FDA 483 - SurGenTec, LLC - April 18, 2019

Surgentec, LLC, a medical device manufacturer in Boca Raton, FL, was inspected by the FDA, revealing significant deficiencies. The inspection identified inadequate procedures for design validation, particularly concerning packaging changes for the Graftgun Universal Graft Delivery System. Additionally, the firm's Medical Device Reporting (MDR) procedures lacked proper documentation and recordkeeping, and corrective and preventive action (CAPA) processes were not adequately established or fully implemented.