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

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Food and drug administration

Alexion headquarters in New Haven, Connecticut
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.

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