# FDA 483 - Sher Fertility Solutions New York - July 22, 2025

Source: https://www.keypedia.com/records/483/sher-fertility-solutions-new-york/f0fcb75e-2eb8-40d3-b7d3-2f06cf96b53f

> FDA 483 for Sher Fertility Solutions New York on July 22, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sher Fertility Solutions New York
- Inspection Date: 2025-07-22
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Sher Fertility Solutions New York was inspected and cited for significant deficiencies in donor screening, HCT/P labeling, and record-keeping practices. Observations included failures to screen donors for communicable disease risk factors, improper labeling of reproductive tissues, and inaccurate or incomplete donor eligibility records. These issues indicate a moderate level of severity regarding compliance with human tissue regulations.

## Related Documents

- [483 - 2019-06-10](https://www.keypedia.com/records/483/sher-fertility-solutions-new-york/60a4eea9-ba7e-4044-bc90-8acf3f08a77c)
- [483 - 2022-04-01](https://www.keypedia.com/records/483/sher-fertility-solutions-new-york/4fc26623-af9a-4c60-bf74-0407d80493c6)

## Related Officers

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

Company: https://www.keypedia.com/companies/sher-fertility-solutions-new-york/8fbb781a-25d6-453b-ad55-4393ca334317

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