FDA warns Celltrion of GMP violations at Inflectra facility

FDA issued a warning letter to Celltrion Inc. (KOSDAQ:068270) on Jan. 26 identifying "significant violations" of GMP regulations regarding production of Inflectra biosimilar infliximab-dyyb (CT-P13) at its manufacturing facility in Incheon, South Korea.

According to the letter, in May 2017 an agency investigator observed "multiple poor aseptic practices" during the set-up and filling of an Inflectra batch, to which Celltrion responded with a revised aseptic technique procedures. FDA wrote that the company's response was "inadequate" because it did not perform a retrospective investigation and thorough risk assessment and that the revised procedure "permits contamination...followed by wiping with a disinfectant, instead of preventing sterile equipment contamination by improved design and procedures."...