FDA 483 - Elutia Inc - December 30, 2019

AZIYO BIOLOGICS in Roswell, GA, was inspected and received a Form FDA 483 with two observations. The inspection revealed inadequate documentation of design risk analysis, specifically concerning shelf-life changes for their CorMatrix CanGaroo ECM Envelope Products, and a failure to inform customers of these changes. Additionally, the firm failed to adequately document corrective and preventive action activities related to product failures.