FDA 483 - ProMED Concepts, LLC - March 03, 2025

PROMED Concepts, LLC, a contract manufacturer in Brighton, TN, was inspected by the FDA from February 24 to March 3, 2025. The inspection revealed significant and repeat deficiencies in the firm's quality system, specifically regarding corrective and preventive action (CAPA) procedures and the handling of customer complaints. These issues indicate a systemic failure to adequately establish and maintain essential quality processes.