FDA Inspection 1177362 — Medivance Instruments Ltd.
The FDA completed an inspection of Medivance Instruments Ltd. on Aug 11, 2022 in London. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 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 |