FDA Inspection 920586 — Octapharma Plasma Inc
The FDA completed an inspection of Octapharma Plasma Inc on April 1, 2015 in Sioux City, IA. 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
- April 1, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sioux City, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |