FDA Warning Letter to a US Manufacturer of Medical Gases

The FDA inspected a US medical gas manufacturer's production facility in Pennsylvania in March 2024 and identified significant GMP violations. Medical gases, as defined by the FDA, are gaseous products used for therapeutic purposes, usually for respiratory support, as anaesthetics or in surgical applications. They must be manufactured and filled in accordance with GMP guidelines to ensure safety and efficacy.

The FDA describes the following deficiencies in the August 2024 Warning Letter:

• Lack of identity testing: the manufacturer did not perform identity testing on purchased gases such as oxygen (Oxygen USP) and nitrogen (Nitrogen NF) and relied on certificates of analysis from suppliers. 
• Inadequate release testing: Complete tests were not performed to verify the purity, identity and content of the medical gases before they were released. 
• Inadequate calibration of production equipment: Key equipment such as pressure and vacuum gauges and oxygen analysers were not regularly calibrated. Some devices had not been checked since November 2020, even though production continued. 
• Incorrect documentation: Employees did not record manufacturing and test results correctly. In some cases, test results were documented without the corresponding tests actually being carried out or the required devices being available.
• Insufficient inspection of container closures: Container closure defects (such as leaking valves) have been repeatedly identified that have not been adequately investigated. These defects jeopardise the integrity of the gases and could increase the risk of patient harm, for example through hypoxia or fire hazard. 
• Weak Quality Unit: The company's quality assurance did not adequately check batches and did not ensure that they met the required quality standards in terms of identity, purity and labelling before they were released.

"These violations concern critical areas of production and quality assurance that significantly increase the risk to the safety and efficacy of the medical gases produced", the FDA writes. This is remarkable as the US manufacturer describes itself on its website as an 'FDA certified supplier' of medical gases.

The FDA called on the company to urgently rectify these deficiencies and recommended the involvement of an external GMP consultant to ensure compliance with regulatory requirements.

To find out more, please see the detailed Warning Letter to the US Manufacturer of medical Gases on the FDA website.