FDA Inspection 1239622 — FinVector Oy
The FDA completed an inspection of FinVector Oy on May 28, 2024 in Kuopio. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 28, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Kuopio (Finland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |