FDA 483 - Datascope Corp. - January 21, 2022

Datascope Corp. in Wayne, NJ, was inspected by the FDA from November 2021 to January 2022, resulting in 13 observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, risk management, design validation and verification, supplier controls, complaint handling, equipment calibration, and timely Medical Device Report (MDR) submissions for deaths and malfunctions. Several observations were repeats, indicating persistent issues with the firm's quality management system for its Cardiosave IABP devices.