NextPharma OY – FDA 483, Sep 6, 2022

NextPharma OY, a contract sterile drug manufacturer in Tampere, Finland, received a Form 483 with six observations related to significant deficiencies in manufacturing process controls, sterilization validation, aseptic practices, equipment maintenance, facility repair, and environmental monitoring. These issues indicate a lack of readiness for commercial sterile drug product manufacturing and potential risks to product quality and sterility.