FDA Inspection
Versiti Blood Health, IncVersiti Blood Health, Inc – FDA Inspection, Jun 19, 2009
Record Details
This FDA Inspection record concerns Versiti Blood Health, Inc, with an inspection on June 19, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Versiti Blood Health, Inc
- Inspection Date
- June 19, 2009
- Product Type
- Biologics
View Company Profile
ID · cbd30543-dd46-427d-88ca-53613f9f3ad9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 594930
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 606.171Biological product deviation report
- 21 CFR 601.12(c)Moderate changes to an approved application
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
- 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 |
| 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 |
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