# FDA 483 - University of Miami Infertility Center - June 13, 2019

Source: https://www.globalkeysolutions.net/records/483/university-of-miami-infertility-center/6fc7b1d9-69c4-461a-b82e-6ec6b9b656ec

> FDA 483 for University of Miami Infertility Center on June 13, 2019. 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: 2019-06-13
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The University of Miami Reproductive and Fertility Center received an FDA Form 483 for failing to establish and maintain procedures for donor eligibility screening of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This included specific deficiencies in screening for ZIKV, West Nile Virus NAT, and HBV NAT. This is a repeat deficiency, indicating a persistent issue.

## Related Documents

- [483 - 2018-07-12](https://www.globalkeysolutions.net/records/483/university-of-miami-infertility-center/c2ee1861-6b90-4f90-b5f3-5130cf301f2b)
- [483 - 2022-09-09](https://www.globalkeysolutions.net/records/483/university-of-miami-infertility-center/52677459-dc6c-4c22-89d3-6bd3a161c82c)
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## Related Officers

- [Annette Melendez](https://www.globalkeysolutions.net/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)

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

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