483
Chrisette M. Dharmagunaratne, M.D.FDA 483 - Chrisette M. Dharmagunaratne, M.D. - February 07, 2025
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Record Details
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.
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ID · 17b15dba-e97e-4c1c-bb0d-e9fa29899767