FDA Inspection 669759 — Csl Plasma
The FDA completed an inspection of Csl Plasma on Jul 9, 2010 in Columbus, OH. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 9, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Columbus, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3244 | 21 CFR 640.61 | Written consent |
| 325 | 21 CFR 640.63(c)(10) | Narcotics use |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |