# FDA 483 - Medtronic Sofamor Danek USA, Inc - February 17, 2022

Source: https://www.globalkeysolutions.net/records/483/medtronic-sofamor-danek-usa-inc/be3dca10-5524-420e-934a-59649fb8bf70

> FDA 483 for Medtronic Sofamor Danek USA, Inc on February 17, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medtronic Sofamor Danek USA, Inc
- Inspection Date: 2022-02-17
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Medtronic Sofamor Danek USA, Inc. in Memphis, TN, a manufacturer of medical devices, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, complaint handling, device history records, process controls, and equipment calibration. These issues indicate a lack of robust controls over critical manufacturing and quality processes.

## Related Officers

- [Jamie P. Webb](https://www.globalkeysolutions.net/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)
- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/medtronic-sofamor-danek-usa-inc/1803c0d5-74d1-4e22-9d2a-65ddba605290

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea