FDA Inspection 1293312 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on December 1, 2025 in District Heights, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 1, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- District Heights, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18118 | 21 CFR 630.30(b)(1) | Unsuitable donation - release |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |