FDA 483 - Med-Dyne, Inc. - January 30, 2023

Med-Dyne, Inc. in Louisville, KY, was inspected by the FDA from January 23-30, 2023. The inspection revealed a significant deficiency in the firm's Medical Device Reporting (MDR) procedures. Specifically, the company's written procedures lacked an internal system for timely identification and monitoring of events subject to reporting requirements, including externally submitted adverse event reports.