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FDA Won't OK Drug Until Allston Plant Problems Fixed

This article is more than 11 years old.

Federal regulators say they'll hold off on approving a Genzyme drug to treat an enzyme disorder until the pharmaceutical firm fixes several problems at its Allston manufacturing plant.

The FDA says there are problems with equipment maintenance and with procedures Genzyme uses to limit contamination.

Genzyme tells the Boston Herald it's working to clear up the problems in the next three to six months.

This program aired on March 11, 2009. The audio for this program is not available.

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