# FDA 483 - James W. Findling, M.D. - August 26, 2021

Source: https://www.keypedia.com/records/483/james-w-findling-md/3d72d0b8-066b-4677-bb71-038521dc471b

> FDA 483 for James W. Findling, M.D. on August 26, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James W. Findling, M.D.
- Inspection Date: 2021-08-26
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of James W. Findling, M.D. in Milwaukee, WI, a clinical investigator, revealed a significant failure in ensuring proper Institutional Review Board (IRB) oversight. The study site failed to submit a revised protocol, which included additional subject safety assessments, for IRB review and approval, resulting in subjects continuing the study under an outdated protocol. This indicates a serious lapse in regulatory compliance regarding clinical study management and subject protection.

## Related Documents

- [483 - 2019-08-02](https://www.keypedia.com/records/483/james-w-findling-md/df56a1cd-739b-4e47-9683-4f1ec20e7fe7)

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Company: https://www.keypedia.com/companies/james-w-findling-md/3e9bd1d5-745f-4bce-b7b4-5799e3cbf441

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