FDA Inspection 858681 — Aurora St. Luke's Medical Center
The FDA completed an inspection of Aurora St. Luke's Medical Center on Dec 9, 2013 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 9, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |