FDA Inspection 820163 — University of Wisconsin Hospitals & Clinics Authority
The FDA completed an inspection of University of Wisconsin Hospitals & Clinics Authority on February 28, 2013 in Madison, WI. 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
- February 28, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Madison, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |