Coeur Inc. – FDA 483, Feb 11, 2026

Coeur Inc., a contract manufacturer in Washington, NC, was cited with two observations during an FDA inspection. The firm failed to adequately incorporate customer complaint feedback regarding syringe breakage into its risk management processes, leaving patient and user risks unassessed. Additionally, the company did not conduct required on-site audits of a critical sterilization supplier for its Class II medical devices, indicating deficiencies in quality system controls related to product safety and supplier oversight.