FDA Inspection
Florida Fertility Institute, P.A.Florida Fertility Institute, P.A. – FDA Inspection, Sep 6, 2013
Record Details
This FDA Inspection record concerns Florida Fertility Institute, P.A., with an inspection on September 6, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 6, 2013
- Product Type
- Biologics
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ID · 70587205-8515-4f89-a4af-75fa169161be
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 847578
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.85(c)Reproductive cells or tissues
- 21 CFR 1271.85(c)Reproductive cells or tissues-cell-associated CD
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.75(e)Abbreviated procedure
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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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 |
| February 2, 2023 | VAI | 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 |
Other documents for Florida Fertility Institute, P.A.
- FDA Inspection 1230983 - 2024-01-24
- FDA Inspection 1196726 - 2023-02-02
- FDA Inspection 1122668 - 2020-03-10
- FDA Inspection 1067758 - 2018-06-13
- FDA Inspection 964118 - 2016-01-28
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