FDA 483 - New York Cryo - April 25, 2022

New York Cryo, a reproductive human tissue establishment in Great Neck, NY, was cited for significant deficiencies in its HCT/P donor eligibility determination processes. Observations included approving donors with communicable disease risk factors, failing to complete required testing or review test results before eligibility, and lacking adequate standard operating procedures for donor screening. Additionally, the firm's HCT/P records did not properly document the establishment responsible for donor eligibility determinations.