Bavarian Nordic A/SDecember 9, 2025

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

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Record Details

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.

Company: Bavarian Nordic A/S
Inspection Date: December 9, 2025
Product Type: Biologics
Office: Office of Inspections and Investigations
People: Thai D. Truong (Investigator)
Peng Zhou
Feng Zhou

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ID · 77e8691b-b76f-4670-8b0a-6aae3dd346b5