FDA 483 - AutoMedx, LLC - January 18, 2024

AutoMedx, LLC, a specification developer in Addison, TX, was cited for significant deficiencies in its quality system during an FDA inspection from January 9-18, 2024. The inspection revealed failures in complaint handling, supplier controls, internal quality audits, and management review procedures, with several issues being repeat observations. These findings indicate a systemic lack of adherence to established quality system requirements.