# FDA 483 - Novo Nordisk A/S - 25a-B - November 07, 2023

Source: https://www.globalkeysolutions.net/records/483/novo-nordisk-as-25a-b/607a2091-1f1b-4f94-8d62-222c6a41de1a

> FDA 483 for Novo Nordisk A/S - 25a-B on November 07, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novo Nordisk A/S - 25a-B
- Inspection Date: 2023-11-07
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of Novo Nordisk A/S in Hillerod, Denmark, revealed significant deficiencies in preventing microbiological contamination of sterile drug products. The firm also failed to establish adequate control procedures to validate manufacturing processes, leading to variability and high false rejection rates in visual inspection. These observations indicate a need for improved aseptic processing controls and process validation.

## Related Documents

- [483 - 2020-01-17](https://www.globalkeysolutions.net/records/483/novo-nordisk-as-25a-b/84ce6826-520f-4c13-83f3-58b02807c3d4)

## Related Officers

- [Laurimer Kuilan-Torres](https://www.globalkeysolutions.net/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

Company: https://www.globalkeysolutions.net/companies/novo-nordisk-as-25a-b/017e6784-9871-4c62-9884-314e60ba61b7

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