FDA Inspection 1098763 — Evanston Hospital Blood Bank
The FDA completed an inspection of Evanston Hospital Blood Bank on August 6, 2019 in Evanston, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 6, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Evanston, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12373 | 21 CFR 1271.200(d) | Inspected routinely |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |