FDA hit Sanofi’s Genzyme Ireland Limited with a warning letter on June 22, 2026, escalating a Form 483 the agency issued after inspecting the Waterford facility between Jan. 12 and Jan. 20. The warning letter covers two products: Thymoglobulin, used to prevent and treat acute rejection in kidney transplant patients, and Altuviiio, the Sobi-partnered hemophilia A drug.
The FDA says Genzyme Ireland’s quality unit didn’t ensure lab records captured complete testing data, and skipped documenting multiple non-viable particulate excursion tests. Quality control staff used “uncontrolled Review Checklists” to informally log record reviews, then discarded them. Some updates couldn’t be traced to a specific worker. Sanofi responded to the Form 483 in February and again in April, but the FDA said the fixes never touched the “underlying failure” of quality oversight, including data integrity practices.
Sanofi told Fierce it’s taking “immediate actions” and doesn’t expect any supply disruption.
Genzyme just picked up its second warning letter in under two years. The FDA hit Sanofi’s Framingham, Massachusetts, site with its own warning letter in January 2025, also for weak investigations and inconsistent manufacturing. Two warning letters at two different Genzyme sites in 17 months points to a subsidiary-wide quality culture problem.
Altuviiio is a commercial product with real patients depending on supply, made by a business unit Sanofi paid a little more than $20 billion to acquire back in 2011. Sanofi says it doesn’t anticipate an impact “at this time.” That qualifier is doing work.
— Sarah Chen