FDA Inspection
Barco N.V.Barco N.V. – FDA Inspection, Jun 5, 2026
Record Details
This FDA Inspection record concerns Barco N.V., with an inspection on June 5, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · ee9999b6-bc78-4c2d-aae0-cc33506b51c8
Inspection Facts
- Inspection number
- 1320534
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Barco N.V.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 21, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Barco N.V.
- FDA Inspection 1220423 - 2023-09-14
- FDA Inspection 1070447 - 2018-09-21
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