# FDA 483 - Mother Frances Hospital IRB - March 04, 2011

Source: https://www.keypedia.com/records/483/mother-frances-hospital-irb/53192a8e-23d1-4fa4-bddc-f07d2eab7677

> FDA 483 for Mother Frances Hospital IRB on March 04, 2011. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mother Frances Hospital IRB
- Inspection Date: 2011-03-04
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of Mother Frances Hospital IRB in Tyler, TX, revealed significant deficiencies in its operations. The IRB failed to conduct timely continuing reviews of research studies and maintain sufficiently detailed meeting minutes. Furthermore, the IRB lacked adequate written procedures for determining review frequency, verifying material changes, and promptly reporting serious noncompliance, unanticipated problems, or suspensions to the FDA.

## Related Documents

- [483 - 2013-04-02](https://www.keypedia.com/records/483/mother-frances-hospital-irb/69469d52-c983-49b6-ab65-9b89cc5ff4a1)

## Related Officers

- [investigator](https://www.keypedia.com/people/leighton-k-ngai/39fc01c8-e40a-45d4-910a-068955d16a06)

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

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