FDA 483 - FinVector Oy

FinVector Oy, a drug substance and drug product manufacturer in Kuopio, Finland, was inspected and found to have significant deficiencies across its quality system. Key issues include inadequate Quality Assurance oversight, poorly defined quality procedures, inadequately qualified quality control assays, and deficiencies in aseptic operations, cleaning, and disinfection. The inspection also revealed problems with shipping validation, lack of procedures for commercial lot manufacturing, insufficient employee training, and inadequate management of GMP data.