FDA Inspection
SSM Health St. Mary's Hospital - MadisonSSM Health St. Mary's Hospital - Madison – FDA Inspection, Jul 20, 2017
Record Details
This FDA Inspection record concerns SSM Health St. Mary's Hospital - Madison, with an inspection on July 20, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · eefc239d-3da9-4a0d-8e98-1d422ec7e8b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018527
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of SSM Health St. Mary's Hospital - Madison
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 19, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 22, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for SSM Health St. Mary's Hospital - Madison
- FDA Inspection 1244367 - 2024-07-16
- FDA Inspection 1080697 - 2019-02-19
- FDA Inspection 914333 - 2015-01-22
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