FDA 483 - GLOBAL FERTILITY & GENETICS - December 09, 2024

GLOBAL FERTILITY & GENETICS in New York, NY, was cited on a Form 483 for deficiencies in its reproductive human tissue operations. The inspection revealed that HCT/P donors were not consistently determined eligible based on screening and testing results, leading to the use or distribution of tissues from ineligible donors. Furthermore, the firm failed to properly label HCT/Ps from ineligible donors with biohazard warnings and lacked adequate procedures for donor screening and eligibility determination.