FDA 483 - Datascope Corp. - June 15, 2023

Datascope Corp. in Wayne, NJ, a medical device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, control non-conforming products, accept incoming products, and use valid statistical techniques. Additionally, the company repeatedly failed to submit timely Medical Device Reports (MDRs) for device malfunctions, including those linked to patient death and serious injury, indicating severe non-compliance with regulatory reporting requirements.