Genzyme to correct manufacturing quality violations at Mass. plant
SILVER SPRING, Md. Biotech company Genzyme will pay $175 million to the federal government as part of an effort to correct problems at its factory in Allston, Mass., the Food and Drug Administration said Monday.
The FDA announced that Genzyme had signed a consent decree of permanent injunction, agreeing to correct manufacturing quality violations and to adhere to a “strict” timetable to bring the plant in line with regulations. The payment to the government is a disgorgement to make up for profits from drugs made at the factory.
“It is critical for the safety of the drug supply that companies comply with basic manufacturing standards,” FDA principal deputy commissioner Jushua Sharfstein said in a statement. “FDA takes these obligations very seriously and expects manufacturers to do the same.”
During an inspection of the plant between Oct. 8 and Nov. 13, 2009, FDA inspectors found deficiencies in its quality-control systems, leading to shortages and contaminated drugs.
The company is the sole supplier of several enzyme-based biotech drugs used to treat rare genetic disorders. These include Cerezyme (imiglucerase), for Gaucher’s disease, which causes fatty substances to build up around the digestive organs, and Fabrazyme (agalsidase beta), for Fabry disease, which causes oil and fats to build up around the eyes and kidneys, among others.