FDA 483 - FinVector Oy

An FDA inspection of Fin Vector Oy in Kuopio, Finland, a drug substance and drug product manufacturer, revealed multiple significant deficiencies. Observations included inadequate qualified personnel, poor equipment maintenance leading to breakdowns, and a quality system allowing for planned deviations. Additionally, issues with contamination prevention procedures, inadequate cleaning equipment maintenance, and incomplete validation for labeling and packaging equipment were noted.