FDA 483 - Thatthan Suksombooncharoen, MD - August 26, 2022

The FDA inspected Thatthan Suksombooncharoen, MD, a clinical investigator in Chiang Mai, Thailand, from August 22-26, 2022. The inspection revealed a failure to prepare or maintain accurate case histories for study protocol D933AC00001 (TOPAZ-1). Specifically, the firm failed to report numerous concomitant medications and adverse events to the sponsor, and one adverse event was incorrectly reported, indicating significant data integrity issues in clinical trial conduct.