Alexion Pharma (ALXN) Receives FDA Form 483 for Smithfield, RI, Facility
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Alexion Pharma (NASDAQ: ALXN) disclosed the following on Monday:
Item 8.01 Other Events.
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 observations pertain to: completion and closure of certain investigations, validation of surface sampling methods, and monitoring of water systems. As previously disclosed, Alexion received an FDA Warning Letter, dated March 22, 2013, regarding compliance with current GMP at the Rhode Island facility. None of the observations in the current Form 483 were designated as a repeat observation.
Addressing FDA observations and advancing quality initiatives continues as a key priority for Alexion and Alexion has enhanced and expects to continually enhance its overall quality program. Alexion will work diligently to address the observations identified in the current Form 483.
Alexion continues to manufacture products, including Soliris® (eculizumab), in this facility. Based on current information, Alexion anticipates that the supply of Soliris to patients will not be interrupted.
Further, based on current information, Alexion does not anticipate there will be any material financial impact to address the observations and resolve outstanding FDA concerns.
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