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

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.