FDA Inspection 1266290 — LEVO AG
The FDA completed an inspection of LEVO AG on April 9, 2025 in Wohlen Ag. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 9, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wohlen Ag (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |