FDA 483 - Manhattan Fertility Services LLC - November 05, 2024

Manhattan Fertility Services LLC in New York was cited for significant deficiencies related to donor screening, eligibility determination, and labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed inadequate procedures for donor screening, failure to determine donor eligibility based on complete screening and testing, and improper labeling of HCT/Ps from ineligible donors. Additionally, donor eligibility records were found to be inaccurate and incomplete.