# FDA 483 - Covenant Medical Center Inc. - April 20, 2011

Source: https://www.keypedia.com/records/483/covenant-medical-center-inc/854210f1-bc02-46a7-9991-c004c0f2843a

> FDA 483 for Covenant Medical Center Inc. on April 20, 2011. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covenant Medical Center Inc.
- Inspection Date: 2011-04-20
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Covenant Healthcare's Institutional Review Board (IRB) in Saginaw, MI, revealed significant deficiencies in its oversight of clinical research. The IRB improperly used expedited review for high-risk studies involving vulnerable populations, failed to manage conflicts of interest among its members, and maintained inadequate documentation for meeting minutes and informed consent processes. These issues indicate a systemic failure to protect human subjects and adhere to regulatory requirements for clinical investigations.

## Related Officers

- [L'Oreal F. Walker](https://www.keypedia.com/people/loreal-f-walker/54e821e1-4646-499e-91f1-a6b37214cb7c)

Company: https://www.keypedia.com/companies/covenant-medical-center-inc/27306bcd-051d-493d-b690-2d4c9b3e3d4a

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