FDA Inspection
3D SYSTEMS - LAYERWISE3D SYSTEMS - LAYERWISE – FDA Inspection, Apr 6, 2017
Record Details
This FDA Inspection record concerns 3D SYSTEMS - LAYERWISE, with an inspection on April 6, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Marc S. Neubauer (Issuing Officer)
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ID · e5dbec02-0332-4e2e-978f-21f888ffbb60
Inspection Facts
- Inspection number
- 1008832
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of 3D SYSTEMS - LAYERWISE
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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