Genzyme faces FDA enforcement over plant issues
Genzyme says the Food and Drug Administration will take enforcement action against the biotechnology company after a series of manufacturing problems stalled production of key drugs.
The FDA will likely require that a third party inspect and review plant operations for an extended period of time. Genzyme Corp. would also be required to make payments to the government, the company says.
Last June, the Cambridge, Mass. company shut down its manufacturing plant in Boston to clean up viral contamination that had been slowing down production of two drugs. Then in November, the Food and Drug Administration said it found tiny particles of trash in drugs made by Genzyme, including steel, rubber and fiber.