FDA Inspection 750627 — Octapharma Plasma Donation Center-Aurora
The FDA completed an inspection of Octapharma Plasma Donation Center-Aurora on October 24, 2011 in Aurora, IL. 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
- October 24, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Aurora, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 9236 | 21 CFR 630.40(b)(1) | Deferred or not eligible |