FDA 483 - Smitha Reddy, M.D. - August 20, 2021

An FDA inspection of Smitha Reddy, M.D. in Poway, CA, revealed significant deficiencies in the conduct of clinical investigations across multiple protocols. The firm failed to adhere to investigational plans, maintain adequate and accurate case histories, and ensure proper informed consent. These issues indicate a lack of control over study procedures, subject eligibility, investigational product management, and adverse event reporting, compromising the integrity of the clinical trial data.