FDA Inspection 840133 — Kentucky Blood Center Inc
The FDA completed an inspection of Kentucky Blood Center Inc on July 12, 2013 in Lexington, 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
- July 12, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lexington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |