FDA 483 - FinVector Oy - March 04, 2026
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FinVector Oy, a drug substance manufacturer in Kuopio, Finland, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate data integrity for batch production records, ineffective management of deviations and corrective actions for recurring issues like HEPA filter leakages and pest infestations, and failure to follow written production procedures. Additionally, critical manufacturing materials were not routinely monitored, and cleaning procedures for the raw materials warehouse were not established.
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