FDA Inspection 1255245 — Stanford Blood Center
The FDA completed an inspection of Stanford Blood Center on Nov 26, 2024 in Palo Alto, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 26, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Palo Alto, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |