US drug safety inspectors have warned one of Ireland’s largest pharmaceutical plants that it is failing to meet safety standards and manufacturing “adulterated products”.

According to The Irish Times, Genzyme Ireland Limited in Waterford, the Irish arm of the biopharma giant Sanofi was inspected by officials from the US Food and Drug Administration (FDA) earlier this year.

The plant, which employs over 950 people, is subject to FDA inspections as much of its product is sold in the US.

The FDA found “significant violations” of manufacturing standards.

The issues related specifically to the manufacture of Thymoglobulin, which is used in patients to prevent the rejection of kidney transplants, and Altuviiio, a haemophilia treatment.

In a statement to WLR News, Sanofi said: “Patient safety and the quality of our products are our highest priorities. We take the FDA Warning Letter issued to the Waterford facility with the utmost seriousness. We are taking immediate actions and are committed to fully addressing each of the Agency’s observations, robustly and sustainably.”

The statement adds: “We will work with the FDA to ensure our action plans fully meet the Agency’s requirements and expectations. All products released from the Waterford facility meet established quality and safety specifications. We do not anticipate any impact on our ability to supply medicines at this time.”