FDA Inspection
Fertility Wellness Institute of OhioFertility Wellness Institute of Ohio – FDA Inspection, Aug 18, 2023
Record Details
This FDA Inspection record concerns Fertility Wellness Institute of Ohio, with an inspection on August 18, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · ee041a09-f21b-442a-805f-66775a1a5a96
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215670
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fertility Wellness Institute of Ohio
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2025 | Not classified | Cincinnati District Office | |
| September 16, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 19, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 28, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Fertility Wellness Institute of Ohio
- FDA Inspection 1278803 - 2025-08-18
- FDA Inspection 1102208 - 2019-09-16
- FDA Inspection 1012203 - 2017-05-19
- FDA Inspection 911673 - 2015-01-28
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