FDA Inspection
Inovi Fertility and Genetics InstituteInovi Fertility and Genetics Institute – FDA Inspection, Feb 2, 2026
Record Details
This FDA Inspection record concerns Inovi Fertility and Genetics Institute, with an inspection on February 2, 2026, issued by the Dallas District Office, covering biologics.
- Office
- Dallas District Office
- People
- Ashleigh M. Robertson (Issuing Officer)
- Elyshia Q. Danaher (Issuing Officer)
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ID · 4e37c066-78e0-4c32-a6a9-5daca27ae094
Inspection Facts
- Inspection number
- 1300844
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.90(c)Eligibility not required--warning labels
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Other FDA inspections of Inovi Fertility and Genetics Institute
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Inovi Fertility and Genetics Institute
- FDA Inspection 1140457 - 2021-04-05
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