FDA 483 - New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C - March 28, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Inspection Date
- March 28, 2025
- Product Type
- Other
ID · 716346de-d3cb-4caa-baf5-184f337d1ab8