CHEMATICS, INC. – FDA 483, Mar 12, 2020

An FDA inspection of CHEMATICS, INC. in Leesburg, IN, revealed significant deficiencies in their manufacturing processes, particularly concerning the Alco-Screen 02 packaging. The firm failed to adequately validate critical process parameters, control validated process parameters, and establish proper corrective and preventive actions for product complaints, including a repeat observation. These issues indicate a lack of robust quality system controls.