FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - April 21, 2021

An FDA inspection of Fujifilm Diosynth Biotechnologies USA, Inc. in Morrisville, NC, identified multiple significant deficiencies in their drug substance manufacturing operations. The firm failed to implement adequate risk assessments for cross-contamination, maintain proper process monitoring, and ensure robust material management and cleaning procedures. Furthermore, issues were noted in discrepancy investigations, microbial control, data integrity, and overall facility and equipment maintenance.