FDA 483 - US Vascular, Inc. - March 06, 2024

US Vascular, Inc. in Beaverton, OR, a manufacturer of Class 2 medical devices, was cited for three observations during an FDA inspection. The firm failed to establish procedures for design changes and corrective and preventive actions, and did not adequately maintain its device master record for the VascuLab LV40xx series. These issues indicate deficiencies in the firm's quality system for medical device manufacturing.