FDA Inspection 1118835 — Mi3 Limited
The FDA completed an inspection of Mi3 Limited on February 6, 2020 in Blackburn. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 6, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Blackburn (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |