FDA Inspection
Barco N.V.Barco N.V. – FDA Inspection, Sep 14, 2023
Record Details
This FDA Inspection record concerns Barco N.V., with an inspection on September 14, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 75535ecb-1824-45d5-97fd-439534a154fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220423
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
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Other FDA inspections of Barco N.V.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| September 21, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Barco N.V.
- FDA Inspection 1320534 - 2026-06-05
- FDA Inspection 1070447 - 2018-09-21
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