FDA Inspection 827645 — Octapharma Plasma Inc
The FDA completed an inspection of Octapharma Plasma Inc on April 12, 2013 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Van Nuys, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 35 | 21 CFR 606.40 | Clean & orderly |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |