FDA 483 - Joseph L. Lillo, D.O. - December 09, 2019

An FDA inspection of Joseph L. Lillo, D.O. in Phoenix, AZ, a clinical investigator, revealed a significant issue regarding the maintenance of accurate case histories and informed consent. Specifically, an informed consent form was not properly signed by the Clinical Investigator, and eDiary symptom documentation for a subject was inconsistent. These findings indicate deficiencies in record-keeping and adherence to study protocols.