FDA 483 - Puma Biotechnology, Inc. - May 24, 2019

Puma Biotechnology, Inc. in Los Angeles, CA, was cited for failing to ensure proper monitoring of a clinical study. The inspection revealed significant issues with incorrect subject stratification and the Medical Monitor's oversight, leading to non-compliance with the study protocol. Furthermore, the firm did not include acknowledged stratification errors and a formal impact analysis in its clinical study report submitted to the FDA.