FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - March 11, 2025
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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.
ID · fc23b2a4-12b7-4de5-976a-6d3dc24ac571