FDA 483 - JABIL INC. - October 22, 2021

JABIL INC. in Monument, CO, a medical device manufacturer, was inspected by the FDA from October 12-22, 2021. The inspection revealed significant issues related to inadequate process validation for Class II finished devices, deficiencies in corrective and preventive action procedures, and failures in maintaining device master records. These observations indicate a need for improved quality system controls.