Sher Fertility Solutions New YorkJuly 22, 2025

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

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Record Details

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.

Company: Sher Fertility Solutions New York
Inspection Date: July 22, 2025
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East I
Person: Irina Gaberman (Investigator)

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ID · f0fcb75e-2eb8-40d3-b7d3-2f06cf96b53f