotional Claims/Misbranded N/A *
March 03, 2008 Kwonnie Electrical Products Limited Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 03, 2008 Taste Operating, Inc. San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
February 29, 2008 Philips Lifeline, Inc. Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
February 29, 2008 Johnson Dairy Denver District Office Illegal Drug Residue N/A *
February 26, 2008 Paskewitz, Barry J. Minneapolis District Office Illegal Drug Residue N/A *
February 25, 2008 Herbal Hope, Inc. Center for Food Safety and Applied Nutrition New Drug/Labeling/False & Misleading Claims N/A *
February 25, 2008 West Jefferson Medical Center IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) N/A *
February 21, 2008 InnoMed Technologies, Inc. and RespCare, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 20, 2008 Cochlear Bone Anchored Solutions AB Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
February 20, 2008 Isotron Ireland, Ltd. Center for Devices and Radiological Health CGMP for Medical Devices/Adulterated N/A *
February 19, 2008 SyntheMed Inc Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) N/A *
February 15, 2008 Wilmington Cold Storage, Inc. New England District Office Seafood HACCP/Adulterated N/A *
February 14, 2008 Blue Ribbon Meats Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
February 13, 2008 Klein, Kevin W., M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *



 

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
-