# FDA 483 - Mother Frances Hospital IRB - April 02, 2013

Source: https://www.globalkeysolutions.net/records/483/mother-frances-hospital-irb/69469d52-c983-49b6-ab65-9b89cc5ff4a1

> FDA 483 for Mother Frances Hospital IRB on April 02, 2013. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mother Frances Hospital IRB
- Inspection Date: 2013-04-02
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of Mother Frances Hospital IRB in Tyler, TX, revealed significant deviations from its written procedures for human research protection. The firm failed to properly conduct continuing reviews, including issues with unqualified staff reviewing clinical events and incomplete documentation. Additionally, the IRB did not consistently follow its procedures for reporting actions to investigators and maintaining complete correspondence records.

## Related Documents

- [483 - 2011-03-04](https://www.globalkeysolutions.net/records/483/mother-frances-hospital-irb/53192a8e-23d1-4fa4-bddc-f07d2eab7677)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/elisa-m-fleming/bfb8308a-9b37-4051-90f2-66066c26e1f4)

Company: https://www.globalkeysolutions.net/companies/mother-frances-hospital-irb/5068618d-52b8-40ac-b357-61524c081190

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9