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

Source: https://www.keypedia.com/records/warning_letter/memorial-hospital-of-south-bend-irb/dff62070-1ea8-4bba-b711-3cdb84be85d5

> FDA WARNING_LETTER for Memorial Hospital Of South Bend, IRB on April 23, 2012. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Memorial Hospital Of South Bend, IRB
- Inspection Date: 2012-04-23
- Office Name: Department of Health and Human Services
- Summary: The FDA issued a Warning Letter to Memorial Hospital of South Bend's IRB following an inspection from April 11-23, 2012, which found non-compliance with 21 CFR Parts 50 and 56 concerning human subject protection in FDA-regulated clinical investigations.

Key violations include:
1.  **Failure to determine and document compliance with 21 CFR Part 50, Subpart D (Additional Safeguards for Children in Clinical Investigations)** for pediatric studies, specifically three listed studies. The IRB's proposed corrective actions were deemed inadequate for lacking specific determinations, copies of revised procedures, and timelines.
2.  **Failure to prepare, maintain, and follow required written procedures** for reporting unanticipated problems, serious or continuing noncompliance, and suspension/termination of IRB approval. The response was inadequate due to missing revised procedures.
3.  **Failure to prepare and maintain adequate documentation of IRB activities**, including meeting minutes, leading to discrepancies in informed consent document approvals and unclear initial vs. continuing review status for a protocol. The response was inadequate due to missing revised procedures.
4.  **Failure to review proposed research at convened meetings with a majority of members present, including at least one nonscientific member.** A February 4, 2009, meeting lacked a nonscientific member. The response was inadequate due to missing revised procedures.
5.  **Failure to ensure no member participated in review with a

## Related Documents

- [483 - 2012-04-23](https://www.keypedia.com/records/483/memorial-hospital-of-south-bend-irb/29c47c1f-8c7b-4adb-b65a-78c24cc861d8)

## Related Officers

- [Thomas N. Moreno](https://www.keypedia.com/people/thomas-n-moreno/c6b7a1f1-4b91-4d2c-898e-d0578c3eab7a)

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

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861