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

Source: https://www.globalkeysolutions.net/records/483/fujifilm-diosynth-biotechnologies-uk-limited/b6518583-794c-4d2f-baec-63423c36352e

> FDA 483 for FUJIFILM Diosynth Biotechnologies UK Limited on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUJIFILM Diosynth Biotechnologies UK Limited
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of FUJIFILM Diosynth Biotechnologies UK Limited in Billingham, United Kingdom, a drug substance manufacturer, revealed significant issues with process controls. The firm failed to prevent microbial contamination in multiple batches of drug substance and detected organisms of concern in its environmental monitoring program. This indicates a serious lapse in maintaining a sterile manufacturing environment.

## Related Officers

- [Libia Lugo](https://www.globalkeysolutions.net/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.globalkeysolutions.net/companies/fujifilm-diosynth-biotechnologies-uk-limited/1ab271fe-bbf2-4dec-a2b8-1ae59ca0f082

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1