FDA Inspection 1004971 — Optos, PLC
The FDA completed an inspection of Optos, PLC on Jan 26, 2017 in Dunfermline. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dunfermline (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |