FDA Inspection
Versiti Blood Health, IncVersiti Blood Health, Inc – FDA Inspection, May 7, 2019
Record Details
This FDA Inspection record concerns Versiti Blood Health, Inc, with an inspection on May 7, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 3f0ea0af-9dba-45e7-9aa2-9e76d360994d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1088787
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 1271.200(a)Cleaned, sanitized per established schedules
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 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 |
| September 30, 2024 | VAI | Detroit District Office | Blood and Blood Products |
| 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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