FDA Inspection
Innovis Health, LLCInnovis Health, LLC – FDA Inspection, Jun 11, 2025
Record Details
This FDA Inspection record concerns Innovis Health, LLC, with an inspection on June 11, 2025, issued by the Minneapolis District Office, covering biologics.
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ID · 1d3a5d6f-c64f-4cbe-bd44-3e2fc3c00564
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1272398
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.160(b)Required records
- 21 CFR 606.171Biological product deviation report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Innovis Health, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 23, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 5, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 25, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Innovis Health, LLC
- FDA Inspection 1172044 - 2022-05-25
- FDA Inspection 1049430 - 2018-03-23
- FDA Inspection 971398 - 2016-05-05
- FDA Inspection 884536 - 2014-06-25
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