FDA 483 - Surgical Innovation Associates Inc - July 13, 2021

An FDA inspection of Surgical Innovation Associates, Inc. in Libertyville, IL, conducted from July 13-15, 2021, revealed that the firm's procedures for corrective and preventive action (CAPA) were not adequately established. This included issues with mislabeled DuraSorb devices due to incorrect expiration dates and particulate matter in other devices where a root cause was not identified. The findings indicate deficiencies in the firm's quality system for addressing non-conformances.