Start Date: 2000
Financial penalties: none
End Date: 2005
Scope involved GMP violations in the methods, facilities and controls for Fluogen, an influenza vaccine. The violations occurred in manufacturing, processing and packaging. The FDA also identified process validation problems related to Aplisol, a diagnostic agent for detecting tuberculosis, but addressed them separately.
The consent decree was issued in March 2000 and was lifted in July 2005.