FDA 483 - Vista Lifesciences, Inc. - November 04, 2025

An FDA inspection of Vista Lifesciences, Inc., a medical device manufacturer in Englewood, CO, revealed significant deficiencies in their quality system. The firm's corrective and preventive action (CAPA) procedures were not adequately established. This included failures to document root cause investigations and to ensure effectiveness checks verified that corrective actions addressed the original root causes of non-conformities.