FDA Inspection 1151402 — Octapharma Plasma Inc
The FDA completed an inspection of Octapharma Plasma Inc on September 10, 2021 in Columbus, OH. 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 10, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Columbus, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18068 | 21 CFR 630.5(d) | CPR certification |
| 18113 | 21 CFR 630.30(a) | Donation suitability |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |