FDA Inspection 1305880 — Anteis Sa
The FDA completed an inspection of Anteis Sa on February 25, 2026 in Plan-Les-Ouates. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Plan-Les-Ouates (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |