# FDA 483 - James W. Findling, M.D. - August 02, 2019

Source: https://www.keypedia.com/records/483/james-w-findling-md/df56a1cd-739b-4e47-9683-4f1ec20e7fe7

> FDA 483 for James W. Findling, M.D. on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: James W. Findling, M.D.
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Dr. James Findling, Clinical Investigator, in Milwaukee, WI, from July to August 2019, revealed significant issues with clinical study conduct and IRB reporting. The firm failed to follow the investigational plan regarding subject eligibility, randomization, withdrawal, and dose adjustments. Additionally, the site did not ensure proper IRB oversight by failing to report significant protocol deviations and adverse events in a timely manner.

## Related Documents

- [483 - 2021-08-26](https://www.keypedia.com/records/483/james-w-findling-md/3d72d0b8-066b-4677-bb71-038521dc471b)

## Related Officers

- [Bioresearch Monitoring Specialis](https://www.keypedia.com/people/denise-l-burosh/075a442f-67e0-4a65-9c09-e8819a329773)

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