FDA 483 - Ronald B. Natale, MD - November 13, 2020

Ronald B. Natale, MD, Clinical Investigator in Los Angeles, CA, was inspected from November 5-13, 2020, for bioresearch monitoring. The inspection revealed a significant deficiency in maintaining adequate and accurate case histories. Specifically, the firm failed to transcribe critical data, including adverse events and concomitant medications, from source documents to electronic case report forms for submission to the study sponsor.