FDA 483 - BioMarin Pharmaceuticals, Inc. - September 24, 2013

BioMarin Pharmaceuticals, Inc. in Novato, CA was inspected as a sponsor of a clinical study. The inspection revealed a failure to ensure proper monitoring of the study, specifically concerning a contract research organization's inadequate review of case report forms. This led to a subject being overdosed due to a discrepancy in reported weight and administered study drug volume.