FDA 483 - Indivior, Inc. - October 19, 2017

An FDA inspection of Indivior Inc. in Richmond, VA, revealed a failure to ensure proper monitoring of clinical study RB-US-13-0001. Specifically, the firm did not adhere to its Oversight Monitoring Plan, leading to issues with essential document review, monitoring visit report review, and final unblinded monitoring visits. These deficiencies resulted in inadequate drug accountability and reconciliation at study sites.