FDA Inspection 843959 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on June 25, 2013 in Aurora, CO. 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
- June 25, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 371 | 21 CFR 640.72(a)(3) | Donor consent |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |