Cordica Medical (formerly Team Technologies Molding) – FDA 483, Jun 8, 2026

Cordica Medical, a contract manufacturer of Class II medical devices in Batavia, IL, received a Form 483 citing three observations related to its quality management system. The inspection revealed deficiencies in maintaining appropriate personnel training records, inadequate planning and development of product realization processes, and incomplete or unreferenced quality system documentation. These issues indicate a lack of robust control over critical manufacturing and quality assurance activities.