FDA 483 - FinVector Oy

An FDA inspection of Fin Vector Oy in Kuopio, Finland, a drug substance and drug product manufacturer, revealed six observations. These included inadequate qualified personnel, poorly maintained manufacturing equipment leading to breakdowns, a quality system allowing planned deviations for equipment issues, and insufficient procedures to prevent contamination. Additionally, cleaning equipment for drug product components was not adequately maintained, and validation documentation for labeling and packaging equipment was incomplete.