FDA 483 - Avokaid, LLC - November 25, 2025

Avokaid, LLC, a specification developer and initial importer of Class II medical devices in Plano, TX, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed a comprehensive lack of established procedures for critical areas such as Medical Device Reporting (MDR), complaint handling, quality audits, acceptance activities, supplier control, and corrective and preventive actions. These findings indicate a broad failure to implement essential quality system requirements for medical device operations.