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.”
In an unusual move by the FDA, named Pfizer in the letter, saying that five lots of its branded Quillivant XR (methylphenidate HCI) failed dissolution testing between May and November 2016. Quillivant XR is an extended-release oral suspension used to treat ADHD. Last year, Pfizer issued a voluntary recall of the drug because a number of lots didn’t meet the specification for dissolution.
“You and your customer, Pfizer, have a quality agreement regarding the manufacture of drug products,” the FDA said. “You are responsible for the quality of drugs you produce as a contract facility, regardless of agreements in place with application sponsors.”
Tris was also cited regarding 24 complaints involving about 1,000 leaking or under-filled bottles of morphine sulfate. The agency said that despite discovering bottles with cracks in the liners, Tris kept the products in inventory without being retested.
“Defective product remained on the market an additional eight months before you completed a thorough investigation and initiated a recall in July 2017.”
Although Pfizer sells a morphine sulfate product under the name Avinza, the FDA didn’t specify in its letter if that was the subject of the Tris recall last year.