FDA Inspection 1270455 — Octapharma Plasma Inc.
The FDA completed an inspection of Octapharma Plasma Inc. on Jun 5, 2025 in Sparks, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 5, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sparks, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18070 | 21 CFR 630.10(a) | Donor Eligibility Factors |
| 81 | 21 CFR 606.100(b)(2) | Donor qualifying tests & measurements |