Tris Pharma Inc. – FDA 483, Jun 8, 2021

An FDA inspection of Tris Pharma Inc. in Monmouth Junction, NJ, from May to June 2021, revealed significant deficiencies across its quality system, facility maintenance, and manufacturing controls. Observations included inadequate quality unit procedures, failure to properly investigate product complaints and submit field alert reports, and issues with personnel gowning leading to product contamination. The findings highlight a systemic breakdown in ensuring drug product quality and safety.