FDA Inspection
Kofinas Fertility GroupFDA Inspection 1210757 - Kofinas Fertility Group - July 25, 2023
Record Details
This FDA Inspection record concerns Kofinas Fertility Group, with an inspection on July 25, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a7f875d9-397c-4a5e-8f0d-cafa3a34bafb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210757
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
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Other FDA inspections of Kofinas Fertility Group
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2025 | VAI | New York District Office | Human Cellular, Tissue, and Gene Therapies |
| February 13, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 25, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 11, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 4, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Kofinas Fertility Group
- FDA Inspection 1266536 - 2025-04-09
- FDA Inspection 1122513 - 2020-02-13
- FDA Inspection 1056801 - 2018-06-25
- FDA Inspection 963390 - 2016-03-11
- FDA Inspection 857553 - 2013-12-04
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