FDA Inspection 605487 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on August 14, 2009 in Omaha, NE. 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
- August 14, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |