The US Food and Drug Administration has notified Genzyme Corporation (Cambridge, MA) that it intends to take enforcement action to ensure that products manufactured at its Allston, MA, plant are made in compliance with good manufacturing practice regulations. The FDA enforcement action will likely result in a consent decree, under which a third party would inspect and review the plant's operation for an extended period and certify compliance with FDA regulations. Under the consent decree, Genzyme also would be required to make payments to the government and could incur other costs.
Based on its initial communication with the agency and the medical need for patients, Genzyme expects that shipments of Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta), which are manufactured in Allston, will continue uninterrupted during the period of the enforcement action. In addition, Genzyme expects that shipments of Myozyme (alglucosidase alfa) produced at the 160-L scale, which is filled and finished in Allston, will continue uninterrupted. The discussions with the FDA are expected to occur over the next several weeks.
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