FDA Inspection 772051 — Western Kentucky Regional Blood Ctr
The FDA completed an inspection of Western Kentucky Regional Blood Ctr on Mar 9, 2012 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
- Mar 9, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Owensboro, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |