FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - November 07, 2023

Fujifilm Diosynth Biotechnologies Texas, LLC, a monoclonal antibody manufacturer in College Station, TX, was inspected and found to have significant deficiencies across multiple areas. These include widespread failures to follow or establish adequate procedures, lack of validation for critical manufacturing processes and storage conditions, inadequate data integrity controls, and issues with material management leading to contamination.