FDA Inspection
Vios Fertility InstituteVios Fertility Institute – FDA Inspection, Aug 12, 2013
Record Details
This FDA Inspection record concerns Vios Fertility Institute, with an inspection on August 12, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vios Fertility Institute
- Inspection Date
- August 12, 2013
- Product Type
- Biologics
View Company Profile
ID · 369a679a-157f-47cc-9d81-99e018b1f8c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 847670
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vios Fertility Institute
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 14, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 16, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Vios Fertility Institute
- FDA Inspection 1192741 - 2022-11-02
- FDA Inspection 1028518 - 2017-09-14
- FDA Inspection 958136 - 2015-12-16
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