FDA 483 - Avanos Medical, Inc. - December 15, 2023

An FDA inspection of Avanos Medical, Inc. in Alpharetta, GA, a specification developer, revealed significant deficiencies in its quality system, particularly concerning corrective and preventive actions, risk analysis, and complaint handling. The firm failed to adequately investigate root causes for adverse events, including those leading to Class I recalls for its CORTRAK 2 Enteral Access System and BALLARD ACCESS Closed Suction System, and did not maintain adequate risk analyses or complaint investigation documentation. These issues indicate a systemic breakdown in ensuring product safety and quality.