FDA Inspection
Boca FertilityBoca Fertility – FDA Inspection, Dec 5, 2019
Record Details
This FDA Inspection record concerns Boca Fertility, with an inspection on December 5, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Boca Fertility
- Inspection Date
- December 5, 2019
- Product Type
- Biologics
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ID · e7a6079e-9545-4509-b580-4eba5fbe4a98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1112144
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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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 |
| 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 1221664 - 2023-11-01
- FDA Inspection 1061244 - 2018-08-06
- FDA Inspection 985391 - 2016-05-03
- FDA Inspection 823857 - 2013-03-21
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