FDA Inspection
Altru Health SystemAltru Health System – FDA Inspection, May 16, 2025
Record Details
This FDA Inspection record concerns Altru Health System, with an inspection on May 16, 2025, issued by the Minneapolis District Office, covering biologics.
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ID · cd0c4ab4-4e98-4865-9bd1-753be3509f19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269751
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.171Biological product deviation report
- 21 CFR 630.10(e)(1)Medical Assessment Factors
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Altru Health System
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 7, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 6, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Altru Health System
- FDA Inspection 1173275 - 2022-06-02
- FDA Inspection 967558 - 2016-04-07
- FDA Inspection 880868 - 2014-05-06
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