FDA Inspection 1338168 — Janssen Pharmaceuticals, Inc
The FDA completed an inspection of Janssen Pharmaceuticals, Inc on Sep 25, 2026 in Titusville, NJ. 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
- Sep 25, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Titusville, NJ (United States)
Additional Details
Risk Evaluation and Mitigation Strategies (REMS)
Citations
| ID | CFR | Description |
|---|---|---|
| 21357 | FDCA 505-1(f)(3)(D) | Failure to comply with REMS Elements to Assure Safe Use (ETASU) D |