FDA Inspection
BioMarin Pharmaceutical, Inc.BioMarin Pharmaceutical, Inc. – FDA Inspection, Mar 20, 2009
Record Details
This FDA Inspection record concerns BioMarin Pharmaceutical, Inc., with an inspection on March 20, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 20, 2009
- Product Type
- Drugs
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ID · b0b2683c-c2b9-45d8-9aab-a56cd5a7295a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 578239
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Extent of discrepancy, failure investigations
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Other FDA inspections of BioMarin Pharmaceutical, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2025 | Not classified | San Francisco District Office | |
| August 19, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2018 | Not classified | San Francisco District Office | |
| December 14, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for BioMarin Pharmaceutical, Inc.
- FDA Inspection 1268309 - 2025-03-26
- FDA Inspection 1251795 - 2024-08-19
- FDA Inspection 1076844 - 2018-11-09
- FDA Inspection 1041169 - 2017-12-14
- FDA Inspection 991276 - 2016-11-04
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