FDA 483 - AutoMedx, LLC - January 24, 2020

Auto-Medx, LLC, a medical device manufacturer in Plano, TX, was inspected by the FDA from January 21-24, 2020. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive actions, supplier control, and internal quality audits. The firm failed to establish and follow its own procedures, leading to inadequate documentation and oversight in critical areas.