FDA 483 - Turbett Surgical, Inc. - June 26, 2023

Turbett Surgical, Inc. in Henrietta, NY, a medical device specification developer, was inspected by the FDA from June 12-26, 2023. The inspection revealed significant deficiencies in their quality system, particularly concerning design controls, validation processes, corrective and preventive actions, and complaint handling. Several observations were repeats from a previous inspection, indicating persistent issues that could impact device safety and effectiveness.