FDA 483 - Dwayne Logan, M.D. - August 01, 2023

An FDA inspection of Dwayne K. Logan, M.D., a clinical investigator in Huntington Beach, CA, revealed significant deficiencies in record-keeping and adherence to investigational plans. The inspection found that original source records were missing for multiple subjects and visits, and serious adverse events were not reported to the sponsor or recorded in EDC in a timely manner. Additionally, investigations were not conducted in accordance with the signed statement of investigator and investigational plan.