FDA 483 - Matheson Tri-Gas, Inc. - April 05, 2017

An FDA inspection of Matheson Tri-Gas, Inc., a medical gas manufacturer in Bangor, ME, was conducted from April 3-5, 2017. The inspection identified two key observations requiring corrective action to align with the Federal Food, Drug, and Cosmetic Act and Good Manufacturing Practices. The first observation noted inadequate control over rejected and in-process drug product containers. The firm lacked dedicated quarantine areas, leading to critical items like liquid cryogenic dewars needing repair being in trans-filling areas without proper identification. Additionally, carts containing medical gas cylinders requiring repair or re-testing were co-mingled with industrial gas cylinders and other released products, posing a risk of unsuitable containers entering the manufacturing stream. The second observation highlighted a deficiency within the quality control unit, specifically that calibration records were not consistently reviewed as per the firm's own procedures. Nine calibration record entries for an analyzer between January and March 2017 were found to be missing required quality control unit review signatures. Matheson Tri-Gas, Inc. must address these findings by implementing robust corrective actions to ensure proper segregation of medical gas containers and adherence to quality control documentation protocols.