FDA Inspection
Materialise N.V.Materialise N.V. – FDA Inspection, Mar 13, 2025
Record Details
This FDA Inspection record concerns Materialise N.V., with an inspection on March 13, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 59574c78-1c2a-41dc-9422-a5538b73845c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1264936
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Materialise N.V.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Materialise N.V.
- FDA Inspection 1003668 - 2017-02-02
- FDA Inspection 868332 - 2014-02-06
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