FDA Inspection 1049680 — Stanford Blood Center
The FDA completed an inspection of Stanford Blood Center on Apr 24, 2018 in Palo Alto, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 24, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Palo Alto, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18039 | 21 CFR 606.100(b)(22) | Control risk of bacterial contamination of platelets |
| 18049 | 21 CFR 606.145(b) | Release of contaminated product |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 80 | 21 CFR 606.100(b)(1) | Donor criteria |