FDA 483 - Myriad Medical, LLC - August 17, 2023

Myriad Medical, LLC in Tampa, FL, a specification developer of medical devices, received five observations during an FDA inspection. The inspection revealed significant deficiencies in quality system procedures, including inadequate supplier controls, lack of documented CAPA activities, and insufficient medical device reporting procedures. Additionally, the firm failed to conduct internal quality audits and maintain complete training records, indicating a general lack of implementation and establishment of critical quality system processes.