Matheson Tri-Gas, IncDecember 9, 2022

FDA 483 - Matheson Tri-Gas, Inc - December 09, 2022

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Record Details

An FDA inspection of Matheson Tri-Gas, Inc. in Dallas, TX, a medical gas manufacturer, revealed a significant lapse in quality control. The firm failed to conduct annual product reviews for all trans-filled drug products, including Oxygen, USP, Carbon Dioxide, USP, Nitrogen, NF, and Nitrous Oxide, USP. This indicates a failure to maintain records for evaluating product quality and identifying opportunities for continuous process improvement.

Company: Matheson Tri-Gas, Inc
Inspection Date: December 9, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
People: Margaret M. Ames
Kevin T. Nguyen (investigator)
Shanna N. Purdy (Investigator)

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ID · 18491013-fac8-4b88-8469-9edc1ae5d1ab