FDA 483 - Saint-Gobain Perofrmance Plastics, Inc. - July 28, 2023

An FDA inspection of Saint-Gobain Performance Plastics, Inc. in Portage, WI, from July 24-28, 2023, revealed a significant deficiency in the firm's quality system. The company's corrective and preventive action (CAPA) procedures were found to be inadequately established, specifically lacking provisions to ensure the effectiveness of implemented actions and to prevent adverse effects on finished devices. This indicates a moderate severity issue related to quality system controls for medical device manufacturing.