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

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.