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

An FDA inspection of David Berz M.D., operating as Valkyrie Clinical Trials in Los Angeles, CA, was conducted from January 6-14, 2025. This comprehensive, for-cause inspection, requested by the Center for Drug Evaluation and Research, aimed to assess compliance with the Bioresearch Monitoring Compliance Program for Clinical and Sponsor Investigators (7348.811), covering two clinical trials. The inspection resulted in a two-point FDA Form 483, Inspectional Observations. The first observation noted that an investigation was not conducted in accordance with the signed investigator statement and investigational plan, specifically citing the enrollment of a subject who did not meet inclusion criteria (21 CFR 312.60). The second observation identified a failure to prepare or maintain adequate and accurate case histories, evidenced by discrepancies between sponsor-provided dose preparation worksheets and site-created planning sheets for investigational product handling (21 CFR 312.62(b)). Further issues discussed included insufficient documentation regarding investigational product, remote consenting of subjects before obtaining IRB approval for such a practice, and numerous Good Documentation Practice (GDP) deficiencies. The report also highlighted that the clinical investigator did not always implement timely corrective actions for monitor-identified deficiencies, and there were issues with document availability and staff readiness during the inspection. Dr. Berz acknowledged these observations and stated his intent to provide a written response.