FDA Inspection 1120806 — MatOrtho Ltd
The FDA completed an inspection of MatOrtho Ltd on March 5, 2020 in Leatherhead. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Leatherhead (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |