FDA Inspection 563389 — Medibo N.V.
The FDA completed an inspection of Medibo N.V. on Jan 22, 2009 in Hamont-Achel. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 22, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hamont-Achel (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |