# FDA 483 - FUJIFILM Diosynth Biotechnologies Denmark ApS - November 12, 2024

Source: https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-denmark-aps/2ec35f9a-5f16-4fee-ad57-6599d261113d

> FDA 483 for FUJIFILM Diosynth Biotechnologies Denmark ApS on November 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUJIFILM Diosynth Biotechnologies Denmark ApS
- Inspection Date: 2024-11-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Fujifilm Diosynth Biotechnologies Denmark ApS in Hillerod revealed significant deficiencies across its drug substance manufacturing operations. The firm's Quality Unit demonstrated inadequate oversight, failing to ensure effective quality management, proper investigations, and adherence to procedures. Additionally, issues with electronic record integrity and incomplete production documentation were observed, indicating a broad lack of control over critical manufacturing processes.

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## Related Officers

- [Richard Ledwidge, Ph.D., Biologist](https://www.keypedia.com/people/richard-ledwidge-phd-biologist/51161c1e-63da-4f24-bf8b-ecc1398c9dbe)
- [Mamta Kapoor-Bhushan, Pharmaceutical Scientist](https://www.keypedia.com/people/mamta-kapoor-bhushan-pharmaceutical-scientist/5a3b63c1-5098-4faf-bc13-55970643951e)
- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)
- [David Anderson, Supervisory Chemist](https://www.keypedia.com/people/david-anderson-supervisory-chemist/b003806f-eb3f-434a-a477-8e83ccba1bf3)
- [Leiyun Boone, PhD, Lead Biologist](https://www.keypedia.com/people/leiyun-boone-phd-lead-biologist/bff36082-6e40-4d97-b452-8b89d415e5be)

Company: https://www.keypedia.com/companies/fujifilm-diosynth-biotechnologies-denmark-aps/513b3c42-1517-43bc-936a-d3edd26bed70

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