FDA 483 - Florida Cirtech Inc - June 08, 2021

An FDA inspection of Florida Cirtech Inc, a drug product manufacturer in Greeley, CO, revealed significant deficiencies in its quality control systems. The firm failed to establish appropriate specifications for hand sanitizer, did not adequately qualify raw material suppliers, and lacked proper procedures for handling and investigating product complaints and adverse events. These issues indicate a serious lack of control over product quality and safety.