# FDA 483 - Novo Nordisk A/S - 25a-B - January 17, 2020

Source: https://www.globalkeysolutions.net/records/483/novo-nordisk-as-25a-b/84ce6826-520f-4c13-83f3-58b02807c3d4

> FDA 483 for Novo Nordisk A/S - 25a-B on January 17, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novo Nordisk A/S - 25a-B
- Inspection Date: 2020-01-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Novo Nordisk A/S, a control testing laboratory in Hillerod, Denmark, was cited for failing to conduct thorough investigations into unexplained discrepancies. The firm did not adequately investigate unknown peaks detected multiple times during HPLC analysis, leading to an insufficient root cause determination. This indicates a significant lapse in their quality control and deviation management systems.

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## Related Officers

- [Jean Cantillops](https://www.globalkeysolutions.net/people/jean-cantillops/09262583-cd70-45ed-b701-91f02431b0fb)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1