Rajnish V. Nagarkar, M.D.May 8, 2024

FDA 483 - Rajnish V. Nagarkar, M.D. - May 08, 2024

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Record Details

An FDA inspection of Rajnish V. Nagarkar, MD, a clinical investigator in Nashik, Maharashtra, India, revealed a significant issue regarding the conduct of a clinical trial. The inspection found a failure to adhere to Good Clinical Practices and the investigational plan, specifically concerning the timely collection of assessments. This indicates a serious deviation from established study protocols.

Company: Rajnish V. Nagarkar, M.D.
Inspection Date: May 8, 2024
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Tawny L. Colling (investigator)

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ID · f10fff9f-061f-4880-8cbd-a4f86c035b58