FDA 483 - New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C - April 07, 2023

An FDA inspection of New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C in Syosset, NY, identified two significant observations. The firm failed to ensure HCT/P donor eligibility was determined based on complete screening and testing results, specifically for an anonymous oocyte donor. Additionally, accompanying records for anonymous HCT/P donors contained personal identifying information, which is a concern for donor anonymity.