FDA 483 - Qlarity Imaging - September 27, 2021

An FDA inspection of Qlarity Imaging, a device manufacturer in Chicago, revealed significant deficiencies in the firm's quality system. The inspection found that procedures for Corrective and Preventive Actions (CAPA) were not adequately established, with multiple instances of incomplete documentation for non-conformances, risk assessments, and verification of effectiveness. Additionally, the firm failed to ensure that personnel, specifically the Director of Customer Success, had documented qualifications for critical responsibilities such as CAPA system management, MDR reporting, and product installation.