Pfizer Contract Manufacturer Slammed By US FDA For Dissolution Failures And Leaking Bottles

Tris Pharma is ultimately responsible for ensuring compliance with GMPs, warning letter states, even if Pfizer helped guide investigation of failed dissolution testing for ADHD drug Quillivant XR.

Warning Rubber Stamp

The US FDA's warning letter to Pfizer Inc. contract manufacturer Tris Pharma emphasizes the responsibilities that the contractor has to comply with GMP.

“You and your customer, Pfizer, have a quality agreement regarding the manufacture of drug products

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