# FDA 483 - Novo Nordisk A/S - G8, X9 M.FI - April 17, 2026

Source: https://www.keypedia.com/records/483/novo-nordisk-as-g8-x9-mfi/921774a7-4084-422f-9c3d-7bbb7c10ca23

> FDA 483 for Novo Nordisk A/S - G8, X9 M.FI on April 17, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novo Nordisk A/S - G8, X9 M.FI
- Inspection Date: 2026-04-17
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Novo Nordisk's biopharmaceutical facility in Malov, Denmark, identified two observations concerning method validation activities for a drug product. The firm was cited for insufficient documentation of method validation activities, specifically regarding stability evaluations, and for failing to consistently adhere to established standard operating procedures during method validation experiments. These findings suggest potential gaps in the firm's quality control and data integrity practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/ruben-c-ayala/6b5dadad-56b8-4af0-a65f-4685f71f0c8d)

Company: https://www.keypedia.com/companies/novo-nordisk-as-g8-x9-mfi/389db4db-1347-40e5-88ef-284fdcfa1a1d

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8