FDA 483 - JABIL INC. - September 02, 2022

JABIL INC. in Monument, CO, a contract manufacturer of orthopedic fixation devices, received a Form FDA 483 with three observations. The inspection revealed deficiencies in process monitoring and control for validated processes, inadequate documentation of acceptance activities, and failures in establishing and implementing corrective and preventive actions. These issues indicate significant concerns regarding quality system compliance and device conformity.