# FDA 483 - BioMarin Pharmaceutical, Inc. - April 02, 2021

Source: https://www.globalkeysolutions.net/records/483/biomarin-pharmaceutical-inc/68119bf5-5042-4336-9c03-7fde3f113010

> FDA 483 for BioMarin Pharmaceutical, Inc. on April 02, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMarin Pharmaceutical, Inc.
- Inspection Date: 2021-04-02
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: An FDA inspection of BioMarin Pharmaceutical, Inc. in Novato, CA, a drug substance manufacturer, revealed two significant observations. The firm lacked written procedures for requesting and shipping samples to control laboratories and for receiving, reviewing, and filing test results from contract laboratories. These deficiencies indicate inadequate control over critical quality processes involving external laboratories.

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## Related Officers

- [Hung H. Do](https://www.globalkeysolutions.net/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)
- [Uttaniti Limchumroon](https://www.globalkeysolutions.net/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

Company: https://www.globalkeysolutions.net/companies/biomarin-pharmaceutical-inc/7811b401-4321-4df1-b9b5-deef8905c101

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df