FDA Inspection 1275015 — Medtech SAS
The FDA completed an inspection of Medtech SAS on Jul 24, 2025 in Mauguio. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 24, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mauguio (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 21443 | 21 CFR 803.52(e)(5) | PMA/510(k) number, combination product information |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 738 | 21 CFR 803.52(a)(1) | Patient Name or Other Identifier |