FDA 483 - FUJIFILM Diosynth Biotechnologies UK Limited - March 17, 2023

During an FDA inspection conducted from March 13-17, 2023, FUJIFILM Diosynth Biotechnologies UK Limited, a drug substance manufacturer located in Billingham, United Kingdom, received inspectional observations concerning significant issues with process controls and contamination. The main violations identified revolve around the company's inability to prevent microbial contamination of drug substances during manufacturing processes. Specifically, the inspection revealed instances between September 2021 and August 2022 where three batches of drug substance were found to have microbial contamination, with bioburden test results exceeding established limits and recovering organisms of concern. Investigations by the firm indicated potential gaps in their process controls. Furthermore, since August 2021, the company's environmental monitoring program consistently detected organisms of concern in various site areas, including those directly supporting manufacturing. While the FDA's observations do not represent a final compliance determination, they highlight serious quality control deficiencies. In response, FUJIFILM Diosynth Biotechnologies UK Limited has reportedly implemented, and continues to implement, follow-up measures and multiple corrective and preventive actions to strengthen process controls and eliminate potential sources of contamination. These actions are crucial for ensuring product quality and patient safety, aligning with the good manufacturing practices expected of a drug substance manufacturer.