FDA 483 - Arctic Biomaterials Oy (ABM) - November 17, 2022

Arctic Biomaterials Oy (ABM), a Class II device manufacturer in Tampere, Finland, was inspected by the FDA from November 15-17, 2022. The inspection revealed two significant observations related to inadequate quality system procedures. Specifically, the firm failed to adequately establish procedures for the disposition of nonconforming products and for management review meetings.