Tris Pharma Slammed for Adulterated Products
The FDA warned Tris Pharma for manufacturing adulterated products at its Monmouth Junction, New Jersey facility, citing failures to properly investigate product defects and other deficiencies found during a March inspection.
The investigation found the firm produced five lots of Quillivant XR (methylphenidate HCl) that failed dissolution testing. Three lots failed during release testing and two failed during tests for stability. Laboratory tests of collected samples conducted by the agency also showed dissolution failures.
The agency said the firm normally invalidated out-of-specification results and blamed the dissolution test methods rather than manufacturing processes, and the facility did not adequately test sources of variation that might have been behind the issues.