FDA 483 - US Vascular, Inc. - March 30, 2018

US Vascular LLC in Beaverton, OR, a medical device manufacturer, was inspected by the FDA and received a Form 483 with 12 observations. The inspection revealed significant deficiencies across its quality system, including a lack of established procedures for design control, purchasing, acceptance activities, nonconforming product, CAPA, complaint handling, document control, device master records, device history records, quality audits, and MDRs. These findings indicate a fundamental absence of a compliant quality management system for medical device manufacturing.