# FDA 483 - Kofinas Fertility Group - April 09, 2025

Source: https://www.keypedia.com/records/483/kofinas-fertility-group/2cb620d5-1652-4c15-b89e-0813a4bb851b

> FDA 483 for Kofinas Fertility Group on April 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kofinas Fertility Group
- Inspection Date: 2025-04-09
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Kofinas Fertility Group in New York revealed significant deficiencies in their handling of reproductive human tissues. The firm failed to properly determine donor eligibility based on complete screening and testing, leading to potential communicable disease risks. Additionally, issues were identified with inadequate labeling of HCT/Ps and inaccurate or incomplete donor eligibility records.

## Related Documents

- [483 - 2023-07-25](https://www.keypedia.com/records/483/kofinas-fertility-group/f93f6c79-4dfe-433d-a3d7-50fe72da9871)

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/kofinas-fertility-group/09d3a33d-78bd-4b53-9d89-474a34b3aecf

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961