FDA 483 - Chrisette M. Dharmagunaratne, M.D. - February 07, 2025

An FDA inspection of Chrisette M. Dharmagunavatne, M.D., a clinical investigator in Dallas, TX, revealed a significant deviation from the investigational plan. The primary issue involved the incorrect dosing of three subjects due to a calculation error where pounds were used instead of kilograms for weight-based drug administration. This indicates a failure to adhere to the study protocol, potentially impacting subject safety and data integrity.