FDA Inspection
Fertility and IVF Center of Miami IncFertility and IVF Center of Miami Inc – FDA Inspection, Sep 27, 2016
Record Details
This FDA Inspection record concerns Fertility and IVF Center of Miami Inc, with an inspection on September 27, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 27, 2016
- Product Type
- Biologics
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ID · 99f1dac9-4217-46b4-9fcd-6f463b566fc7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987767
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.55(d)(2)Information, English or translated-authenticity
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fertility and IVF Center of Miami Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2026 | Not classified | Florida District Office | |
| April 21, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 25, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 23, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 30, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Fertility and IVF Center of Miami Inc
- FDA Inspection 1310146 - 2026-03-19
- FDA Inspection 1203660 - 2023-04-21
- FDA Inspection 1100799 - 2019-06-25
- FDA Inspection 888839 - 2014-07-23
- FDA Inspection 717412 - 2011-03-30
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