FDA Inspection 962748 — Aurora St. Luke's Medical Center
The FDA completed an inspection of Aurora St. Luke's Medical Center on March 23, 2016 in Milwaukee, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |