FDA Inspection 669606 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on June 16, 2010 in Evansville, IN. 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
- June 16, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Evansville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9089 | 21 CFR 600.14(c) | When to report |
| 9241 | 21 CFR 630.40(a) | Supplemental results |