FDA 483 - Chelsea Fertility NYC - November 22, 2024

Chelsea Fertility NYC, a reproductive human tissue establishment in New York, was inspected by the FDA from November 18-22, 2024. The inspection revealed significant deficiencies in donor eligibility determinations, including untimely infectious disease testing, inadequate screening for communicable diseases, and improper handling of HCT/Ps prior to complete eligibility. Additionally, donor eligibility records were found to be inaccurate, illegible, or incomplete.