FDA Inspection
Boca FertilityBoca Fertility – FDA Inspection, Aug 6, 2018
Record Details
This FDA Inspection record concerns Boca Fertility, with an inspection on August 6, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Person
- Colleen M. Aspinwall (Issuing Officer)
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ID · 8571ebc1-7eda-4241-ac49-ad09397834d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061244
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 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)Procedures for all other requirements
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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 |
| December 5, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 1112144 - 2019-12-05
- FDA Inspection 985391 - 2016-05-03
- FDA Inspection 823857 - 2013-03-21
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