FDA Inspection 626883 — Herniamesh S.R.L
The FDA completed an inspection of Herniamesh S.R.L on Nov 5, 2009 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 5, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chivasso (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 2649 | 21 CFR 820.30(f) | Design verification acceptance criteria |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |