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

Source: https://www.globalkeysolutions.net/records/483/fujifilm-diosynth-biotechnologies-denmark-aps/c200d7db-84cd-42a6-91b1-21de41d8d2ac

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

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## Details

- Record Type: 483
- Company Name: FUJIFILM Diosynth Biotechnologies Denmark ApS
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Biogen (Denmark) Manufacturing ApS, a drug substance manufacturer in Hillerod, Denmark, was cited for inadequate laboratory testing procedures during an FDA inspection. The firm lacked defined time limits for performing tests after in-process sample collection, specifically for endotoxin samples. This included a lack of studies to support storage conditions for these samples.

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- [483 - 2024-11-12](https://www.globalkeysolutions.net/records/483/fujifilm-diosynth-biotechnologies-denmark-aps/2ec35f9a-5f16-4fee-ad57-6599d261113d)

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

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