FDA 483 - Medical Technical Gases, Inc. - October 12, 2023

An FDA inspection of Medical Technical Gases, Inc. in N Billerica, MA, a medical gas manufacturer, revealed significant deficiencies in quality control unit procedures and batch production records. The firm failed to properly follow labeling verification and nitrogen identity testing procedures, and did not control the issuance of medical fill logs. These issues, including repeat observations from a previous inspection, indicate a concerning lack of adherence to established quality and documentation practices.