FDA Inspection
Fertility Center and Applied Genetics of FloridaFertility Center and Applied Genetics of Florida – FDA Inspection, Mar 3, 2014
Record Details
This FDA Inspection record concerns Fertility Center and Applied Genetics of Florida, with an inspection on March 3, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 3, 2014
- Product Type
- Biologics
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ID · 91f0dd48-b7f2-44b2-bdea-f6e6224c4faf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868342
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.80(b)Specimen collections not timely
- 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 1271.150(c)(1)(iii)Ensurane of compliance
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Other FDA inspections of Fertility Center and Applied Genetics of Florida
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 17, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 12, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 26, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 13, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Fertility Center and Applied Genetics of Florida
- FDA Inspection 1239155 - 2024-05-13
- FDA Inspection 1171193 - 2022-05-17
- FDA Inspection 1052456 - 2018-04-12
- FDA Inspection 985556 - 2016-05-26
- FDA Inspection 583173 - 2009-05-13
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