FDA 483 - Austco Marketing & Service LTD. - July 30, 2025

Austco Marketing & Service LTD. in Irving, TX was inspected by the FDA from July 28-30, 2025. The inspection revealed a significant quality system deficiency related to design control documentation. Specifically, the firm failed to properly document design review results and meeting minutes for software updates to their Tacera Nurse Call System, indicating a lack of adherence to their own procedures.