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Alexion Pharmaceuticals Inc. (ALXN) Gets FDA Warning Over Contamination at RI Plant


3/29/2013 7:27:26 AM

Alexion Pharmaceuticals said Thursday it received a warning letter from the U.S. Food and Drug Administration over the company’s own investigation of bacterial contamination at a Rhode Island facility. In a press statement, Alexion said the letter follows inspections of the facility in August where Alexion produces Soliris, a treatment for a blood disorder known as paroxysmal noctural hemoglobinuria. The life-threatening disorder destroys red blood cells. Shares of Alexion were off 2.5% at $91.67. The company said the FDA sent the warning because Alexion apparently did not adequately address issues brought up after the inspections and its failure to comply with good manufacturing practices. Manufacturing deficiencies found in the August inspection also turned up during a probe a year earlier, the company said. Alexion said it believes it has adequately addressed the agency’s initial concerns and will “work diligently” to resolve further issues cited in the FDA’s latest letter.

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