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

Source: https://www.keypedia.com/records/483/biomarin-pharmaceuticals-inc/4314fb42-5a5a-4411-83dc-24fc844b0b13

> FDA 483 for BioMarin Pharmaceuticals, Inc. on September 24, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMarin Pharmaceuticals, Inc.
- Inspection Date: 2013-09-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [Government Employee](https://www.keypedia.com/people/aneel-k-sandhu/426b5d36-5c58-4f2e-ae8c-7076f8f52029)

Company: https://www.keypedia.com/companies/biomarin-pharmaceuticals-inc/9a0d49a4-3cbf-427a-b72f-0281eb48ddfd

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b