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

Source: https://www.keypedia.com/records/483/3d-systems-layerwise/cb596fdf-e3ad-4d06-bbd3-a182c0ca5fdb

> FDA 483 for 3D SYSTEMS - LAYERWISE on June 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 3D SYSTEMS - LAYERWISE
- Inspection Date: 2023-06-15
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.keypedia.com/companies/3d-systems-layerwise/2e27a0fd-2fc2-4070-8648-da8a4a8b3c3a

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd