Priya U. Kumthekar, M.D.April 28, 2023

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

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Record Details

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.

Company: Priya U. Kumthekar, M.D.
Inspection Date: April 28, 2023
Product Type: Other
Office: Chicago District Office
Person: Jeanne J. Thai (investigator)

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ID · 21461dbb-b485-4067-ba3f-39e1e060d8db