# FDA 483 - Memorial Hospital Of South Bend, IRB - April 23, 2012

Source: https://www.keypedia.com/records/483/memorial-hospital-of-south-bend-irb/29c47c1f-8c7b-4adb-b65a-78c24cc861d8

> FDA 483 for Memorial Hospital Of South Bend, IRB on April 23, 2012. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Memorial Hospital Of South Bend, IRB
- Inspection Date: 2012-04-23
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Memorial Hospital Of South Bend's Institutional Review Board (IRB) revealed multiple deficiencies, primarily concerning the oversight of pediatric research. The IRB failed to ensure compliance with specific regulations for studies involving children, maintain proper documentation for expedited reviews and serious adverse events, and adhere to quorum requirements. Furthermore, the IRB lacked adequate procedures for member identification, conflict of interest management, non-scientific representation, and reporting of noncompliance or unanticipated problems.

## Related Documents

- [WARNING_LETTER - 2012-04-23](https://www.keypedia.com/records/warning_letter/memorial-hospital-of-south-bend-irb/dff62070-1ea8-4bba-b711-3cdb84be85d5)

## Related Officers

- [U.S. Food and Drug Administration](https://www.keypedia.com/people/myra-k-casey/a2fae714-2ba3-4c60-9f54-990fc7b169c9)

Company: https://www.keypedia.com/companies/memorial-hospital-of-south-bend-irb/076f05fd-c4ad-4788-8882-70a74181bfb9

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0