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483
•Jeffrey W. Taub, M.D.•October 12, 2022

Jeffrey W. Taub, M.D. – FDA 483, Oct 12, 2022

Record Details

Jeffrey W. Taub, MD, Clinical Investigator, in Detroit, MI, was cited for significant issues during an FDA inspection. The investigation was not conducted according to the investigational plan, specifically regarding failures in the informed consent process and a participant receiving unauthorized additional study treatment. Additionally, there were failures to ensure IRB compliance, leading to lapses in study approval for multiple protocols.

Company
Jeffrey W. Taub, M.D.
Inspection date
October 12, 2022
Product type
drugs
Office
Division of Pharmaceutical Quality Operations III
People
  • Andrace Deyampert
  • Jennifer A. Kemp (issuing_officer)
View Company Profile

ID · 503004c8-f98b-4eac-bf4e-97cc5e941ed2

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