FDA 483 - CDR SYSTEMS, INC. - August 11, 2022

An FDA inspection of CDR SYSTEMS, INC. in Calgary revealed significant deficiencies in their quality system, particularly concerning supplier management, non-conforming product control, internal audits, and design review procedures. The inspection identified a repeat observation regarding the failure to perform quality audits, indicating persistent issues with their quality management. These findings suggest a need for comprehensive corrective actions to ensure compliance with medical device regulations.