FDA Inspection 1295756 — One Blood Inc
The FDA completed an inspection of One Blood Inc on Dec 15, 2025 in Concord, NC. 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 15, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Concord, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |