# FDA 483 - JABIL INC. - October 22, 2021

Source: https://www.globalkeysolutions.net/records/483/jabil-inc/735fd4fd-5322-485f-b066-3121e6de3502

> FDA 483 for JABIL INC. on October 22, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JABIL INC.
- Inspection Date: 2021-10-22
- Product Type: device
- Office Name: Denver District Office
- Summary: 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.

## Related Documents

- [483 - 2022-09-02](https://www.globalkeysolutions.net/records/483/jabil-inc/26fb8ce2-39e6-4f43-beab-dc0db00d1b31)

## Related Officers

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

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

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