Genzyme Signs Consent Decree With U.S.

Genzyme has signed a consent decree agreeing to correct manufacturing quality problems at its Allston, Mass., facility. In 2009, it halted some production after finding reactors contaminated with a virus. An FDA inspection later found problems that led to products contaminated with metal, fiber, rubber, and glass particles. Genzyme will pay the U.S. government $175 million and move final production steps for its Cerezyme, Fabrazyme, Myozyme, and Thyrogen enzyme replacement products out of the plant. The company also must conduct a two- to three-year-long remediation program, under FDA approval and overseen by the consulting group Quantic, to improve quality and compliance at the facility. A U.S. District Court in Massachusetts must still approve the decree.