FDA Inspection 857691 — Advocate Lutheran General Hospital Blood Bank
The FDA completed an inspection of Advocate Lutheran General Hospital Blood Bank on December 9, 2013 in Park Ridge, 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
- December 9, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Park Ridge, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |