FDA Inspection 627148 — Aurora St. Luke's Medical Center
The FDA completed an inspection of Aurora St. Luke's Medical Center on Oct 8, 2009 in Milwaukee, WI. 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
- Oct 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 |