FDA 483 - Viant San Antonio, Inc. - March 19, 2026

An FDA inspection of Viant San Antonio, Inc., a manufacturer of Class II medical device tubing, revealed significant deficiencies in product realization planning. The firm failed to adequately define required activities and controls within its pFMEA, leading to unmitigated risks for potential patient harm. This was further evidenced by multiple complaints regarding leaking and hair in the tubing, which were not adequately addressed in the risk management process.