# FDA 483 - Bavarian Nordic A/S - December 09, 2025

Source: https://www.keypedia.com/records/483/bavarian-nordic-as/4d86cc91-e12e-4bf6-b80d-653a1c4d0c75

> FDA 483 for Bavarian Nordic A/S on December 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bavarian Nordic A/S
- Inspection Date: 2025-12-09
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: Bavarian Nordic A/S, a licensed biological drug manufacturer in Kvistgard, Denmark, was cited for significant quality control failures during an FDA inspection. Observations included inadequate investigations into Water for Injection (WFI) and particulate contamination affecting Jynneos vaccine and other drug products, and deficiencies in their Aseptic Process Simulation program. Additionally, the firm failed to visually inspect reserve samples and did not report a biological product deviation within the required timeframe.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)
- [Feng Zhou](https://www.keypedia.com/people/feng-zhou/5cb267f1-2c3a-487c-b46d-ac1734d08bf9)

Company: https://www.keypedia.com/companies/bavarian-nordic-as/c5568360-841f-40cc-a482-d0fe7d40b4e1

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917