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

An FDA inspection of FUJIFILM Diosynth Biotechnologies Texas, LLC in College Station, Texas, a biological drug substance manufacturer, revealed significant deficiencies across multiple quality systems. Observations included inadequate quality control procedures, unvalidated analytical methods, insufficient process validation, and poor environmental monitoring. The firm also failed to thoroughly investigate discrepancies, maintain adequate written procedures, and ensure data integrity.