FDA Inspection 1320534 — Barco N.V.
The FDA completed an inspection of Barco N.V. on Jun 5, 2026 in Kortrijk. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Kortrijk (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |