FDA 483 - Thompson Ocular Prosthetics, Inc - July 02, 2025

Thompson Ocular Prosthetics, Inc. in San Antonio, TX, was inspected regarding its manufacturing of Class II medical devices. The inspection revealed significant and systemic failures in their quality management system, including repeat observations from a previous 2021 inspection. Key issues involved inadequate design controls, corrective and preventive actions, complaint handling, quality audits, management review procedures, and personnel training.