FDA Inspection 685909 — Octapharma Plasma Inc
The FDA completed an inspection of Octapharma Plasma Inc on September 30, 2010 in Van Nuys, CA. 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) (VAI)
- End Date
- September 30, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Van Nuys, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 80 | 21 CFR 606.100(b)(1) | Donor criteria |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 9241 | 21 CFR 630.40(a) | Supplemental results |
| 9243 | 21 CFR 630.40(a) | Notification |