FDA Inspection
Mayo Clinic Rochester, Division of Transfusion MedicineMayo Clinic Rochester, Division of Transfusion Medicine – FDA Inspection, Feb 1, 2010
Record Details
This FDA Inspection record concerns Mayo Clinic Rochester, Division of Transfusion Medicine, with an inspection on February 1, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 1, 2010
- Product Type
- Biologics
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ID · 7b33da1d-07a0-4af9-9068-b31c40106f41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 649956
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Mayo Clinic Rochester, Division of Transfusion Medicine
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 15, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 1, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 2, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 25, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Mayo Clinic Rochester, Division of Transfusion Medicine
- FDA Inspection 1286320 - 2025-09-17
- FDA Inspection 1225980 - 2023-11-15
- FDA Inspection 1073614 - 2018-11-01
- FDA Inspection 994642 - 2016-11-02
- FDA Inspection 934199 - 2015-06-25
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