Genzyme Corp. has agreed to fix quality violations at its Allston, Mass., manufacturing facility and turn over $175 million, the U.S. Food and Drug Administration announced Monday. The $175 million payment is known as disgorgement, in which a company must give up profits obtained by illegal or improper acts.
Under the consent decree it signed, Genzyme agreed to adhere to a strict timetable to bring the plant into compliance with FDA regulatory requirements.
During an inspection from Oct. 8, 2009, to Nov. 13, 2009, FDA inspectors found systems for ensuring manufacturing quality at the Allston plant were inadequate, and led to production delays, critical shortages of medically necessary products to consumers, and drugs contaminated with metal, fiber, rubber and glass particles. Additionally, Genzyme temporarily suspended manufacturing some products due to a viral contamination in a bioreactor.
Genzyme is a sole supplier to several enzyme replacement drugs used to treat rare genetic disorders, the FDA said.
Genzyme has agreed to a plan for making facility improvements and will have to pay a substantial fine if it fails to complete any steps in the work plan, the FDA said. The plan includes Genzyme selecting an independent expert to inspect the plant and issue recommendations, and creating a work plan using the experts recommendations, subject to FDA approval. The company must take specific steps for bringing the Allston plant into compliance within given dates.
Additionally, the consent decree gives a deadline for Genzyme to transfer operations for filling drug vials from the Allston plant to other sites or else give up additional profits from sales of drugs made at the Allston plant.