FDA Concerned Over Quality Issues at Alexion's Soliris Facility

Alexion Pharma (NASDAQ: ALXN) disclosed the following on Monday:

The U.S. Food and Drug Administration (FDA) recently completed a routine current Good Manufacturing Practice (GMP) inspection of Alexion Pharmaceutical, Inc.'s (Alexion's) 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.

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