# FDA 483 - Kearney, Susan L., M.D., Clinical Investigator - May 10, 2022

Source: https://www.keypedia.com/records/483/kearney-susan-l-md-clinical-investigator/5201dead-18ad-45b1-bb9c-c7787592a66c

> FDA 483 for Kearney, Susan L., M.D., Clinical Investigator on May 10, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kearney, Susan L., M.D., Clinical Investigator
- Inspection Date: 2022-05-10
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: Susan L. Kearney, M.D., Clinical Investigator, was inspected by the FDA from May 2-10, 2022. The inspection revealed a significant issue regarding the oversight of a clinical study, specifically the failure to ensure proper IRB review and reporting of local problems and adverse events. This indicates a serious lapse in regulatory compliance for clinical investigations.

## Related Officers

- [Investigator](https://www.keypedia.com/people/sharon-l-matson/1d2e6d91-1d00-455d-a2e6-a73b1c6b82cc)

Company: https://www.keypedia.com/companies/kearney-susan-l-md-clinical-investigator/918900d1-e959-4171-9ed3-b4b0e5814d1a

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d