# FDA 483 - Jackson-Madison County General Hospital  IRB - November 26, 2019

Source: https://www.keypedia.com/records/483/jackson-madison-county-general-hospital-irb/b482a1b7-499e-4b1c-b617-75b9d78f9ca1

> FDA 483 for Jackson-Madison County General Hospital  IRB on November 26, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jackson-Madison County General Hospital  IRB
- Inspection Date: 2019-11-26
- Product Type: other
- Office Name: New Orleans District Office
- Summary: The FDA inspected Jackson-Madison County General Hospital IRB and found several significant deficiencies. The IRB failed to ensure compliance with regulations for pediatric research, did not follow procedures for reporting noncompliance, and neglected annual continuing review of studies. Additionally, the IRB did not maintain required research documents and its membership lacked sufficient diversity.

## Related Officers

- [Consumer Safety Officer/Investigator](https://www.keypedia.com/people/donna-d-gallien/3b5d4a2b-4c8b-4618-a986-3a23c12faad4)

Company: https://www.keypedia.com/companies/jackson-madison-county-general-hospital-irb/39aacce1-f1c8-4968-b346-2ddc0fb680b2

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