Matheson Tri-Gas, Inc. – FDA 483, Jul 8, 2026

During an inspection of Nippon Sanso Matheson, Inc. in Kapolei, Hawaii, the FDA observed significant failures in the firm's quality control unit regarding medical gas manufacturing. These issues included a lack of written procedures for a new process, failure to implement management of change control, and inadequate training for personnel, all impacting the quality assurance of bulk medical gas. The firm also failed to follow proper notification procedures for non-conformance and out-of-specification events.