FDA 483 - Matheson Tri-Gas - March 11, 2022

Matheson Tri-Gas in Vernon, CA, was inspected and cited for multiple deficiencies in its manufacturing processes and quality systems for medical grade Oxygen and Nitrogen. Key issues include incomplete performance qualifications, inadequate batch records lacking equipment identification and investigation references, and failures in following and establishing written procedures for change control and annual product reviews. These observations indicate significant gaps in process control, record-keeping, and quality oversight.