FDA 483 - Matheson Tri-Gas, Inc. - June 04, 2026
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An FDA inspection of Nippon Sanso Matheson, Inc. in Lawton, OK, a medical gas manufacturer, revealed two significant observations. The firm's computerized systems for medical gas manufacturing, processing, and holding were not appropriately validated, specifically failing to retain electronic source data from analyzers. Additionally, the second-person review process for Certificates of Analysis was deficient, as CoAs were not reviewed against source data prior to product release.
ID · 8525f8bc-ffc2-4268-8aa6-e71458437462