FDA 483 - LEO Pharma Ireland - June 24, 2022

An FDA inspection of LEO Pharma Ireland in Dublin identified two significant observations. The firm failed to maintain adequate air pressure and dust control equipment, and its electronic records were found to be unreliable due to inconsistencies between logbook entries and the Business Management System. Additionally, the inspection revealed defects in the plumbing system, including an undetected leak, and a lack of procedures for frequent physical inspections, which could lead to drug product contamination.