FDA 483 - Blair M. Brengle, M.D. - July 08, 2021

Blair M. Brengle, M.D., a clinical investigator in Indianapolis, IN, was cited for significant deficiencies in clinical trial conduct. The inspection revealed failures in maintaining accurate case histories, including issues with subject eligibility, documentation, and data integrity. Additionally, the firm failed to report Serious Adverse Events in a timely manner and conducted study procedures on subjects before obtaining proper informed consent.