FDA 483 - Tris Pharma Inc. - March 08, 2024

An FDA inspection of Tris Pharma Inc. in Monmouth Junction, NJ, identified significant deficiencies in their postmarketing adverse drug experience reporting system. The firm failed to include published scientific literature with numerous 15-day Alert reports and lacked comprehensive written procedures for adverse event surveillance, including those from social media. These observations highlight a need for improved pharmacovigilance practices at the facility.