FDA 483 - Medax Srl Unipersonale - March 18, 2019

An FDA inspection of Medax Srl Unipersonale, a medical device manufacturer in San Possidonio, Italy, revealed significant deficiencies in its quality system. Observations included inadequate procedures for corrective and preventive actions, insufficient documentation of these activities, and failures in establishing procedures for non-conforming product disposition. Additionally, the firm lacked validation for a critical manufacturing process and failed to establish adequate purchasing data for received components.