# FDA 483 - Linde Gas & Equipment Inc - July 25, 2025

Source: https://www.globalkeysolutions.net/records/483/linde-gas-equipment-inc/7ad5257a-e2ee-45cb-b346-12a83755a74f

> FDA 483 for Linde Gas & Equipment Inc on July 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Linde Gas & Equipment Inc
- Inspection Date: 2025-07-25
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Linde Gas & Equipment Inc. in Livingston, TN, revealed critical deficiencies in the manufacturing and distribution of its NOxBOXi Class II medical device. The firm demonstrated repeated failures in corrective and preventive actions, inadequate purchasing controls for its critical supplier, and systemic issues in complaint handling that led to unreported adverse events, including patient death and serious injury. Additionally, a significant field correction for device malfunctions was not reported to the FDA, collectively posing ongoing and severe safety risks to critically ill neonatal patients.

## Related Documents

- [483 - 2023-10-19](https://www.globalkeysolutions.net/records/483/linde-gas-equipment-inc/c5e813ed-4699-49a9-aded-721aacc63765)

## Related Officers

- [Jamie P. Webb](https://www.globalkeysolutions.net/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.globalkeysolutions.net/companies/linde-gas-equipment-inc/2624f076-2d0c-463e-9442-a50eb1a68bc1

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