FDA Inspection 865140 — Western Kentucky Regional Blood Ctr
The FDA completed an inspection of Western Kentucky Regional Blood Ctr on Jan 14, 2014 in Hopkinsville, 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 14, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hopkinsville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 35 | 21 CFR 606.40 | Clean & orderly |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |