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.
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.