# FDA 483 - Sher Fertility Solutions New York - April 01, 2022

Source: https://www.keypedia.com/records/483/sher-fertility-solutions-new-york/4fc26623-af9a-4c60-bf74-0407d80493c6

> FDA 483 for Sher Fertility Solutions New York on April 01, 2022. 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: 2022-04-01
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Sher Fertility Solutions New York identified two significant observations related to reproductive human tissue. The firm failed to collect donor specimens for communicable disease testing, specifically West Nile Virus, at appropriate times for anonymous oocyte donors. Additionally, the firm did not establish and maintain adequate procedures for testing HCT/P donors, with their SOP lacking sufficient detail for donor eligibility, West Nile Virus testing, and ZIKV risk identification.

## Related Documents

- [483 - 2019-06-10](https://www.keypedia.com/records/483/sher-fertility-solutions-new-york/60a4eea9-ba7e-4044-bc90-8acf3f08a77c)

## 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