FDA Takes Enforcement Action at Genzyme Plant

The FDA has notified Genzyme Corp. that it intends to take enforcement action to ensure that products manufactured at the company’s Allston plant are made in compliance with GMP regulations. This action will likely result in a consent decree, under which a third party will inspect and review the plant’s operation for an extended period in order to certify compliance with FDA regulations. Under a consent decree, Genzyme would be required to make payments to the government and could incur other costs.

Genzyme expects that shipments of Cerezyme, Fabrazyme, and Myozyme produced at the 160-L scale, which are manufactured in Allston, will continue uninterrupted during the period of the enforcement action. The company also fills and finishes Thyrogen at the Allston plant and will discuss with the agency the need for uninterrupted supply of this product as well. The discussions with the FDA are expected to occur during the next several weeks.

The company reported that it has taken the following steps in an effort to bring the plant up to the highest standards: retained a quality assurance advisory firm to help develop a comprehensive strategy and risk mitigation plan, named a new site head and reorganized and strengthened the management team at the facility. Genzyme has also hired two industry veterans to serve as president of Global Manufacturing and Corporate Operations and senior vice president of Global Product Quality.