FDA Inspection 916423 — Octapharma Plasma Inc
The FDA completed an inspection of Octapharma Plasma Inc on March 4, 2015 in Omaha, NE. 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
- March 4, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |