FDA WARNING_LETTER - Tris Pharma Inc. - March 20, 2017

The FDA issued a Warning Letter to Tris Pharma Inc. following a February-March 2017 inspection, citing significant CGMP violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate product failures and complaints, lacking root cause analysis and effective CAPA. This was a recurring issue from prior inspections (2011, 2012, 2014). * **Quillivant XR Dissolution Failures:** Five lots failed dissolution testing (release/stability). Investigations improperly invalidated OOS results, blaming the test method instead of manufacturing variability. The firm modified the FDA-approved dissolution method multiple times without adequate justification. FDA analysis confirmed dissolution failures, leading to a 2017 recall of five lots by Pfizer. The firm's response regarding sample handling and delayed testing was deemed inadequate, as it didn't fully address manufacturing process variability or the quality of all in-date lots. * **Morphine Sulfate Oral Solution Leaks/Under-fills:** At least 24 complaints (July-December 2016) regarding ~1,000 leaking/under-filled bottles were initially attributed to shipping damage. A thorough investigation, initiated post-inspection, identified defective caps with cracks. The firm's response was inadequate as defective product remained on