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FDA action on Genzyme's Allston Plant

Genzyme has announced that the US Food and Drug Administration will take enforcement action on its plant in Allston, Massachusetts

Genzyme has announced that the US Food and Drug Administration (FDA) will take enforcement action on its plant in Allston, Massachusetts, to ensure products are made in compliance with good manufacturing practice regulations.

Although the US-based drugmakers expect to continue the manufacture of products at the plant, including top sellers Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta), the action will likely result in production having to follow a consent decree. This means a third party would inspect and review the plant's operations for an extended period of time, making sure the plant is following FDA regulations.

Under such a decree, Genzyme would have to make payments to the government and could incur other costs.

The decision follows a series of "significant deviations from current good manufacturing practice" discovered during FDA regulatory inspections dating back to 2008. The results of these issues have already seen the plant close for three months in 2009 to clean up viral contamination that had been affecting production of Cerezyme and Fabrazyme.

In an unrelated incident, foreign particles were also detected in some products at the plant during a routine quality control process in November. These included non-latex rubber originating from the stopper, stainless steel particles and fibre-like material.

Genzyme said: "[The company] will work cooperatively with the FDA to restore the agency's confidence in its ability to operate the Allston plant at the highest standards, building on the progress it has made over the past year to address the manufacturing deficiencies at the Allston plant."

The financial impact on Genzyme has yet to be disclosed.

25th March 2010

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