FDA Inspection 1236964 — Genentech, Inc.
The FDA completed an inspection of Genentech, Inc. on May 2, 2024 in South San Francisco, 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
- May 2, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- South San Francisco, CA (United States)
Additional details
Risk Evaluation and Mitigation Strategies (REMS)
Citations
| ID | CFR | Description |
|---|---|---|
| 21360 | FDCA 505-1(f)(4) | Failure to comply with REMS Implementation System |