FDA 483 - Corcept Therapeutics Incorporated - May 09, 2014

Co-Cept Therapeutics Incorporated, a sponsor, was inspected from May 5-9, 2014, revealing significant deficiencies in their postmarketing adverse drug experience reporting system. The firm lacked comprehensive written procedures for the surveillance, receipt, evaluation, and reporting of adverse drug experiences to the FDA. This included inadequate oversight of outsourced pharmacovigilance vendors and a failure to establish procedures for NDA Field Alert Reports.