FDA warning letter to Genzyme related to Allston manufacturing facility

BioMarin Pharmaceutical Inc. announced that the FDA warning letter issued to Genzyme addressing deficiencies related to Genzyme's Allston Landing manufacturing facility during an inspection performed in September and October 2008 has no foreseeable impact on the supply of Aldurazyme.

The warning letter does not require Genzyme to recall or quarantine product. BioMarin and Genzyme have sufficient quantities of finished product on hand to meet current demand and can fill additional product at a qualified alternate fill finish supplier. BioMarin is also qualifying a third supplier, which it expects to be approved later this year and has no concerns on maintaining sufficient levels of Aldurazyme inventory. BioMarin does not expect that the situation at the Allston manufacturing facility will have any impact on Aldurazyme sales.

http://www.bmrn.com/