FDA Inspection
Versiti Blood Health, IncVersiti Blood Health, Inc – FDA Inspection, Aug 18, 2026
Record Details
This FDA Inspection record concerns Versiti Blood Health, Inc, with an inspection on August 18, 2026, issued by the Detroit District Office, covering biologics.
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ID · 9814b256-358c-46d4-b9ec-99f36d81acbb
Inspection Facts
- Inspection number
- 1325858
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
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Other FDA inspections of Versiti Blood Health, Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2024 | VAI | Detroit District Office | Blood and Blood Products |
| May 7, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 17, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 25, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 19, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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