# FDA 483 - Medtronic Navigation, Inc. - February 09, 2024

Source: https://www.keypedia.com/records/483/medtronic-navigation-inc/2257c687-308f-4fb5-8038-1dc088a57884

> FDA 483 for Medtronic Navigation, Inc. on February 09, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Navigation, Inc.
- Inspection Date: 2024-02-09
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Medtronic Navigation, Inc. in Lafayette, CO, revealed significant quality system deficiencies, particularly in corrective and preventive actions (CAPA), design verification, and purchasing controls. The firm failed to adequately establish CAPA procedures, leading to ineffective investigations and software releases prior to corrective action completion, and also had inadequate design verification documentation. Additionally, the firm did not qualify a contracted entity for software design control assessment, and this is a repeat observation regarding CAPA from a previous inspection.

## Related Documents

- [483 - 2021-06-29](https://www.keypedia.com/records/483/medtronic-navigation-inc/42917bc7-112a-4777-b1e7-9b5d9027e7dd)

## Related Officers

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

Company: https://www.keypedia.com/companies/medtronic-navigation-inc/db526b6e-13be-4d9c-9a9b-d2bfa6db5ddf

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