FDA Inspection 1251969 — Baxalta Belgium Manufacturing SA
The FDA completed an inspection of Baxalta Belgium Manufacturing SA on Nov 22, 2024 in Lessines. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 22, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lessines (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |