FDA 483 - BioMarin Pharmaceutical Inc. - February 18, 2014

An FDA inspection of BioMarin Pharmaceutical, Inc. in San Rafael, CA, a drug manufacturer, revealed a significant deficiency in their pharmacovigilance system. The firm failed to develop written procedures for the surveillance of post-marketing adverse drug experiences. This oversight resulted in specialty pharmacies, which dispense their products like Kuvan and Naglazyme, not being audited for pharmacovigilance compliance, potentially leading to unreported adverse drug experiences.