FDA Inspection
Stanford Health Care Transfusion ServiceStanford Health Care Transfusion Service – FDA Inspection, May 8, 2009
Record Details
This FDA Inspection record concerns Stanford Health Care Transfusion Service, with an inspection on May 8, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 8, 2009
- Product Type
- Biologics
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ID · 5efa1437-9ac1-43f4-b0fc-a8f701b43462
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579026
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Stanford Health Care Transfusion Service
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 20, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 26, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 17, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 14, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Stanford Health Care Transfusion Service
- FDA Inspection 1267046 - 2025-03-25
- FDA Inspection 1067664 - 2018-09-20
- FDA Inspection 983868 - 2016-07-26
- FDA Inspection 874536 - 2014-04-17
- FDA Inspection 798994 - 2012-09-14
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