FDA Inspection 1110355 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on November 18, 2019 in Jackson, MS. 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
- November 18, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Jackson, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 106 | 21 CFR 606.120(a) | Separation of labeling operations |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |