FDA Inspection 1119195 — BioMarin Pharmaceutical Inc.
The FDA completed an inspection of BioMarin Pharmaceutical Inc. on Feb 28, 2020 in San Rafael, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 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 |