SURETEC INNOVATIONS LLC – FDA 483, Mar 5, 2026

An FDA inspection of SURETEC INNOVATIONS LLC in Gilbert, AZ, revealed critical deficiencies in its quality control unit and laboratory operations. The firm failed to ensure drug products were manufactured in accordance with current good manufacturing practices (cGMP), including issues with equipment qualification, method validation, and proper product release procedures. These findings indicate a severe lack of oversight and control over essential manufacturing and testing processes.