FDA Inspection
Kofinas Fertility GroupFDA Inspection 1266536 - Kofinas Fertility Group - April 09, 2025
Record Details
This FDA Inspection record concerns Kofinas Fertility Group, with an inspection on April 9, 2025, issued by the New York District Office, covering biologics.
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ID · 8a9b4743-be1b-4642-9c9b-87b34126e8f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1266536
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Kofinas Fertility Group
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| 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 1210757 - 2023-07-25
- 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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