# FDA 483 - JABIL INC. - September 02, 2022

Source: https://www.keypedia.com/records/483/jabil-inc/26fb8ce2-39e6-4f43-beab-dc0db00d1b31

> FDA 483 for JABIL INC. on September 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JABIL INC.
- Inspection Date: 2022-09-02
- Product Type: device
- Office Name: Denver District Office
- Summary: 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.

## Related Documents

- [483 - 2021-10-22](https://www.keypedia.com/records/483/jabil-inc/735fd4fd-5322-485f-b066-3121e6de3502)

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.keypedia.com/companies/jabil-inc/3fb742ab-83fc-4b09-8d13-c6b3db74a65f

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face