FDA Inspection 1254940 — Herniamesh S.R.L
The FDA completed an inspection of Herniamesh S.R.L on Nov 21, 2024 in Chivasso. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 21, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chivasso (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |