FDA Inspection
Conceive Fertility CenterConceive Fertility Center – FDA Inspection, Jun 13, 2025
Record Details
This FDA Inspection record concerns Conceive Fertility Center, with an inspection on June 13, 2025, issued by the Dallas District Office, covering biologics.
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ID · 9b3259fa-21e0-429f-bb2f-df6ebf725bd4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1272743
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 1271.55(d)(2)Information, English or translated-authenticity
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
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Other FDA inspections of Conceive Fertility Center
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2021 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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