FDA 483 - Morgan Newton Comp. - May 29, 2025

An FDA inspection of Morgan Newton Comp., a contract manufacturer in Plano, TX, revealed two significant issues related to validation. The firm failed to validate a critical process used for inspecting PCB boards and also did not validate its Enterprise Resource Planning (ERP) software, which is essential for managing quality records and Class II device production. These findings indicate a lack of adherence to established validation procedures for manufacturing processes and software.