FDA 483 - New York Fertility Medical Practice, PLLC - May 12, 2022

An FDA inspection of New York Fertility Medical Practice, PLLC, a human reproductive tissue establishment in New York, NY, identified a significant issue regarding donor eligibility. The firm failed to determine donors ineligible even after their specimens tested reactive for communicable disease agents. Specifically, an oocyte donor who tested reactive for syphilis was still deemed eligible, and her oocytes were retrieved, fertilized, transferred, and stored.