FDA Inspection
Boca FertilityBoca Fertility – FDA Inspection, May 3, 2016
Record Details
This FDA Inspection record concerns Boca Fertility, with an inspection on May 3, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Boca Fertility
- Inspection Date
- May 3, 2016
- Product Type
- Biologics
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ID · 24cb1b46-0176-41ab-9599-a311c8dd8d40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985391
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Procedures for all other requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boca Fertility
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2023 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 |
| March 21, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Boca Fertility
- FDA Inspection 1221664 - 2023-11-01
- FDA Inspection 1112144 - 2019-12-05
- FDA Inspection 1061244 - 2018-08-06
- FDA Inspection 823857 - 2013-03-21
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