Novo Nordisk and biosimilar developer Alvotech are both contending with renewed regulatory pressure over manufacturing practices at facilities with troubled inspection histories.
The U.S. Food and Drug Administration this week disclosed concerns raised during recent visits to a pair of manufacturing sites, spanning locations from Indiana to Iceland.
Novo Nordisk’s Bloomington, Indiana facility has drawn FDA attention over record-keeping shortfalls and lackluster control procedures over production processes, among other cited issues.
The Danish drugmaker acquired the Bloomington plant through its parent company Novo Holdings, which purchased contract drug manufacturer Catalent in 2024, bringing the site into the Novo fold.
Ongoing problems at the Indiana facility have been directly linked to a string of recent FDA drug rejections, compounding reputational pressure on the company over its manufacturing standards.
Among the rejections tied to the plant is a Complete Response Letter handed to Incyte’s PD-1 inhibitor Zynyz as a first-line treatment for non-small cell lung cancer, a significant commercial setback.
Third-party manufacturing sites are typically kept anonymous when companies and the FDA communicate production-related drug rejections, but Novo’s Indiana plant has been named explicitly in several cases.
That unusual transparency has produced a string of negative production headlines for the company, drawing sustained investor and industry attention to the state of its newly acquired facilities.
Meanwhile, Alvotech’s Reykjavik, Iceland manufacturing facility faced a separate FDA inspection, concluded on May 8, 2026, resulting in the issuance of a Form 483 citing observations at the site.
Alvotech has stated it believes the observations can be addressed quickly and do not raise substantial issues with the site or its operations, projecting a path toward swift resolution.
The company said it remains well positioned to resubmit the relevant Biologics License Applications during the current quarter, after final data are compiled, continuing to expect FDA approval for these BLAs during 2026.
Both companies now face the task of demonstrating to regulators that remediation efforts are credible and timely, as manufacturing reliability remains a critical factor in the drug approval process.