FDA 483 - Tris Pharma Inc. - November 21, 2025

An FDA inspection of Tris Pharma Inc. in Monmouth Junction, NJ, revealed significant and recurring product quality issues, particularly with their (b)(4) Extended-Release Oral Suspension. The firm failed to conduct thorough investigations into repeated dissolution failures, assay and density discrepancies, and did not implement effective corrective actions. This is a repeat observation from a previous FDA 483.