FDA Inspection
Aurora Health Care - Aurora Fertility ServicesAurora Health Care - Aurora Fertility Services – FDA Inspection, Feb 13, 2017
Record Details
This FDA Inspection record concerns Aurora Health Care - Aurora Fertility Services, with an inspection on February 13, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 13, 2017
- Product Type
- Biologics
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ID · 8547f1f3-2d53-4cd9-b702-254706bd75e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007440
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.47(d)Departures: recording and justifying
- 21 CFR 1271.75(e)Abbreviated procedure
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Aurora Health Care - Aurora Fertility Services
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2025 | Not classified | Minneapolis District Office | |
| December 11, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 21, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 28, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 8, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Aurora Health Care - Aurora Fertility Services
- FDA Inspection 1280919 - 2025-08-21
- FDA Inspection 1114703 - 2019-12-11
- FDA Inspection 946209 - 2015-09-21
- FDA Inspection 808565 - 2012-11-28
- FDA Inspection 712866 - 2011-03-08
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