FDA 483 - Naomi Akita, MD - October 11, 2018

An FDA inspection of Naomi C. Akita, MD, Clinical Investigator, in Suwanee, GA, revealed significant non-compliance across two clinical studies. The firm failed to adhere to the investigational plan by enrolling a subject who met exclusion criteria and did not obtain informed consent from subjects prior to conducting study-related procedures. Additionally, the inspection found inadequate and inaccurate case histories, including inconsistencies in lab sample records, unrecorded treatments, and missing source documents.