Jane M. Zochling, FRACP, PhD – FDA 483, May 1, 2026

An FDA inspection of Clinical Investigator Jane M. Zochling, FRACP, PhD in Hobart, Tasmania, Australia, revealed a failure to prepare or maintain adequate and accurate case histories. Specifically, the firm did not document subjects' concomitant medication intake within 24 hours prior to disease activity assessments and failed to complete electronic case report forms for various assessments collected on paper source records for multiple subjects. This indicates significant issues with data integrity and record-keeping during clinical investigations.