FDA 483 - FinVector Oy - May 28, 2024

FinVector Oy, a biologics/viral vector facility in Kuopio, Finland, was cited with five observations during an FDA inspection. The observations highlight significant deficiencies in quality control, supplier management, equipment maintenance, and process validation. These issues include inadequate validation of supplier test results for primary containers and raw materials, lack of procedures for reserve sample inspection, and insufficient validation of critical process parameters for cell infection.