FDA 483 - Andrew J. Wagner, M.D. - March 04, 2021

An FDA inspection of Andrew Wagner, a clinical investigator in Boston, MA, revealed a significant issue with non-compliance to an Institutional Review Board (IRB) approved protocol. Specifically, the firm failed to adhere to the investigational plan regarding prohibited medications and procedures for a subject, without obtaining prior medical monitor approval. This indicates a serious deviation from established research guidelines.