FDA Inspection 1267663 — Western Kentucky Regional Blood Ctr
The FDA completed an inspection of Western Kentucky Regional Blood Ctr on April 23, 2025 in Owensboro, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 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 |