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.
The firm also failed to thoroughly investigate manufacturing process variables that might have been responsible for inconsistent product quality. In addition, the firm did not fully assess the quality of all in-date Quillivant XR lots released for or awaiting distribution in the U.S.
The agency called for an update on a review of all dissolution and assay failures for the lots and a risk assessment for the quality of all batches out for distribution. It also requested an update on investigations and corrective and preventive actions launched to address the issues.
Leaking or under-filled morphine sulfate oral solution bottles were also an issue, with 24 complaints sent to the firm between July and December 2016. The customers complained that they found approximately 1,000 leaking or under-filled bottles of the product.
The firm’s initial investigation of the bottles concluded that the damage likely occurred during shipping and was outside its control, but the company did not adequately evaluate other possibilities until after the FDA’s inspection.
Tris Pharma eventually determined the leaks came from a supply of bottle caps that had cracks in them. The caps remained in the facility’s inventory for an extended time without retesting. The defective product remained on the market for an additional eight months before a thorough investigation was undertaken and a recall was issued, the agency said.