# FDA 483 - New York Cryo - March 21, 2024

Source: https://www.keypedia.com/records/483/new-york-cryo/d7f52016-4169-4562-9b05-b25b6f623f36

> FDA 483 for New York Cryo on March 21, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: New York Cryo
- Inspection Date: 2024-03-21
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of New York Cryo, a reproductive human tissue facility in Great Neck, NY, revealed a critical lapse in donor eligibility determination. The firm failed to properly screen a directed semen donor who tested positive for a high-risk factor, subsequently distributing cryopreserved semen from this ineligible donor. This indicates a serious deviation from established donor screening and eligibility procedures.

## Related Documents

- [483 - 2019-01-23](https://www.keypedia.com/records/483/new-york-cryo/236b776f-4af6-47a1-84a4-06a05cb781b9)
- [483 - 2022-04-25](https://www.keypedia.com/records/483/new-york-cryo/db7c52b2-e75a-435f-a65a-e8b2d1596f4b)
- [EIR - 2022-04-25](https://www.keypedia.com/records/eir/new-york-cryo/0cd735e8-adb7-4972-8828-c10cdc6a8678)

## Related Officers

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

Company: https://www.keypedia.com/companies/new-york-cryo/7fb7224b-266e-4404-8c5b-8999319c5a95

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