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Tris Pharma, a CMO for Pfizer, hit with FDA warning letter for ADHD drug, morphine solution

April 12, 2018 / Joseph Keenan

Tris Pharma, a New Jersey-based CMO that manufactures the ADHD drug Quillivant for Pfizer, was hit with a warning letter by the FDA that cited significant violations. In the letter dated March 26, the regulatory agency said that an inspection of Tris’ facility in Monmouth Junction, New Jersey, in March 2017 turned up numerous production issues that violated current good-manufacturing practice regulations. Defect complaints and Tris' inadequate investigation of product failures were among the infractions. The agency said Tris “lacked thorough investigations into root causes, and failed to implement prompt and effective corrective actions and preventative actions.”