FDA Inspection 1119195 — BioMarin Pharmaceutical Inc.
The FDA completed an inspection of BioMarin Pharmaceutical Inc. on February 28, 2020 in San Rafael, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Rafael, CA (United States)
Additional Details
Risk Evaluation and Mitigation Strategies (REMS)
Citations
| ID | CFR | Description |
|---|---|---|
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |