FDA Inspection
3D SYSTEMS - LAYERWISE3D SYSTEMS - LAYERWISE – FDA Inspection, Jun 15, 2023
Record Details
This FDA Inspection record concerns 3D SYSTEMS - LAYERWISE, with an inspection on June 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9240d4d6-433c-49f9-b34c-5242e9a17452
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1208903
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of 3D SYSTEMS - LAYERWISE
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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