FDA Inspection
Fertility and Advanced Reproductive Medicine at UTSWFertility and Advanced Reproductive Medicine at UTSW – FDA Inspection, Dec 13, 2023
Record Details
This FDA Inspection record concerns Fertility and Advanced Reproductive Medicine at UTSW, with an inspection on December 13, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 13, 2023
- Product Type
- Biologics
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ID · c208b827-f026-4ad2-9112-9f701147d7cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224882
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
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Other FDA inspections of Fertility and Advanced Reproductive Medicine at UTSW
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 17, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 14, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 20, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Fertility and Advanced Reproductive Medicine at UTSW
- FDA Inspection 1077600 - 2018-11-08
- FDA Inspection 930747 - 2015-05-17
- FDA Inspection 781377 - 2012-05-14
- FDA Inspection 564477 - 2009-02-20
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