FDA issues warning letter on Genzyme facility
The US Food and Drug Administration has issued a warning letter to Genzyme addressing deficiencies related to the firm's Allston Landing manufacturing facility during an inspection performed in September and October 2008. The letter does not require Genzyme to recall or quarantine product.
Genzyme's partner BioMarin issued a statement, stressing that the news would have no effect on the supply of the co-marketed drug Aldurazyme (laronidase). Biomarin says the firms have sufficient quantities of finished product on hand to meet current demand and can fill additional product at a qualified alternate fill finish supplier.
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