Rockford Specialties – FDA 483, Apr 29, 2026

Rockford Acquisition Company, LLC in Loves Park, IL, a contract manufacturer of Class II medical devices, was cited for significant deficiencies in its quality management system. The inspection revealed a lack of documented and maintained procedures for critical processes such as risk management, process validation, equipment qualification, complaint handling, preventive actions, and data analysis. These findings indicate a fundamental breakdown in the firm's ability to ensure product quality and regulatory compliance.