483
Jan L. Brandes, M.D.Jan L. Brandes, M.D. – FDA 483, Oct 18, 2019
Record Details
An FDA inspection of Jan L. Brandes, M.D. at Nashville Neuroscience Group identified significant deficiencies in clinical trial conduct. The firm failed to maintain adequate and contemporaneous case histories for enrolled subjects, leading to issues with data integrity and record-keeping. Additionally, the investigation was not conducted in accordance with the investigational plan, revealing problems with supervision, subject eligibility, and adherence to protocol requirements.
View Company Profile
ID · ad592398-9010-4a48-96f2-cdc37c3ac8cc
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.