FDA 483 - Johnson & Johnson Vision Care Ireland UC - February 15, 2022

An FDA inspection of Johnson & Johnson Vision Care Ireland US in Limerick, Ireland, a combination drug/device manufacturer, identified 12 significant deficiencies. These issues span inadequate manufacturing process controls, critical data integrity failures in laboratory and electronic records, and a lack of robust quality unit oversight. The firm also demonstrated weaknesses in its CAPA processes, supplier management, and employee GMP training, indicating systemic non-compliance with cGMP requirements.