FDA Inspection
Southwest Florida Fertility Center, P.A.Southwest Florida Fertility Center, P.A. – FDA Inspection, Mar 8, 2023
Record Details
This FDA Inspection record concerns Southwest Florida Fertility Center, P.A., with an inspection on March 8, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · de1785b9-1d75-4f8f-81ba-c97622d8e42d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199757
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
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Other FDA inspections of Southwest Florida Fertility Center, P.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 14, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 23, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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