FDA 483 - FUJIFILM Diosynth Biotechnologies UK Limited - March 17, 2023

An FDA inspection of FUJIFILM Diosynth Biotechnologies UK Limited in Billingham, United Kingdom, a drug substance manufacturer, revealed significant issues with process controls. The firm failed to prevent microbial contamination in multiple batches of drug substance and detected organisms of concern in its environmental monitoring program. This indicates a serious lapse in maintaining a sterile manufacturing environment.