FDA 483 - Nicola Longo, M.D., Ph.D. - March 10, 2023

Nicola Longo, M.D., Ph.D., a clinical investigator in Salt Lake City, UT, was cited for significant deficiencies during an FDA inspection. Observations included multiple failures to adhere to study protocol requirements, such as incomplete screening assessments, improper management of concomitant medications, unauthorized changes to infusion rates, and administration of expired investigational product. Additionally, the firm failed to obtain informed consent from a human subject prior to conducting study activities and did not maintain adequate and accurate case histories.