FDA Inspection
Versiti Blood Health, IncVersiti Blood Health, Inc – FDA Inspection, Mar 17, 2017
Record Details
This FDA Inspection record concerns Versiti Blood Health, Inc, with an inspection on March 17, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Brittany M. Lowe (Issuing Officer)
- Lewis K. Antwi (Issuing Officer)
- Travis S. Bradley (FDA Associated Person)
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ID · 05bac6ae-e9d2-4bc7-8495-8679af5d0843
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007580
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.100(c)Thorough investigations
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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 |
| May 7, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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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