FDA 483 - Argon Medical Devices, Inc - March 19, 2024

An FDA inspection of Argon Medical Devices, Inc. in Athens, TX, revealed significant deficiencies in its quality system. The firm failed to adequately investigate customer complaints regarding device failures, particularly repeated issues with guidewires, and did not consistently evaluate complaints for MDR reportability. Additionally, personnel training records were found to be incomplete and not readily available, indicating a lack of proper documentation for employee training.