FDA Inspection 842242 — Advocate Christ Medical Center Transfusion Services
The FDA completed an inspection of Advocate Christ Medical Center Transfusion Services on August 6, 2013 in Oak Lawn, 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
- August 6, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Oak Lawn, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 155 | 21 CFR 606.160(b) | Required records |