FDA Inspection 1208817 — Samhall AB
The FDA completed an inspection of Samhall AB on June 9, 2023 in Svenstavik. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 9, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Svenstavik (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 3159 | 21 CFR 820.184 | DHR content |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 5031 | 21 CFR 1010.2(a) | Lack of certification of conformance |
| 5811 | 21 CFR 1002.30(a)(1) | Quality control procedures |