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