FDA 483 - Ensitevascular LLC - November 06, 2024

An FDA inspection of Ensitevascular LLC in Overland Park, KS, a specification developer for the Class II SiteSeal device, revealed significant deficiencies in their quality system. The firm failed to establish procedures and perform activities related to design control, supplier evaluation, and internal quality audits. These issues indicate a fundamental lack of a robust quality management system for a distributed medical device.