FDA Inspection 673323 — Western Kentucky Regional Blood Ctr
The FDA completed an inspection of Western Kentucky Regional Blood Ctr on July 22, 2010 in Hopkinsville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 22, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hopkinsville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |