FDA Inspection 1267663 — Western Kentucky Regional Blood Ctr
The FDA completed an inspection of Western Kentucky Regional Blood Ctr on Apr 23, 2025 in Owensboro, KY. 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
- Apr 23, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Owensboro, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 9225 | 21 CFR 606.171 | Biological product deviation report |