FDA Inspection
Boca FertilityBoca Fertility – FDA Inspection, Nov 1, 2023
Record Details
This FDA Inspection record concerns Boca Fertility, with an inspection on November 1, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a6062534-50a3-4e01-b9dd-dd2f75307db1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221664
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boca Fertility
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 6, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 3, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 21, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Boca Fertility
- FDA Inspection 1112144 - 2019-12-05
- FDA Inspection 1061244 - 2018-08-06
- FDA Inspection 985391 - 2016-05-03
- FDA Inspection 823857 - 2013-03-21
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