# FDA 483 - University of Miami Infertility Center - December 21, 2023

Source: https://www.keypedia.com/records/483/university-of-miami-infertility-center/540dc2e5-9704-4edc-b5ed-f04cf2625f4f

> FDA 483 for University of Miami Infertility Center on December 21, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Miami Infertility Center
- Inspection Date: 2023-12-21
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The University of Miami Infertility Center, a reproductive tissue establishment in Miami, FL, received a Form 483 for failing to adequately screen oocyte and sperm donors for communicable diseases. The firm's standard operating procedures for Zika Virus (ZikV) screening were found to be deficient, as they only required screening if south Florida was designated an active ZikV transmission area by the CDC. This indicates a significant lapse in donor safety protocols.

## Related Documents

- [483 - 2018-07-12](https://www.keypedia.com/records/483/university-of-miami-infertility-center/c2ee1861-6b90-4f90-b5f3-5130cf301f2b)
- [483 - 2019-06-13](https://www.keypedia.com/records/483/university-of-miami-infertility-center/6fc7b1d9-69c4-461a-b82e-6ec6b9b656ec)
- [483 - 2022-09-09](https://www.keypedia.com/records/483/university-of-miami-infertility-center/52677459-dc6c-4c22-89d3-6bd3a161c82c)

## Related Officers

- [Sergio E. Delgado](https://www.keypedia.com/people/sergio-e-delgado/5edfee62-05aa-44aa-9161-def8f31d3ea2)

Company: https://www.keypedia.com/companies/university-of-miami-infertility-center/10cd5557-c3f9-4a2c-823d-f28d4aa09820

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6