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483
•Diwakar Davar, M.D.•October 19, 2023

Diwakar Davar, M.D. – FDA 483, Oct 19, 2023

Record Details

Diwakar Davar, M.D., a Sponsor-Investigator in Pittsburgh, PA, was cited for significant deficiencies related to Institutional Review Board (IRB) oversight during clinical studies. The inspection revealed that research activities continued during a lapse in IRB approval and that changes to a study protocol were implemented without prior IRB approval. These findings indicate a failure to ensure proper ethical and regulatory review of clinical research.

Company
Diwakar Davar, M.D.
Inspection date
October 19, 2023
Product type
drugs
Office
Philadelphia District Office
Person
  • Cynthia L. Rakestraw
View Company Profile

ID · a4b080ec-fb6d-49c5-8b55-676890677bd0

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