US FDA raises concerns about Alexion's Rhode Island Soliris facility

Alexion headquarters in New Haven, Connecticut

The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.

Alexion disclosed the 483 in US Securities and Exchange Commission (SEC) filing last week, explaining that issues raised by the agency relate to “completion and closure of certain investigations, validation of surface sampling methods and monitoring of water systems.”

The firm said it will address the problems detailed in the 483, adding that it will continue to make Soliris at the facility. It also said supplies of the drug will not be interrupted.

An Alexion spokeswoman told us: "The US FDA recently completed a routine current Good Manufacturing Practice (GMP) inspection of our Smithfield, Rhode Island manufacturing facility. 

"At the conclusion of the inspection, the FDA issued a Form 483 with three observations. These observations are inspectional, and do not represent a final FDA determination of compliance. Alexion continues to manufacture Soliris in this facility."

She also said "Addressing [the] FDA observations and advancing quality initiatives is a key priority for Alexion" adding that "We have enhanced, and expect to continually enhance, our overall quality program."


The US Food and Drug Administration (FDA) has raised concerns about the Smithfield facility before.

In 2013, it issued Alexion with a warning letter after inspectors spotted a number of deviations from current good manufacturing practices (cGMP), including the detection of “residues in already-cleaned equipment.”

The US agency reinspected the facility in 2014 issuing Alexion with a second Form 483.

At the time a company spokesman told us "The three observations include a need for enhanced training around gowning procedures, more frequent environmental monitoring, and processes related to identification of the definitive root cause of a prior bioburden excursion."

Alexion stressed that problems highlighted in the new Form 483 are not repeat observations.

According to Alexion's second quarter financials, Soliris - which is used to treat the rare disorders paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) - generated revenue of $701m (€631m) in the three months to the end of June, which up 10% on the year earlier period.

Related News


Alexion ends Moderna mRNA pact

Lonza to set up dedicated manufacturing suite for Alexion

Lonza to set up dedicated manufacturing suite for Alexion

Kanuma is made from GE chicken eggs. Photo - Franck-Boston/iStock

FDA approves Alexion's Kanuma made from GE chicken eggs

Image: iStock/adrian825

Alexion beefs up Soliris IP to help keep biosimilars at bay

Alexion's HQ in Ireland

Lonza take note: Alexion looking to bring more manufacturing in-house

Outside the NICE offices in London, UK

Alexion gives NICE requested Soliris info ahead of July review

US FDA Rebukes Alexion, Pfizer Italian Subsidiary in Warning Letters

US FDA Rebukes Alexion APIs, Pfizer Italian Subsidiary in Warning Letters

NICE recommends Alexion's orphan mAb drug Soliris

NICE result for Soliris, but no justification for high manufacturing costs

Related Products

See more related products