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Genzyme Warned Over Procedures At Drug Plant

Law360 (March 10, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has threatened to withhold approval of Genzyme Corp.'s drug shipments and to delay approval of its drug Lumizyme, a treatment for Pompe disease, after inspections revealed “significant deviations” from manufacturing protocols at a Massachusetts plant.

The FDA's warning letter detailing those deviations, sent to Genzyme on Feb. 27, was posted to the agency's Web site on Tuesday. They were discovered during a routine inspection of the company's manufacturing facility in Allston, Mass., in September and October 2008.

The letter cited...
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