www.fdanews.com/articles/122245-genzyme-plant-faces-second-contamination-issue-in-five-months
Genzyme Plant Faces Second Contamination Issue in Five Months
November 16, 2009
Several orphan drugs manufactured at Genzyme’s Allston, Mass., facility may be contaminated with foreign particles — the
second contamination issue at the plant in five months. The particles, which may be found in less than 1 percent of the affected products, include stainless
steel fragments, nonlatex rubber from the vial stopper and fiber-like material from the manufacturing process, according to an FDA notice last week.
Drug Industry Daily
Drug Industry Daily