FDA Inspection Items For Genzyme's Allston Plant Appear Minor
This article was originally published in The Pink Sheet Daily
Executive Summary
Letter specifying need for re-inspection cites equipment maintenance concerns, review of viral contamination remediation.
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As summer turns to fall, Genzyme is trying to place the viral contamination problems at its Allston Landing, Mass., plant in the rear-view mirror. Both Cerezyme and Fabrazyme are back in production after a July shutdown that caused shortages of the two drugs. Cerezyme is the only approved therapy for Gaucher disease, while Fabrazyme is the only U.S.-approved drug for Fabry disease.
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