Start Date: 1989
Financial penalties: none
End Date: Still pending
This consent decree stems from GMP violations at a facility in Puerto Rico. A reorganization yielded groups within the company designed to prevent conflict of interest.
Although no financial penalty was assessed, Eli Lilly suffered the delayed approval of two drugs when inspectors found GMP issues during a pre-approval inspection in 2001. The company and FDA agreed on fixes in 2002, but subsequent violations have left the matter unresolved.