FDA Inspection 634606 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on Dec 8, 2009 in Melrose Park, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 8, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Melrose Park, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 343 | 21 CFR 640.65(b)(3) | Donor identification system |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |