FDA 483 - Rejuvenating Fertility Center - December 23, 2025
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An FDA inspection of Rejuvenating Fertility Center in New York, NY, revealed significant deficiencies in their procedures for screening, testing, and determining the eligibility of HCT/P (oocyte) donors. The firm lacked adequate standard operating procedures for donor eligibility, failed to screen donors for critical risk factors like CJD and prior positive HIV/Hepatitis tests, and did not properly label HCT/Ps with appropriate warning statements regarding infectious disease risks. These issues indicate a failure to ensure the safety and proper handling of human reproductive tissues.
ID · 09afc17a-8bba-48e3-ab82-787d2686b863