# FDA 483 - University of Miami Infertility Center - September 09, 2022

Source: https://www.keypedia.com/records/483/university-of-miami-infertility-center/52677459-dc6c-4c22-89d3-6bd3a161c82c

> FDA 483 for University of Miami Infertility Center on September 09, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Miami Infertility Center
- Inspection Date: 2022-09-09
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA inspected the University of Miami Infertility Center and identified significant deficiencies related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The facility failed to ensure donors were free of communicable disease agents, determined donor eligibility prematurely, and did not properly label HCT/Ps from ineligible donors with biohazard warnings. Two of these critical observations were repeat findings from a prior inspection, indicating persistent non-compliance.

## 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)
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## Related Officers

- [Ivan E. Reyes](https://www.keypedia.com/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)

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