Alexion gets FDA warning over contamination at R.I. plant

ALEXION PHARMACEUTICALS received a warning letter from the U.S. Food and Drug Administration over a bacterial contamination investigation at its Smithfield plant.
Posted 4/1/13

NEW YORK – Alexion Pharmaceuticals was hit with a warning letter from the U.S. Food and Drug Administration over its investigation of bacterial contamination at its Rhode Island facility, reported MarketWatch’s Health Exchange blog.

In a press release last week, Alexion said the letter follows inspections of the facility in August where the company produces Soliris, its treatment for a blood disorder known as paroxysmal nocturnal hemoglobinuria.

Alexion’s Rhode Island facility is located at 100 Technology Way in Smithfield.

According to MarketWatch, Alexion said the FDA sent the warning letter because Alexion did not adequately address issues found during the inspection and it failed to comply with good manufacturing practices.

The company said it believes it has addressed the FDA’s initial concerns and will “work digitintly” to resolve the issues cited in the latest letter.

“Based on current information, we believe that the supply of Soliris to patients will not be interrupted and that the warning letter does not restrict production of Soliris or shipment of Soliris from the Rhode Island facility. We continue to manufacture products, including Soliris, in this facility,” the company said in a statement.

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