Contract Manufacturing / cGMPs

Tris Pharma, a Pfizer CMO, warned by FDA

Apr 13, 2018

The U.S. FDA sent a Warning Letter to Tris Pharma, a CMO that manufacturers ADHD drug, Quillivant, for Pfizer, citing significant violations of CGMP regulations.

The March 26, 2018 letter references an inspection of Tris’ Monmouth Junction, NJ facility in March 2017 and the CMO’s subsequent response to the violations.

The letter noted ongoing dissolution failures with Pfizer’s Quillivant XR, a drug approved by the FDA in 2013. The agency made it clear the responsibility lies with the CMO, stating, "FDA regards contractors as extensions of the manufacturer. You and your customer, Pfizer, have a quality agreement regarding the manufacture of drug products. You are responsible for the quality of drugs you produce as a contract facility, regardless of agreements in place with application sponsors."

The letter also mentions that Tris did not adequately evaluate other possible root causes of complaints for 1,000 leaking or under-filled bottles of morphine until after inspection — but did not mention the drugmakers associated with the product.

Read the FDA Warning Letter