Lilly grand jury investigation
This article was originally published in The Gray Sheet
Executive Summary
Is focusing on Lilly's "compliance with FDA regulatory requirements affecting the company's manufacturing operations," Lilly says in a Feb. 19 release. The firm "believes that this inquiry arises out of a 1989 review that resulted in a voluntary agreement between Lilly and the FDA to strengthen the company's manufacturing quality systems." Lilly shut down one of its drug manufacturing facilities in August 1989 following receipt of a lengthy FD- 483 and reopened the plant in November of that year after signing an agreement with FDA. The investigation is being conducted through a Maryland grand jury.