Alexion Gets FDA Warning Over Contamination At RI Plant

Law360, Washington (March 28, 2013, 7:52 PM EDT) -- Alexion Pharmaceuticals Inc. was hit with a U.S. Food and Drug Administration warning letter Wednesday over a bacterial contamination investigation and other shortfalls at its Rhode Island manufacturing plant.

The company produces its only FDA-approved drug, the blood disorder treatment Soliris, at the facility, but could shut down manufacturing or shipment processes as it addresses the plant's shortfalls.

According to a U.S. Securities and Exchange Commission filing by Alexion, the FDA inspected the Rhode Island facility in August and determined the company's investigation into bacterial contamination...
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