# FDA 483 - Medtronic Xomed, Inc. - June 17, 2024

Source: https://www.keypedia.com/records/483/medtronic-xomed-inc/e7bd616a-2240-44d4-b953-473707d9eac9

> FDA 483 for Medtronic Xomed, Inc. on June 17, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Xomed, Inc.
- Inspection Date: 2024-06-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: During an inspection, Medtronic Xomed, Inc. in Jacksonville, FL, was cited for inadequately established corrective and preventive action procedures. Specifically, an ineffective CAPA related to an EMG tube cuff overinflation complaint demonstrated a failure in root cause analysis and the implementation of effective corrective measures, leading to recurring issues.

## Related Documents

- [483 - 2021-10-29](https://www.keypedia.com/records/483/medtronic-xomed-inc/c5fc974e-0f65-4937-9bb1-e098a68f7e4b)

## Related Officers

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Company: https://www.keypedia.com/companies/medtronic-xomed-inc/1309a87b-9fb3-4260-ba3a-8cb515b17fc4

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6