FDA 483 - XCATH INC - October 26, 2021

An FDA inspection of XCATH INC in Houston, TX, a medical device manufacturer, revealed significant deficiencies in its design control processes. The firm failed to adequately verify design outputs against inputs, did not properly translate device designs into production specifications, and lacked established procedures for comprehensive design reviews, particularly involving all contract manufacturers. These issues indicate a breakdown in the quality system for the (b)(4) Guidewire System.