FDA Inspection
Generation Next FertilityGeneration Next Fertility – FDA Inspection, Jan 12, 2024
Record Details
This FDA Inspection record concerns Generation Next Fertility, with an inspection on January 12, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · bb8adc94-e7a3-4850-97f0-b45c75af0ce2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1226902
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Generation Next Fertility
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2022 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 26, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Generation Next Fertility
- FDA Inspection 1170393 - 2022-05-25
- FDA Inspection 1060015 - 2018-07-26
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