FDA Inspection
Elite IVF & Fertility Solutions LLCElite IVF & Fertility Solutions LLC – FDA Inspection, Jul 13, 2023
Record Details
This FDA Inspection record concerns Elite IVF & Fertility Solutions LLC, with an inspection on July 13, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 8f3a2c0f-53e5-4012-9994-c1150c7f1e79
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1209972
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
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Other FDA inspections of Elite IVF & Fertility Solutions LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | VAI | Dallas District Office | Human Cellular, Tissue, and Gene Therapies |
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