1177362
Medivance Instruments Ltd. — FEI 3003982003
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 11, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- London (United Kingdom)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |