FDA Inspection 1321512 — Manatec S.A.R.L.
The FDA completed an inspection of Manatec S.A.R.L. on Jun 11, 2026 in Poissy. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Poissy (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23130 | ISO 13485:2016 Clause 7.3.9 | Procedures to control design and development changes not documented |