FDA Inspection
Froedtert Hospital Reproductive Medicine CenterFroedtert Hospital Reproductive Medicine Center – FDA Inspection, Dec 8, 2015
Record Details
This FDA Inspection record concerns Froedtert Hospital Reproductive Medicine Center, with an inspection on December 8, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 8, 2015
- Product Type
- Biologics
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ID · 16d59606-66c3-4f56-9e6f-d87dd013a94c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 954292
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 1271.65(a)Improper release prevention--storage, I.D.
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Other FDA inspections of Froedtert Hospital Reproductive Medicine Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | Not classified | Minneapolis District Office | |
| December 9, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 7, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 8, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 11, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Froedtert Hospital Reproductive Medicine Center
- FDA Inspection 1281234 - 2025-08-22
- FDA Inspection 1114305 - 2019-12-09
- FDA Inspection 1035873 - 2017-12-07
- FDA Inspection 855185 - 2013-11-08
- FDA Inspection 763041 - 2012-01-11
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