FDA Inspection 1274807 — Hendrick Regional Blood Center
The FDA completed an inspection of Hendrick Regional Blood Center on Jun 27, 2025 in Abilene, TX. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 27, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Abilene, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 110 | 21 CFR 606.120(b)(2) | Destruction of obsolete labels |
| 18082 | 21 CFR 630.10(e)(2) | Additional Medical Assessment Factors |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |