# FDA 483 - Novo Nordisk A/S - March 25, 2024

Source: https://www.globalkeysolutions.net/records/483/novo-nordisk-as/a1d0c5be-baef-49e2-8029-c33585c3f80a

> FDA 483 for Novo Nordisk A/S on March 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novo Nordisk A/S
- Inspection Date: 2024-03-25
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Novo Nordisk A/S in Kalundborg Sjalland identified significant deficiencies in their drug substance manufacturing processes. Observations included inadequate water system sampling and control, incomplete manufacturing records and process descriptions, and insufficient validation documentation. These issues collectively indicate a lack of robust quality assurance and control over their drug substance production.

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## Related Officers

- [Zachary Kraus](https://www.globalkeysolutions.net/people/zachary-kraus/9a85297e-4a21-49a6-a848-bc4a1e759f1a)
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Company: https://www.globalkeysolutions.net/companies/novo-nordisk-as/b48359f1-0bb7-4fff-80dd-688aab40951b

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd