FDA Inspection
Saint Alphonsus Regional Medical CenterSaint Alphonsus Regional Medical Center – FDA Inspection, Sep 2, 2016
Record Details
This FDA Inspection record concerns Saint Alphonsus Regional Medical Center, with an inspection on September 2, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 2, 2016
- Product Type
- Biologics
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ID · 67be862d-c7b5-4848-b21b-6ef0f9506620
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983860
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| May 4, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 20, 2017 | NAI | 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 1204398 - 2023-05-04
- FDA Inspection 1028911 - 2017-09-20
- FDA Inspection 874602 - 2014-04-16
- FDA Inspection 811103 - 2012-12-13
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