FDA 483 - Mark P. Christiansen, M.D. - June 23, 2025

An FDA inspection of Mark P. Christiansen, M.D., a clinical investigator in Walnut Creek, CA, revealed significant deviations from an investigational plan and applicable FDA regulations. The investigator failed to conduct a study according to the protocol, including manipulating blood glucose levels contrary to the plan and allowing subjects to enter a specific phase due to personal preference without sponsor approval. Additionally, the investigator did not fully document protocol deviations, specifically regarding subjects experiencing blood glucose levels outside the allowed ranges for extended periods.