BioMarin Pharmaceutical Inc. FDA Inspection Record
BioMarin Pharmaceutical Inc. is an FDA-registered facility (FEI 3004079983) located in Novato, CA, US. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE. RegDataLab tracks 12 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Jun 9, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 12 (8 VAI, 4 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 9, 2026 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 26, 2025 | No Action Indicated (NAI) | No citations listed |
| Aug 19, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 14, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
| Nov 4, 2016 | No Action Indicated (NAI) | No citations listed |
| Apr 17, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 24, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 28, 2013 | No Action Indicated (NAI) | No citations listed |
| Nov 3, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 15, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
FDA record score
11 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
8 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Jun 9, 2026 | 6 x 1 | 6 |
| Inspection classified VAI | Aug 19, 2024 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Dec 14, 2017 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Apr 17, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Sep 24, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Nov 3, 2011 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jul 15, 2010 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Mar 20, 2009 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- BioMarin Pharmaceutical, Inc.
- Location
- Novato, CA (US)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE
- Source
- decrs