FDA Inspection
Saint Elizabeth Hospital LaboratorySaint Elizabeth Hospital Laboratory – FDA Inspection, Mar 8, 2017
Record Details
This FDA Inspection record concerns Saint Elizabeth Hospital Laboratory, with an inspection on March 8, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · fe247ca2-f7f5-42a4-88a6-b576e2e1c4c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018476
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)SOPs for investigations, records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Saint Elizabeth Hospital Laboratory
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2024 | Not classified | Minneapolis District Office | |
| September 19, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 3, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Saint Elizabeth Hospital Laboratory
- FDA Inspection 1254792 - 2024-10-24
- FDA Inspection 1103270 - 2019-09-19
- FDA Inspection 908392 - 2014-12-03
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