FDA 483 - David Berz, M.D., Ph.D - January 14, 2025

An FDA inspection of David Berz, M.D., Ph.D, a clinical investigator in Los Angeles, CA, from January 6-14, 2025, identified two significant observations. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, including enrolling a subject who did not meet inclusion criteria. Additionally, the firm did not prepare or maintain adequate and accurate case histories, with discrepancies noted between source documents.