Andrew J. Wagner, M.D.March 4, 2021

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

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Record Details

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.

Company: Andrew J. Wagner, M.D.
Inspection Date: March 4, 2021
Product Type: Drugs
Office: Division of Northeast Imports
People: Victoria M. Daddeo (issuing_officer)
Jose A. Torres (investigator)

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ID · 487651d5-e5be-4137-b089-a9d99bc9df94