FDA 483 - Santanello Surgical LLC - June 07, 2019

An FDA inspection of Santanello Surgical LLC in Columbus, OH, from May 30 to June 7, 2019, revealed significant deficiencies in the firm's quality system. The inspection found that the medical device manufacturer had not established numerous critical procedures, including those for design control, purchasing, corrective and preventive actions, complaint handling, and device record management. These widespread procedural failures indicate a fundamental lack of a compliant quality system.