# FDA 483 - Louisiana State University Health Sciences Center IRB - July 26, 2023

Source: https://www.keypedia.com/records/483/louisiana-state-university-health-sciences-center-irb/3c07502f-73b0-4f4a-a698-0694d3c9cbed

> FDA 483 for Louisiana State University Health Sciences Center IRB on July 26, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Louisiana State University Health Sciences Center IRB
- Inspection Date: 2023-07-26
- Product Type: other
- Office Name: New Orleans District Office
- Summary: The FDA inspected Louisiana State University Health Sciences Center, an Institutional Review Board (IRB), and identified significant deficiencies in its operations. Observations included failures to follow written procedures for initial and continuing review, leading to lapsed study approvals and enrollment of subjects during these lapses. The IRB also failed to promptly report instances of noncompliance and study terminations to the FDA, and its meeting minutes lacked sufficient detail regarding administrative closures.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/koffi-a-amegadje/817a228e-0003-43d0-bf59-71aeba0fd1f5)

Company: https://www.keypedia.com/companies/louisiana-state-university-health-sciences-center-irb/7d785a38-4c35-4b34-b27e-21d8808272c5

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea