Genzyme to pay $175M, agrees to FDA requirements for fixing drug manufacturing problems

FDA fines Genzyme $175M for manufacturing problems

WASHINGTON — Biotech drugmaker Genzyme Corp. has agreed to pay a $175 million penalty to federal regulators in connection with a series of problems at a key manufacturing plant.

The Food and Drug Administration says the company signed a legal agreement to fix contamination problems at its Allston, Mass., facility.

In June, the company shut down the plant for about three months to clean up viral contamination that had been slowing production of the drugs Cerezyme and Fabrazyme. In November, the FDA says it found tiny particles of trash in drugs made by Genzyme, including steel, rubber and fiber.

Drugs made at the Allston plant are used to treat rare inherited diseases, including Gaucher disease.

Genzyme shares fell 50 cents to $48.91 in afternoon trading.