FDA 483 - Coupler LLC - August 12, 2021

Coupler Enterprises, a contract packager in Warrington, PA, was inspected by the FDA from July 28 to August 12, 2021, revealing significant deficiencies in their manufacturing and quality control processes. The firm failed to adequately clean and maintain equipment, establish proper cleaning validation procedures, and ensure complete line clearance. Repeat observations highlight persistent issues with equipment design, quality control unit responsibilities, and labeling controls, indicating a high risk of product contamination and quality defects.