FDA Inspection 1259407 — GenIbet Biopharmaceuticals, S.A.
The FDA completed an inspection of GenIbet Biopharmaceuticals, S.A. on Jan 21, 2025 in Oeiras. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 21, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Oeiras (Portugal)
Citations
| ID | CFR | Description |
|---|---|---|
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |