Shares of biotech firm Genzyme fell 4 percent to $55.25 in afternoon trading on Wednesday after the Food and Drug Administration informed company they must hire a third-part inspector to ensure quality-control standards.
Genzyme (GENZ) made the announcement that recurring production difficulties at its Allston, Mass. plant led to and FDA ruling to take "enforcement action." The enforcement action entails something the FDA refers to as a consent degree or third party inspections that the company would have to finance in the form of payments to the government.
The financial consequences of the declaration are not yet known executives said Wednesday on a conference call. This is the latest among a litany of problems for the Allston plant. In 2009, Genzyme ceased production out of necessity, causing global shortages of its biggest sellers, Cerezyme and Fabrazyme.
The company assures that the FDA demands will not cause the Gaucher and Fabry disease medications to fall out of production a second time.
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