FDA 483 - GLOBAL FERTILITY & GENETICS - October 19, 2022

An FDA inspection of GLOBAL FERTILITY & GENETICS in New York, NY, a reproductive human tissue establishment, revealed significant deficiencies in their donor eligibility determination and screening processes. The firm failed to ensure donors were eligible based on complete screening and testing, lacked detailed screening procedures for various infectious diseases, and maintained inaccurate and illegible donor records. Additionally, donor records improperly included identifying information for anonymous donors.