Genzyme meets FDA milestone for Allston plant

Wed, 11/24/2010 - 7:34am
Mass High Tech: The Journal of New England Technology

Genzyme Corp. has met an FDA consent decree milestone, ending its Allston plant's fill/finish operations of four drugs sold in the U.S. The drugs – Cerezyme, Myozyme, Fabrazyme and Thyrogen – are now filled by an outside contract manufacturer and at the biotech’s Waterford, Ireland-based plant for the U.S. market.

The end of the Allston plant’s fill/finish operations follows a series of setbacks for the Cambridge-based biotech, beginning with warning letters about two years ago from the FDA over quality control. FDA inspections later resulted in a six-week shutdown of the plant in 2009  and the discovery of foreign materials in drugs produced at the Allston plant in 2009.  The FDA has since hit Genzyme with hefty financial penalties.



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