483
Tris Pharma Inc.Tris Pharma Inc. – FDA 483, Nov 21, 2025
Record Details
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.
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