# FDA 483 - Medtronic Navigation, Inc. - June 29, 2021

Source: https://www.keypedia.com/records/483/medtronic-navigation-inc/42917bc7-112a-4777-b1e7-9b5d9027e7dd

> FDA 483 for Medtronic Navigation, Inc. on June 29, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Navigation, Inc.
- Inspection Date: 2021-06-29
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Medtronic Navigation, Inc. in Louisville, CO, revealed significant deficiencies in their quality system. The firm failed to revalidate processes after changes, particularly concerning a supplier's process for biopsy needle depth stops, which led to a product recall. Additionally, risk analyses were found to be inadequate, and corrective and preventive action procedures were not adequately established or followed.

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## 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