FDA Inspection
Versiti Blood Health, IncVersiti Blood Health, Inc – FDA Inspection, Sep 30, 2024
Record Details
This FDA Inspection record concerns Versiti Blood Health, Inc, with an inspection on September 30, 2024, issued by the Detroit District Office, covering biologics.
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ID · 173e29f8-db1d-4aa9-957a-38122a4cbb98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1250587
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.200(a)Cleaned, sanitized per established schedules
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Versiti Blood Health, Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2026 | Not classified | Detroit District Office | Human Cellular, Tissue, and Gene Therapies |
| 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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