FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - February 10, 2023

An FDA inspection of Fujifilm Diosynth Biotechnologies USA, Inc. in Morrisville, NC, a drug substance manufacturer, revealed significant deficiencies in their quality system. Observations included the absence of a written quality agreement defining responsibilities for drug substance quality, a lack of established procedures for reporting biological product deviations, and insufficient studies to verify endotoxin clearance monitoring during purification.