FDA 483 - University Reproductive Associates, P.C. - May 10, 2022

University Reproductive Associates, P.C. in Hasbrouck Heights, NJ, was cited for multiple deficiencies related to donor screening, testing, and labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Observations included failures to test for all relevant communicable disease agents, properly screen for risk factors, label HCT/Ps from ineligible donors, collect specimens at appropriate times, and determine donor eligibility based on complete test results. These issues indicate significant concerns regarding the safety and quality control of donor tissues.