FDA Inspection
OU Health Reproductive Medicine LabOU Health Reproductive Medicine Lab – FDA Inspection, Jun 21, 2017
Record Details
This FDA Inspection record concerns OU Health Reproductive Medicine Lab, with an inspection on June 21, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 890ab035-2b22-40c0-819a-c36d1d9460d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015881
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OU Health Reproductive Medicine Lab
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2025 | NAI | Human Cellular, Tissue, and Gene Therapies | |
| April 18, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 28, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 16, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for OU Health Reproductive Medicine Lab
- FDA Inspection 1273031 - 2025-06-10
- FDA Inspection 1170087 - 2022-04-18
- FDA Inspection 825851 - 2013-03-28
- FDA Inspection 702403 - 2010-11-16
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