FDA Inspection 1047540 — EDAP - TMS France SA
The FDA completed an inspection of EDAP - TMS France SA on Mar 22, 2018 in Vaulx En Velin. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 22, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Vaulx En Velin (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |