FDA Inspection
Saint Alphonsus Regional Medical CenterSaint Alphonsus Regional Medical Center – FDA Inspection, May 4, 2023
Record Details
This FDA Inspection record concerns Saint Alphonsus Regional Medical Center, with an inspection on May 4, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 81566462-2b21-40b3-9a85-2af71a9d41b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1204398
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 606.151(e)Procedures to expedite transfusions in emergencies
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.151(e)Procedures to expedite transfusions in emergencies
- 21 CFR 606.171Biological product deviation report
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Other FDA inspections of Saint Alphonsus Regional Medical Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 20, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 2, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 16, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 13, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Saint Alphonsus Regional Medical Center
- FDA Inspection 1277167 - 2025-07-18
- FDA Inspection 1028911 - 2017-09-20
- FDA Inspection 983860 - 2016-09-02
- FDA Inspection 874602 - 2014-04-16
- FDA Inspection 811103 - 2012-12-13
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