FDA 483 - Generation Next Fertility - May 25, 2022

Generation Next Fertility in New York, NY, received a Form 483 for deficiencies in their human cells, tissues, and cellular and tissue-based products (HCT/P) donor screening and testing processes. The firm failed to properly determine donor eligibility based on screening results and lacked adequate procedures for donor testing and screening. These issues indicate a moderate severity regarding donor safety and compliance with HCT/P regulations.