FDA 483 - Ming-Shen Dai, M.D., Ph.D. - September 27, 2019

An FDA inspection of Ming-Shen Dai, M.D., Ph.D., a clinical investigator in Taipei City, Taiwan, revealed a significant failure to prepare and maintain accurate case histories for the "PUMA-NER-1301" study. Discrepancies were identified in reported hormone receptor status, visceral disease status, and the documentation of adverse events for multiple study subjects. These findings indicate serious issues with data integrity and record-keeping during the clinical investigation.