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

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.