FDA Inspection 812889 — Hoxworth Blood Center University Of Cincinnati
The FDA completed an inspection of Hoxworth Blood Center University Of Cincinnati on Jan 7, 2013 in Fort Mitchell, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 7, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Mitchell, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |