FDA Inspection
Florida Fertility Institute, P.A.Florida Fertility Institute, P.A. – FDA Inspection, Feb 2, 2023
Record Details
This FDA Inspection record concerns Florida Fertility Institute, P.A., with an inspection on February 2, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 940e275c-dc29-40d1-ba8b-041f1f19b80e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196726
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Florida Fertility Institute, P.A.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 10, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 13, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 28, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 19, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Florida Fertility Institute, P.A.
- FDA Inspection 1230983 - 2024-01-24
- FDA Inspection 1122668 - 2020-03-10
- FDA Inspection 1067758 - 2018-06-13
- FDA Inspection 964118 - 2016-01-28
- FDA Inspection 883830 - 2014-06-19
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