# FUJIFILM Diosynth Biotechnologies UK Limited – FDA 483, Sep 1, 2026

Source: https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-uk-limited/5ce76d2d-cc33-4889-8cb3-d7c1ca2eabd0

> FDA 483 for FUJIFILM Diosynth Biotechnologies UK Limited on September 01, 2026. 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: 2026-09-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [483 - 2023-03-17](https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-uk-limited/b6518583-794c-4d2f-baec-63423c36352e) — date: March 17, 2023

## Related Officers

- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)
- [Senior Research Scientist](https://www.keypedia.com/people/nozomi-sakakibara/fd3ec0a2-f3a9-4c36-a67e-cecdfb7cd988)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8