FDA 483 - Avokaid, LLC - November 25, 2025

Avokaid, LLC, a specification developer and initial importer in Plano, TX, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, including a lack of established procedures for medical device reporting, complaint handling, quality audits, acceptance activities, supplier control, and corrective and preventive actions. These issues indicate a systemic failure to implement and maintain a compliant quality management system for medical devices.