FDA 483 - Alcon Research, LLC - April 25, 2023

An FDA inspection of Alcon Research, LLC in Irvine, CA, a medical device manufacturer, identified a significant deficiency in their corrective and preventive action (CAPA) system. The firm closed a CAPA related to nonconforming raw material (flash drive data for a component) without conducting an effectiveness check or verifying that the corrective action adequately addressed the root cause. This lapse is concerning as the risk management report indicates a possible patient risk of retinal detachment.