# FDA 483 - North Florida Reproductive Biology Laboratory - June 28, 2019

Source: https://www.globalkeysolutions.net/records/483/north-florida-reproductive-biology-laboratory/ce4d9582-a93f-4f2d-8005-2924494032dc

> FDA 483 for North Florida Reproductive Biology Laboratory on June 28, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North Florida Reproductive Biology Laboratory
- Inspection Date: 2019-06-28
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of North Florida Reproductive Biology Laboratory in Jacksonville, FL, a human reproductive tissue establishment, identified one observation. The firm failed to adequately screen oocyte donors for disease risks related to xenotransplantation. This indicates a lapse in donor eligibility determination processes.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/julie-d-bringger/4f6b1f96-e559-45bd-bb73-5354ce64552d)
- [Investigator](https://www.globalkeysolutions.net/people/valerie-j-grecek-trinh/d8b9c0fc-0935-4e34-88cf-a9fc4f7805a5)

Company: https://www.globalkeysolutions.net/companies/north-florida-reproductive-biology-laboratory/18591436-499e-4d85-bc09-f81ad18a6d62

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