FDA Inspection 988929 — Janssen Pharmaceuticals, dba Actelion Pharmaceutical
The FDA completed an inspection of Janssen Pharmaceuticals, dba Actelion Pharmaceutical on September 21, 2016 in South San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2016
- Fiscal Year
- 2016
- 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 |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |