WORLD SOURCE SIMPLE LLC – FDA 483, Mar 10, 2026

WORLD SOURCE SIMPLE LLC, an initial importer and distributor of Class I and Class II medical devices in Lima, OH, was cited for significant deficiencies in its quality management system. The inspection revealed a complete absence of a documented quality system, including a quality policy, objectives, and procedures for complaint handling and Medical Device Reporting. Additionally, personnel lacked documented training and experience for quality operations.