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”.
Genzyme Ireland Limited in Co 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.
Over a nine-day period in January 2026, the FDA inspected the Genzyme facility on the outskirts of Waterford city during which they 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 warning letter to Genzyme in late June, the FDA said the plant’s quality control unit “failed to exercise its responsibility to ensure that drug products are manufactured in compliance with [current good manufacturing practice] and meet established specifications for identity, strength, quality, and purity” as required by FDA regulations.
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The letter states the issues demonstrate a pattern of failure in exercising proper oversight, including in relation to data integrity. The plant failed to keep proper laboratory records and did not thoroughly investigate manufacturing discrepancies or batch failures, it said.
“For example, at the time of the inspection, your firm cancelled numerous deviations without investigating the root cause or assessing product impact.”
The FDA also took issue with Genzyme’s response to the findings from the January report. The firm said it had implemented corrective measures but the FDA said these do not address the “underlying failure of the quality unit” to ensure compliance with regulations.
Under US law, Genzyme’s products are considered “adulterated” because the “methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to [current good manufacturing practice]”, the FDA said.
It added that the introduction of Genzyme products into US interstate commerce “is a prohibited act”.
The FDA said the warning letter is intended to provide the Waterford company an opportunity to address the concerns. It warned that failure to adequately address the issue may result in further action, including seizures or injunctions.
Sanofi purchased Genzyme in 2011 and since then has invested more than €700 million in the Waterford facility. In 2024, the Waterford subsidiary, which is one of the biggest employers in the southeast, recorded revenues €1.65 billion and pretax profits of €328.5 million.
In response to queries, a spokesman for Sanofi said it does not a anticipate any impact on medicines supply “at this time” due to the warning.
“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 spokesman said.
“We will work with the FDA to ensure our action plans fully meet the agency’s requirements and expectations.”
He said all products from the Waterford plant “meet established quality and safety specifications”.
“Sanofi is taking the learnings and feedback from the FDA to further strengthen our existing policies, procedures and controls to ensure the continued safety and quality of our products.
“In addition, we are onboarding significant additional resources to accelerate implementation of the corrective actions, and our quality team are implementing robust, comprehensive controls to ensure rigorous oversight of all ongoing and future manufacturing operations.”
