FDA Inspection 1117599 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on Feb 12, 2020 in New Hope, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 12, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New Hope, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18074 | 21 CFR 630.10(c) | Donor Eligibility on day of donation |
| 9225 | 21 CFR 606.171 | Biological product deviation report |