Tris Pharma Hit with FDA Warning Letter for ADHD Drug


Tris Pharma, a New Jersey-based CMO for Pfizer, was hit with a warning letter from the FDA for its ADHD drug Quillivant. The warning letter cited significant violations.

According to the letter, an inspection of the company’s facility in Monmouth Junction, New Jersey found several production issues that violated good-manufacturing practice regulations. Infractions included inadequate investigation of product failures and defect complaints.

The letter said Tris was lacking “thorough investigations into root causes, and failed to implement prompt and effective corrective actions and preventative actions.”

The FDA stated that five lots of the Quillivant XR drug had failed dissolution testing between May and November 2016. Quillivant XR is an extended-release drug designed to treat ADHD.

Pfizer issued a voluntary recall of Quillivant last year due to lots not meeting the specification for dissolution.

The FDA, in an unusual move, named Pfizer in the letter.

“You and your customer, Pfizer, have a quality agreement regarding the manufacture of drug products,” the agency said. “You are responsible for the quality of drugs you produce as a contract facility, regardless of agreements in place with application sponsors.”

The company was also cited for 24 complaints involving 1,000 incidents of leaking or under-filled bottles of morphine sulfate. The FDA stated that Tris kept bottles with cracks in the liners in inventory without retesting.

“After this investigation, you attributed the leaks to a specific lot of caps that had cracks in their liners and remained in inventory for an extended time without retesting,” the FDA said in its letter. “Your response is inadequate. Defective product remained on the market for an additional eight months before you completed a thorough investigation and initiated a recall in July 2017.”

Pfizer does offer a morphine sulfate product under its Avinza brand, but the FDA did not state that this was the product recalled by Tris.