Andre Kalil, M.D.January 14, 2022

FDA 483 - Andre Kalil, M.D. - January 14, 2022

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Record Details

Andre C. Kalil, M.D., Clinical Investigator, was inspected in Omaha, NE, and cited for multiple deficiencies related to clinical trial conduct. The inspection revealed significant issues with informed consent procedures, including failure to obtain consent, providing consent in the wrong language, and improper documentation. Additionally, the investigator failed to provide adequate oversight of study staff and maintain accurate case histories.

Company: Andre Kalil, M.D.
Inspection Date: January 14, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
Person: Courtney R. Bratina (issuing_officer)

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ID · 7bf08e2b-f585-4584-8ed6-665ac26e0c25