FDA EIR - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - April 21, 2021

An FDA inspection of Fujifilm Diosynth Biotechnologies U.S.A., Inc. (FDBU) in Research Triangle Park, NC, was conducted from April 14-21, 2021. This combined CGMP surveillance and pre-license inspection, performed under regulatory guidelines including ICH Q7, focused on the facility's Quality, Facilities and Equipment, Production, Materials, and Laboratory Control systems. The inspection identified ten significant observations, resulting in a Form FDA 483. Key issues included inadequate formal risk assessments for cross-contamination, insufficient monitoring and control of manufacturing processes, and deficiencies in material management systems. The FDA also noted inadequate cleaning and sanitization procedures, incomplete investigations of discrepancies, and poorly implemented corrective actions. Furthermore, concerns were raised regarding microbial control, inadequate microbial hold time studies, and non-adherence to written procedures by staff. Data integrity was compromised by a lack of procedural controls for electronic acquisition systems, and manufacturing areas and equipment were found to be improperly designed, maintained, and labeled. FDBU management acknowledged the observations and committed to submitting a response within 15 days. The initial FDA recommendation was "Withhold" for the pre-license application, indicating that significant actions are required for approval, and "Voluntary Action Indicated" for surveillance, meaning corrective actions are expected.