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

Source: https://www.keypedia.com/records/483/biomarin-pharmaceutical-inc/e6630c14-6a99-465e-bfaa-7ffad255012d

> FDA 483 for BioMarin Pharmaceutical Inc. on February 18, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMarin Pharmaceutical Inc.
- Inspection Date: 2014-02-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Documents

- [483 - 2020-02-28](https://www.keypedia.com/records/483/biomarin-pharmaceutical-inc/3b5c0c31-bc6b-4799-8b54-6e93864093fa)

## Related Officers

- [Director - Compliance Branch](https://www.keypedia.com/people/lance-m-de-souza/8445cae5-3104-4159-89e9-e07fb7852270)

Company: https://www.keypedia.com/companies/biomarin-pharmaceutical-inc/73126e34-fd3f-451a-beef-466225ecadc2

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