FDA 483 - Datascope Corp. - October 03, 2018

Datascope Corp. in Mahwah, NJ, a manufacturer of Cardiosave Intra-Aortic Balloon Pumps, was cited for significant deficiencies across its quality system during an FDA inspection. Observations included failures in establishing and executing procedures for design validation, design change, design verification, corrective and preventive actions, supplier management, and maintaining adequate device history records. The firm also failed to ensure proper review and approval of documents.