FDA Inspection
Genesis Fertility & Reproductive MedicineGenesis Fertility & Reproductive Medicine – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Genesis Fertility & Reproductive Medicine, with an inspection on December 21, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 21, 2018
- Product Type
- Biologics
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ID · e87feee9-b0a1-4f16-a8a8-669c581483c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075190
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Genesis Fertility & Reproductive Medicine
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2026 | Not classified | New York District Office | |
| August 4, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 23, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 18, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 20, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Genesis Fertility & Reproductive Medicine
- FDA Inspection 1301302 - 2026-01-27
- FDA Inspection 1214469 - 2023-08-04
- FDA Inspection 1112313 - 2019-10-23
- FDA Inspection 992579 - 2016-11-18
- FDA Inspection 903598 - 2014-11-20
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