FDA 483 - Kathleen Jones, M.D., Clinical Investigator - January 13, 2023

Kathlene Jones, M.D., Clinical Investigator in West Des Moines, IA, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. The inspection revealed multiple instances of ineligible subjects being enrolled due to manipulated or incorrectly calculated Body Mass Index (BMI) values. Additionally, study records were altered without justification, indicating significant issues with data integrity and adherence to study protocols.