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

An FDA inspection of Fujifilm Diosynth Biotechnologies in Morrisville, NC, from October 22-26, 2018, revealed significant deficiencies in quality control and manufacturing processes. Observations included inconsistencies in release testing specifications, inadequate materials management with expired items, and systemic failures in deviation investigation and CAPA implementation. Additionally, laboratory controls for analytical methods, particularly peak integration, were found to be insufficient.