FDA Inspection 1058626 — ScandiDos AB
The FDA completed an inspection of ScandiDos AB on Jul 12, 2018 in Uppsala. 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
- Jul 12, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Uppsala (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |