FDA Inspection
Altru Health SystemAltru Health System – FDA Inspection, Apr 7, 2016
Record Details
This FDA Inspection record concerns Altru Health System, with an inspection on April 7, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Altru Health System
- Inspection Date
- April 7, 2016
- Product Type
- Biologics
View Company Profile
ID · 6b637c9b-a5ac-4052-a76a-581c61492229
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967558
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Altru Health System
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2025 | VAI | Minneapolis District Office | Blood and Blood Products |
| June 2, 2022 | NAI | 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 1269751 - 2025-05-16
- FDA Inspection 1173275 - 2022-06-02
- FDA Inspection 880868 - 2014-05-06
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