FDA Inspection 937481 — Herniamesh S.R.L
The FDA completed an inspection of Herniamesh S.R.L on Jul 23, 2015 in Chivasso. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 23, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chivasso (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |