FDA 483 - FUJIFILM Diosynth Biotechnologies Denmark ApS - November 12, 2024

An FDA inspection of Fujifilm Diosynth Biotechnologies Denmark ApS in Hillerod revealed significant deficiencies across its drug substance manufacturing operations. The firm's Quality Unit demonstrated inadequate oversight, failing to ensure effective quality management, proper investigations, and adherence to procedures. Additionally, issues with electronic record integrity and incomplete production documentation were observed, indicating a broad lack of control over critical manufacturing processes.