FDA 483 - SterCUBE Surgical Systems LLC - March 17, 2023

SteriCube, LLC, a manufacturer of Class II Multiple Tray Sterilization Systems in Gulfport, FL, was inspected by the FDA. The inspection revealed one observation concerning inadequately established procedures for corrective and preventive actions (CAPA). Specifically, the firm's CAPA procedure lacked requirements for standardized analysis of quality data and comprehensive documentation of CAPA activities.