Ivers-Lee AG – FDA 483, May 9, 2022

IVERS-LEE AG, a device manufacturer, was inspected by the FDA from May 9-12, 2022. The inspection revealed significant deficiencies in batch recordkeeping for autoinjector assembly, inadequate validation and qualification of assembly machines, and insufficient frequency and scope of quality audits. These observations indicate a lack of robust quality system controls for the manufacturing of their autoinjector products.