FDA 483 - Donald M Brandon MD - February 24, 2023

An FDA inspection of Donald M Brandon MD in San Diego, CA, revealed a significant issue regarding the maintenance of accurate case histories and informed consent. The firm failed to maintain essential medical history, source records, and signed informed consent for a subject enrolled and dosed in the Sanofi Pasteur Inc. MET50 study. This indicates a serious lapse in record-keeping and patient protection protocols.