# FDA 483 - BioMarin Pharmaceutical, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/biomarin-pharmaceutical-inc/738d34c2-9e7c-4315-95b4-b0dcc2e07b20

> FDA 483 for BioMarin Pharmaceutical, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMarin Pharmaceutical, Inc.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BioMarin Pharmaceuticals, Inc. in Novato, CA, a drug substance and drug product manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included incorrect procedures lacking specific instructions for consistent manufacturing operations, particularly concerning WFI use, cleaning, and storage. Additionally, the firm's process validation for storage conditions was found to be inadequate and lacked specific details.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/thomas-ryan-withers/da48fe05-b8ab-4e47-bc3c-6c4763bb5174)
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Company: https://www.globalkeysolutions.net/companies/biomarin-pharmaceutical-inc/7811b401-4321-4df1-b9b5-deef8905c101

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd