FDA 483 - Rockford Specialties - September 10, 2019

An FDA inspection of Rockford Specialties, a contract manufacturer in Loves Park, IL, revealed significant deficiencies in its quality management system. The firm failed to appoint a management representative for quality and did not ensure its quality policy was understood or implemented by employees, with one issue being a repeat observation from a previous inspection. These findings indicate a concerning lack of adherence to fundamental quality system requirements.