FDA 483 - FinVector Oy - May 28, 2024

An FDA inspection of FinVector Oy's biologics/viral vector facility in Kuopio, Finland, revealed several significant deficiencies. These included inadequate validation of supplier analyses for container/closure systems and raw materials, a lack of robust quality control unit oversight for procedures and reserve sample inspection, and insufficient validation of critical process parameters for cell infection. The firm also lacked proper written procedures for equipment maintenance and material sampling and testing.