483
BioMarin Pharmaceuticals, Inc.FDA 483 - BioMarin Pharmaceuticals, Inc. - September 24, 2013
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Record Details
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.
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ID · 4314fb42-5a5a-4411-83dc-24fc844b0b13