# FDA 483 - Matheson Tri-Gas Inc - December 19, 2019

Source: https://www.keypedia.com/records/483/matheson-tri-gas-inc/4ec5dfa6-2146-44d7-9e1a-2edd4ad266d7

> FDA 483 for Matheson Tri-Gas Inc on December 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Matheson Tri-Gas Inc
- Inspection Date: 2019-12-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Matheson Tri-Gas, Inc. in Richmond, CA, was cited for significant data integrity issues during an FDA inspection. The firm's laboratory records for Nitrous Oxide, USP, were found to be incomplete, lacking proper review of raw chromatography data and justification for unreported injections. Furthermore, the inspection revealed disabled system audit trails, the use of shared administrator accounts, and inappropriate access levels for personnel involved in production, analysis, and batch release, compromising data reliability.

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/matheson-tri-gas-inc/7207fe61-0e01-48f1-8320-0c64151e9d01

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b