Medtronic Inc.February 10, 2025

FDA 483 - Medtronic Inc. - February 10, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Medtronic Inc.

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)

Open in Dashboard

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