# FDA 483 - Baptist Health IRB #1 - September 28, 2023

Source: https://www.keypedia.com/records/483/baptist-health-irb-1/d0b3b560-083e-4f5a-822e-e27bc18d212a

> FDA 483 for Baptist Health IRB #1 on September 28, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baptist Health IRB #1
- Inspection Date: 2023-09-28
- Product Type: other
- Office Name: New Orleans District Office
- Summary: Baptist Health IRB #1 in Montgomery, AL, received an FDA Form 483 with two observations concerning communication with investigators. The IRB failed to properly notify investigators regarding both the termination of research approval and the approval of proposed research activities, instead communicating with study coordinators.

## Related Officers

- [investigator](https://www.keypedia.com/people/kellie-r-riggs/556818c6-eb9a-48a5-9630-aba7a807ec07)

Company: https://www.keypedia.com/companies/baptist-health-irb-1/4c5a9c14-34fd-4899-812c-c7278bf89a75

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