FDA 483 - Myriad Medical, LLC - October 17, 2019

An FDA inspection of Myriad Medical Llc, a medical device manufacturer in Tampa, FL, revealed significant deficiencies in their quality system. The firm failed to establish and implement adequate procedures for corrective and preventive actions, complaint handling, medical device reporting, supplier controls, and quality audits. Additionally, the design history file for their Prostate Caddy device lacked necessary validation and verification records, indicating a broad lack of compliance with regulatory requirements.