FDA Inspection 1277876 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on August 7, 2025 in Grand Junction, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Grand Junction, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9223 | 21 CFR 606.160(b)(6) | Required records - transfusion reaction and complaints |