Genzyme - Contamination Incidents

Contamination Incidents

In June 2009, Genzyme's Allston, Massachusetts plant was shut down to correct a viral contamination (Vesivirus 2117). A similar event had occurred in 2008 at the Geel, Belgium facilities. By April 2010 it had restarted operation at diminished capacity.

In November 2009, fragments of stainless steel, rubber, and fiber-like material were discovered in some of Genzyme's drugs. The FDA found these materials in Cerezyme, Genzyme's treatment for Gaucher disease, a rare genetic disorder that can lead to life-threatening organ damage. The FDA is permitting the drug to stay in the market, due to a lack of adverse events, and a critical need for the product.

Supplies of Fabrazyme, Genzyme's treatment for Fabry disease, have been rationed to one-third the recommended dose prompting patients to file a petition asking for a license to produce Fabrazyme by other manufacturers to make up the deficit under the Bayh–Dole Act.