Medtronic Inc.February 10, 2025

FDA 483 - Medtronic Inc. - February 10, 2025

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Record Details

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.

Company: Medtronic Inc.
Inspection Date: February 10, 2025
Product Type: Device
Office: Minneapolis District Office
Person: Tyler R. Courtney (investigator)

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ID · 041f6c36-79f6-4504-a6d7-5e8ff9a71dbe