FDA Inspection 980879 — Sportarredo Group S. C.
The FDA completed an inspection of Sportarredo Group S. C. on Jul 22, 2016 in Gruaro. 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). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 22, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gruaro (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 5813 | 21 CFR 1002.30(a)(2) | Methods, devices, procedures for testing |