FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - March 11, 2025

Fujifilm Diosynth Biotechnologies Texas, LLC, a drug substance manufacturer in College Station, TX, was cited for significant deficiencies across its manufacturing, quality control, and data management systems. Observations included inadequate controls for cross-contamination, deficient cleaning and environmental monitoring, unvalidated QC test methods, and a lack of proper controls for electronic data integrity. The firm also failed to follow its own SOPs for stability testing and contractor qualification, indicating systemic issues in maintaining a state of control.