FDA EIR - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - March 01, 2019

An FDA pre-license inspection of Fujifilm Diosynth Biotechnologies USA, Inc. (FDBU) was conducted from February 25 to March 1, 2019. This inspection supported the manufacture of a drug substance and was guided by regulatory frameworks including CPGM 7356.002M, CPGM 7346.832, and ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients. The inspection identified two main objectionable conditions, documented on a Form FDA 483. The first observation noted that the bioburden testing method for process performance qualification (PPQ) batches was not adequately validated. The second pertained to inadequate investigations of deviations, specifically citing the failure to send an exhaust air filter for further vendor testing after integrity test failures, and an inaccurate root cause determination for cleaning validation failures related to equipment dirty hold times. Additionally, verbal discussions addressed several discrepancies between the drug substance manufacturing process as described in the regulatory submission and the actual operations at the facility. FDBU management acknowledged these findings and committed to providing a formal response to the Agency within 15 business days. The client (sponsor) also indicated they were working on submitting corrections to the regulatory application to reconcile these process descriptions.