FDA 483 - MAST Biosurgery USA Inc - November 19, 2021

An FDA inspection of MAST Biosurgery USA Inc. in San Diego, CA, identified two significant observations regarding their medical device manufacturing operations. The firm failed to adequately validate a package sealing process for its SurgiWrap device, with re-qualification incomplete and required tests omitted. Additionally, procedures for corrective and preventive actions were found to be inadequately established, specifically concerning the basis for assigning risk scores to CAPAs.