FDA Inspection
Altru Health SystemsAltru Health Systems – FDA Inspection, May 20, 2025
Record Details
This FDA Inspection record concerns Altru Health Systems, with an inspection on May 20, 2025, issued by the Minneapolis District Office, covering biologics.
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ID · b755321a-15be-44e9-b323-0caf8fc8513e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1270287
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
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Other FDA inspections of Altru Health Systems
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 8, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 31, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 7, 2016 | 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 Systems
- FDA Inspection 1179017 - 2022-08-05
- FDA Inspection 1100020 - 2019-08-08
- FDA Inspection 1094264 - 2019-05-31
- FDA Inspection 967556 - 2016-04-07
- FDA Inspection 880864 - 2014-05-06
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