# FDA 483 - Medtronic Inc. - February 10, 2025

Source: https://www.keypedia.com/records/483/medtronic-inc/041f6c36-79f6-4504-a6d7-5e8ff9a71dbe

> FDA 483 for Medtronic Inc. on February 10, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Inc.
- Inspection Date: 2025-02-10
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: The FDA inspected Medtronic, Inc. in Mounds View, MN, from January 22 to February 10, 2025, and issued a Form 483. The inspection revealed a significant deficiency in the firm's documentation of corrective and preventive action (CAPA) activities. Specifically, the firm failed to adequately record all considerations and rejections of potential causes during a CAPA investigation related to nonconformances.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.keypedia.com/companies/medtronic-inc/41386b1c-ad8d-48e3-ab53-fdfbdcab10aa

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d