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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

SILVER SPRING, Md., May 24 /PRNewswire-USNewswire/ -- Genzyme Corp. has signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and will turn over to the federal government $175 million in unlawful profits from the sale of products that were made at the plant, the U.S. Food and Drug Administration announced today.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Under the consent decree of permanent injunction, the Cambridge, Mass.-based company agreed to adhere to a strict timetable to bring the plant in line with the regulatory requirements of the FDA.

The payment is known as a disgorgement in which a company must give up profits obtained by improper or illegal acts.

The decree was agreed to by Genzyme, its Chief Executive Officer Henri A. Termeer; its Senior Vice President for Manufacturing Sciences and Technical Operations, W. Blair Okita; and its Senior Vice President for Global Product Quality, Ronald Branning. It was filed in the U.S. District Court for the District of Massachusetts on May 24, 2010, and is subject to court approval.

Genzyme is a sole supplier of several enzyme replacement drugs for injection that are used to treat rare genetic di
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SOURCE U.S. Food and Drug Administration
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