# FDA 483 - Nova Southeastern University IRB #1 - August 17, 2023

Source: https://www.keypedia.com/records/483/nova-southeastern-university-irb-1/a8820506-5a45-4631-9770-46c54ebf0468

> FDA 483 for Nova Southeastern University IRB #1 on August 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nova Southeastern University IRB #1
- Inspection Date: 2023-08-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Nova Southeastern University IRB #1 in Davie, FL, revealed three observations concerning its Institutional Review Board (IRB) operations. The firm failed to adhere to its written procedures for initial research review and omitted critical information from informed consent documents, specifically regarding alternate treatment options and the potential for FDA record inspection. These findings highlight deficiencies in the IRB's compliance with established protocols and informed consent requirements.

## Related Officers

- [Angelica M. Chica](https://www.keypedia.com/people/angelica-m-chica/117a5aa3-e5ed-46f2-bf32-885591c34848)
- [investigator](https://www.keypedia.com/people/emily-a-baldwin/92d70174-7029-44f4-af30-e3230d4e9507)

Company: https://www.keypedia.com/companies/nova-southeastern-university-irb-1/8c5a547e-fd64-4271-96e4-cf9538181bec

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