# FDA 483 - FUJIFILM Diosynth Biotechnologies Denmark ApS - Unknown Date

Source: https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-denmark-aps/dacf2be1-401f-42e7-be9f-581ec8fa0c39

> FDA 483 for FUJIFILM Diosynth Biotechnologies Denmark ApS on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUJIFILM Diosynth Biotechnologies Denmark ApS
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Biogen (Denmark) Manufacturing ApS, a biological drug substance manufacturer in Hillerød, Denmark, was cited for significant deficiencies during an FDA inspection from October 7-11, 2019. Observations included issues with bioburden control, inadequate qualification of critical utilities, insufficient electronic data integrity controls, and failures in equipment validation and revalidation. These findings indicate a lack of robust quality systems for manufacturing and data management.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-denmark-aps/c200d7db-84cd-42a6-91b1-21de41d8d2ac)
- [483 - 2024-11-12](https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-denmark-aps/2ec35f9a-5f16-4fee-ad57-6599d261113d)

## Related Officers

- [Deborah H. Schmiel](https://www.keypedia.com/people/deborah-h-schmiel/facfc308-52af-4353-902a-0d45d5d88020)
- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321