FDA 483 - Santosh M. Nair, MD - February 26, 2020

An FDA inspection of Santosh M. Nair, MD, Clinical Investigator, revealed significant deviations in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan and statement of investigator, maintain adequate drug disposition records, and ensure complete and accurate case histories for study subjects. These findings indicate a lack of control over critical aspects of clinical trial conduct.