FDA Inspection 1054641 — DiaSource ImmunoAssays, SA
The FDA completed an inspection of DiaSource ImmunoAssays, SA on Jun 7, 2018 in Louvain-La-Neuve. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 7, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Louvain-La-Neuve (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |