483
3D SYSTEMS - LAYERWISE3D SYSTEMS - LAYERWISE – FDA 483, Jun 15, 2023
Record Details
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.
View Company Profile
ID · cb596fdf-e3ad-4d06-bbd3-a182c0ca5fdb
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.