# FDA 483 - BioMarin Pharmaceutical Inc. - February 28, 2020

Source: https://www.keypedia.com/records/483/biomarin-pharmaceutical-inc/3b5c0c31-bc6b-4799-8b54-6e93864093fa

> FDA 483 for BioMarin Pharmaceutical Inc. on February 28, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMarin Pharmaceutical Inc.
- Inspection Date: 2020-02-28
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: BioMarin Pharmaceutical Inc. in San Rafael, CA, was cited during an FDA inspection for deficiencies in its pharmacovigilance processes. The firm failed to submit all annual periodic adverse drug experience reports within the required 60 days of the application's anniversary date. Specifically, three periodic adverse event reports were submitted late to the agency.

## Related Documents

- [483 - 2014-02-18](https://www.keypedia.com/records/483/biomarin-pharmaceutical-inc/e6630c14-6a99-465e-bfaa-7ffad255012d)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/dipti-kalra/0d2a1f50-3052-4a81-8cad-f1a9a82b4a72)
- [Investigator ](https://www.keypedia.com/people/dustin-tran/52b41643-a5f9-4b2e-8da4-24beca42b1cd)
- [issuing_officer](https://www.keypedia.com/people/haley-h-seymour/721a8937-0b2d-418c-bc8f-daa827ae6b92)
- [investigator](https://www.keypedia.com/people/stephen-t-hansen/7ae1f1df-7f68-4264-bd87-ea21c8d879bb)
- [issuing_officer](https://www.keypedia.com/people/karen-m-montgomery/ee91b1bb-8d51-4fdc-bee5-949441136e59)

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