FDA Inspection
Stanford Blood CenterStanford Blood Center – FDA Inspection, Apr 24, 2018
Record Details
This FDA Inspection record concerns Stanford Blood Center, with an inspection on April 24, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d5901c05-e998-4b07-a07a-0e52551f0ee3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1049680
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 606.100(b)(1)Donor criteria
- 21 CFR 606.100(b)(22)Control risk of bacterial contamination of platelets
- 21 CFR 606.145(b)Release of contaminated product
- 21 CFR 606.65(e)Following manufacturer's instructions
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Other FDA inspections of Stanford Blood Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 26, 2024 | VAI | San Francisco District Office | Blood and Blood Products |
| July 10, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 18, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 14, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Stanford Blood Center
- FDA Inspection 1266066 - 2025-03-28
- FDA Inspection 1255245 - 2024-11-26
- FDA Inspection 934133 - 2015-07-10
- FDA Inspection 814918 - 2013-01-18
- FDA Inspection 695091 - 2010-10-14
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