FDA 483 - Andrew A. Nierenberg, M.D. - February 21, 2020

An FDA inspection of Andrew A. Nierenberg, M.D. in Boston, MA, identified significant deficiencies in the conduct of two clinical trials. The inspection revealed failures in monitoring study progress, maintaining adequate case histories, and adhering to the investigational plan and protocol. These issues indicate a lack of proper oversight and documentation in clinical research.