# FDA 483 - Priya U. Kumthekar, M.D. - April 28, 2023

Source: https://www.keypedia.com/records/483/priya-u-kumthekar-md/21461dbb-b485-4067-ba3f-39e1e060d8db

> FDA 483 for Priya U. Kumthekar, M.D. on April 28, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Priya U. Kumthekar, M.D.
- Inspection Date: 2023-04-28
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Priya U. Kumthekar, M.D., a clinical investigator in Chicago, IL, revealed a significant deficiency in the conduct of an investigation. The firm failed to perform all protocol-required lab assessments for all fifteen enrolled subjects, indicating a deviation from the signed statement of investigator and investigational plan. This suggests a serious lapse in adherence to clinical trial protocols.

## Related Officers

- [investigator](https://www.keypedia.com/people/jeanne-j-thai/f7b057a4-ab4c-43de-a448-384ff9f8598f)

Company: https://www.keypedia.com/companies/priya-u-kumthekar-md/06eb297f-2148-4b0c-82e6-9082307ca20b

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669