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

Source: https://www.keypedia.com/records/483/bavarian-nordic-as/77e8691b-b76f-4670-8b0a-6aae3dd346b5

> 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: Office of Inspections and Investigations
- Summary: Bavarian Nordic A/S received a Form FDA 483 citing significant deficiencies in quality control and manufacturing processes at its Kvistgard facility. Observations included inadequate investigations into WFI and particulate contamination, failures in the aseptic process simulation program, and a lack of annual visual inspection for reserve samples. Additionally, the firm failed to report a biological product deviation within the mandated timeframe.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)
- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [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/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8