FDA 483 - New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C - March 28, 2025

An FDA inspection of New York Reproductive Wellness Medicine, P.C. in Syosset, NY, revealed a significant violation regarding the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to prominently label HCT/Ps with appropriate warning statements when donor eligibility requirements were not met, including instances involving a donor with Creutzfeldt Jacob Disease (CJD) risk and reproductive tissues shipped without proper communicable disease risk warnings. This lapse indicates a serious concern for recipient safety and regulatory compliance.