FDA EIR - Raed Alalawi, M.D. - June 10, 2021

The FDA conducted an inspection of Clinical Investigator Raed Alalawi, M.D., operating at Banner – University Medicine Lung Institute in Phoenix, AZ, from June 7-10, 2021. The inspection, performed under Compliance Program 7348.811 for Clinical Investigators and referencing regulations such as 21 CFR 312.60, aimed to assess compliance with clinical trial protocols.

The main violation identified was Dr. Alalawi's failure to adequately oversee Protocol A011-09. This lapse resulted in an unqualified clinical coordinator performing investigator-specific assessments and evaluations for study subjects, leading to the deletion of critical source data. Additional issues included inadequate maintenance of drug accountability records for Protocol LTI-302, inconsistent signing of revised informed consents by subjects in Protocols A011-09 and 402-C-1504, and a lack of documented attempts to contact a subject lost to follow-up in Protocol LTI-302.

At the conclusion of the inspection, an FDA-483 Inspectional Observation was issued to Dr. Alalawi. Management stated that immediate corrective actions had been implemented, including Dr. Alalawi's removal from research activities, and committed to providing a written response to the FDA within 15 days. The FDA indicated that further legal sanctions, such as warning letters or disqualification, could be pursued if the corrective actions are not deemed sufficient.