FDA Inspection
Froedtert Hospital Reproductive Medicine CenterFroedtert Hospital Reproductive Medicine Center – FDA Inspection, Jan 11, 2012
Record Details
This FDA Inspection record concerns Froedtert Hospital Reproductive Medicine Center, with an inspection on January 11, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 11, 2012
- Product Type
- Biologics
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ID · dceb2680-2b4a-4846-8225-66c873ecda22
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 763041
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.90(c)Eligibility not required--warning labels
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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 |
| December 8, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 8, 2013 | NAI | 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 954292 - 2015-12-08
- FDA Inspection 855185 - 2013-11-08
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