FDA Inspection 914594 — HSHS St. John's Hospital
The FDA completed an inspection of HSHS St. John's Hospital on February 20, 2015 in Springfield, IL. 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 20, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Springfield, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15041 | 21 CFR 610.47(b) | Lookback System [Consignee] |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |