FDA Inspection 627148 — Aurora St. Luke's Medical Center
The FDA completed an inspection of Aurora St. Luke's Medical Center on October 8, 2009 in Milwaukee, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 8, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 98 | 21 CFR 606.100(c) | Thorough investigations |