FDA Inspection
Versiti Michigan IncVersiti Michigan Inc – FDA Inspection, Sep 15, 2016
Record Details
This FDA Inspection record concerns Versiti Michigan Inc, with an inspection on September 15, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Versiti Michigan Inc
- Inspection Date
- September 15, 2016
- Product Type
- Biologics
View Company Profile
ID · 5101f45c-1e13-49b1-b50f-7a456b43c8f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 984353
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Versiti Michigan Inc
9| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 31, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 27, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 4, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 22, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Versiti Michigan Inc
- FDA Inspection 1268288 - 2025-04-08
- FDA Inspection 1267042 - 2025-03-31
- FDA Inspection 1245903 - 2024-06-27
- FDA Inspection 1130510 - 2020-09-04
- FDA Inspection 1066073 - 2018-08-22
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