FDA 483 - David Berz, M.D., Ph.D - January 14, 2025
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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.
ID · bdcd75fa-f5ed-41f7-a39d-e6f8030f8300