Gliatech guilty plea
This article was originally published in The Gray Sheet
Executive Summary
Adcon-L developer faces up to $1.2 mil. in fines and a five-year probation under an agreement with the Justice Department. Gliatech pleads guilty to six misdemeanors, including failure to submit Medical Device Reports to FDA, adulteration of a medical device, and the submission of false reports to FDA. The agency currently is reviewing the company's Application Integrity Policy (AIP) corrective action plan (CAP), which was submitted in November 2001. The anti-adhesion product was taken off the U.S. market in January 2001 and is only available internationally...