483
Blair M. Brengle, M.D.FDA 483 - Blair M. Brengle, M.D. - July 08, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 94dde43e-1ad1-48e8-9bf4-1e90f497f761