FDA 483 - Datascope Corp. - June 15, 2023

Datascope Corp. in Wayne, NJ, was inspected and cited for significant deficiencies in its quality system, particularly concerning corrective and preventive actions, non-conforming product control, and medical device reporting. The firm failed to properly manage supplier corrective actions, evaluate non-conforming materials in a timely manner, and submit required initial and supplemental Medical Device Reports within regulatory timelines, with some issues linked to patient death and serious injury. This inspection highlights systemic issues in quality management and regulatory compliance.