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