FDA 483 - Jan L. Brandes, M.D. - October 18, 2019

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.