FDA Inspection 1311554 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on April 9, 2026 in Whitestown, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 9, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Whitestown, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3642 | 21 CFR 640.76(c) | Source Plasma - Re-labeling |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9270 | 21 CFR 610.40(h)(2)(ii) | Labeling of reactive units, units from deferred donors |