FDA Inspection 1252745 — Actelion Pharmaceuticals US Inc.
The FDA completed an inspection of Actelion Pharmaceuticals US Inc. on Oct 28, 2024 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 28, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Titusville, NJ (United States)
Additional Details
Risk Evaluation and Mitigation Strategies (REMS)
Citations
| ID | CFR | Description |
|---|---|---|
| 21355 | FDCA 505-1(f)(3)(B) | Failure to comply with REMS Elements to Assure Safe Use (ETASU) B |
| 21360 | FDCA 505-1(f)(4) | Failure to comply with REMS Implementation System |