FDA 483 - Sage Products, LLC - June 07, 2019

Sage Products Inc in Cary, IL was inspected by the FDA from June 3-7, 2019, resulting in two observations. The inspection revealed significant issues with the firm's quality and laboratory systems. Specifically, the firm failed to adequately investigate unexplained discrepancies and critical alarms, and deviations from laboratory procedures were not properly recorded or justified.