JABIL INC.September 2, 2022

FDA 483 - JABIL INC. - September 02, 2022

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Record Details

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.

Company: JABIL INC.
Inspection Date: September 2, 2022
Product Type: Device
Office: Denver District Office
Person: Christine I. Shaw (investigator)

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ID · 26fb8ce2-39e6-4f43-beab-dc0db00d1b31