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Genzyme Corp. Signs Consent Decree to Correct Violations at Allston, Mass., Manufacturing Plant and Give up $175 Million in Profits
Date:5/24/2010

sorders. During an inspection of the Allston plant from Oct. 8, 2009, until Nov. 13, 2009, FDA inspectors found that the company's systems for ensuring manufacturing quality were inadequate resulting in production delays, critical shortages of medically necessary products to consumers and drugs contaminated with metal, fiber, rubber and glass particles. These manufacturing problems violated the FDA's regulations for manufacturing practice. Genzyme also temporarily suspended manufacturing of some products due to a viral contamination in a bioreactor that makes bulk amounts of its drugs. This resulted in additional drug shortages.

"It is critical for the safety of the drug supply that companies comply with basic manufacturing standards. FDA takes these obligations very seriously and expects manufacturers to do the same," said Joshua Sharfstein, M.D., FDA principal deputy commissioner.

Cerezyme, Fabrazyme, Myozyme, and Thyrogen are drug products that undergo all or some stages of manufacture at the Allston plant. Cerezyme treats Gaucher's disease, which causes fatty substances to accumulate in the liver, spleen and other organs. Fabrazyme treats Fabry disease, which prevents the body from breaking down oils and fats that build up in the eyes and the kidneys. Myozyme treats Pompe disease, a muscular disorder, and Thyrogen is used to diagnose thyroid cancer.

Genzyme has agreed to a work plan for making facility improvements. It begins with selecting, within 10 days of entry of the decree by the court, an independent expert who will inspect the plant and issue recommendations. Genzyme will use the expert's recommendations to create a work plan, subject to FDA approval, that requires specific steps for bringing its '/>"/>

SOURCE U.S. Food and Drug Administration
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