FUJIFILM Diosynth Biotechnologies UK Limited – FDA 483, Sep 1, 2026
The FDA inspection of FUJIFILM Diosynth Biotechnologies UK Limited in Billingham revealed significant deficiencies in drug substance manufacturing. Key issues include inadequate out-of-specification (OOS) investigations lacking scientific evidence and corrective actions, along with poorly maintained facilities and equipment. The firm also demonstrated failures in quality control microbiology, labeling practices, adherence to manufacturing procedures, data integrity, and aseptic technique training.
- Inspection date
- September 1, 2026
- Product type
- drugs
ID · 5ce76d2d-cc33-4889-8cb3-d7c1ca2eabd0
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