# FDA 483 - Rejuvenating Fertility Center - December 23, 2025

Source: https://www.keypedia.com/records/483/rejuvenating-fertility-center/09afc17a-8bba-48e3-ab82-787d2686b863

> FDA 483 for Rejuvenating Fertility Center on December 23, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rejuvenating Fertility Center
- Inspection Date: 2025-12-23
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/rejuvenating-fertility-center/86f6b798-1afc-4be5-b553-6c4abe1c3fa3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961