Andre Kalil, M.D. – FDA EIR, Jan 14, 2022

An FDA comprehensive inspection of Andre C. Kalil, M.D., in Omaha, NE, was conducted from January 10 to January 14, 2022. This high-priority inspection, requested by the Office of Scientific Investigations/CDER for a New Drug Application, aimed to review a clinical trial. The inspection revealed significant findings, leading to the issuance of an FDA Form 483, Inspectional Observations, to Dr. Kalil. Key violations included a failure to obtain proper informed consent from subjects before drug administration and study tests, violating informed consent requirements (21 CFR Part 50). Specifically, some subjects were enrolled without any written consent, while others were not provided consent documents in their native language despite verbal translations. Furthermore, consent forms were often not signed or dated legibly at the time of enrollment. The inspection also found that the investigation was not conducted in accordance with the signed statement of the investigator and investigational plan (21 CFR 312.60), involving a lack of adequate oversight as unqualified staff made unauthorized changes to physical exam records. Additionally, there was a failure to maintain adequate and accurate case histories, with numerous source records and error corrections lacking proper signatures and dates. Dr. Kalil acknowledged the findings and committed to providing a written response within fifteen business days, after receiving a verbal warning regarding potential regulatory actions.