FDA Inspection 1088649 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on May 2, 2019 in Philadelphia, PA. 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
- May 2, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18060 | 21 CFR 630.5(c)(1)(i) | Responsible physician not on site - SP & plasmapheresis |