FDA Inspection 730020 — Moor Instruments Ltd
The FDA completed an inspection of Moor Instruments Ltd on May 6, 2011 in Axminster. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 6, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Axminster (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |