Nippon Sanso Matheson, Inc. – FDA 483, Apr 5, 2017

Matheson Tri-Gas, Inc., a medical gas manufacturer in Bangor, ME, was inspected by the FDA from April 3-5, 2017. The inspection revealed two significant issues: inadequate control of rejected drug product containers and failure of the quality control unit to follow its own procedures for reviewing calibration records. These observations indicate deficiencies in the firm's quality system.