FDA to have Genzyme plant inspected, reviewed

CAMBRIDGE, Mass. Genzyme Corp. will have to submit to inspections of one of its plants by the Food and Drug Administration and pay fees to the agency under a consent decree, the biotechnology company said Wednesday.

The FDA will likely hire a third party to inspect and review Genzyme’s plant in the Boston neighborhood of Allston for an extended period of time to ensure its compliance with accepted manufacturing standards. Genzyme will also have to pay the FDA for the inspections, and may have to pay other fees as well.

The action comes as a result of an incident in June 2009, when the company detected a virus that inhibits cell growth in one of the containers it uses to manufacture drugs; the virus, vesivirus 2117, is not known to cause human infection. The company said the virus was the cause of declines in productivity at two of its plants, including Allston, in 2008, and was likely introduced via a nutrient used in the manufacturing process.

In November 2009, the company found particulate matter in supplies of drugs from the Allston plant, particularly the Gaucher disease drug Cerezyme (imiglucerase), the Fabry disease drug Fabrazyme (agalsidase beta), the Pompe disease drug Myozyme (alglucosidase alfa), the mucopolysaccharidosis treatment Aldurazyme (laronidase) and the thyroid disease drug Thyrogen (thyrotropin alfa).

The drug maker said it expected shipments of the Cerezyme, Fabrazyme and Myozyme, which are manufactured at the Allston plant, to continue uninterrupted.

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