FDA 483 - 3D SYSTEMS - LAYERWISE - June 15, 2023

An FDA inspection of 3D SYSTEMS - LAYERWISE in Leuven, Belgium, identified significant deficiencies in their quality system. The firm failed to adequately establish procedures for complaint management, corrective and preventive actions (CAPA), and control of nonconforming products. These issues indicate a systemic lack of robust quality control, potentially impacting device safety and regulatory compliance.