FDA Inspection 1257775 — Octapharma Plasma, Inc.
The FDA completed an inspection of Octapharma Plasma, Inc. on Dec 20, 2024 in Terre Haute, IN. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Terre Haute, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 334 | 21 CFR 640.64(e) | Aseptic method of collection, separation and return of RBCs |