1064322
Osteotec Limited — FEI 3008395366
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 4, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Christchurch (United Kingdom)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |