Rajendra R. Makkar, MD – FDA 483, Aug 5, 2019

An FDA inspection of Rajendra R. Makkar, MD in Los Angeles, CA, revealed significant deviations from a clinical investigational plan. The firm failed to adhere to the study protocol, leading to issues with screening procedures, required laboratory assessments, and timely reporting of adverse events. These failures were observed across multiple subjects, indicating a systemic lack of compliance with the agreed-upon clinical protocol.