# FDA WARNING_LETTER - St Joseph Mercy Oakland IRB - April 22, 2013

Source: https://www.keypedia.com/records/warning_letter/st-joseph-mercy-oakland-irb/86428f8a-5edc-4edf-b644-82d5cfd0a996

> FDA WARNING_LETTER for St Joseph Mercy Oakland IRB on April 22, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: St Joseph Mercy Oakland IRB
- Inspection Date: 2013-04-22
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to St. Joseph Mercy Oakland Health System following an inspection of their Institutional Review Board (IRB) from April 17-22, 2013. The inspection revealed several violations of 21 CFR Part 56 (Institutional Review Boards), Part 50 (Protection of Human Subjects), and Part 812 (Investigational Device Exemptions).

Key violations include:
1.  **Failure to prepare, maintain, and follow written procedures for initial and continuing review of research [21 CFR 56.108(a) and 56.115(a)(6)]**: The IRB failed to document the rationale for Significant Risk/Non-Significant Risk determinations in meeting minutes, lacked procedures for reporting findings to the institution, and failed to review a study's renewal prior to its expiration.
2.  **Failure to review proposed research at convened meetings with a majority of members present [21 CFR 56.108(c)]**: The IRB reviewed and approved studies when less than a majority of members were present.
3.  **Failure to promptly report to the FDA any suspension or termination of approval and failure to prepare written procedures [21 CFR 56.113 and 21 CFR 56.115(a)(6)]**: The IRB failed to report a suspension of approval to the FDA.
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## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Michael K. Smith](https://www.keypedia.com/people/michael-k-smith/20839011-bd5f-42cd-a84d-9ceae0724775)
- [Kristina C. Borror](https://www.keypedia.com/people/kristina-c-borror/c999144c-19df-4ad2-a9b0-9b06f06fee31)

Company: https://www.keypedia.com/companies/st-joseph-mercy-oakland-irb/0163f703-8837-4b70-8fb7-4a60287b59cc

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7