FDA Inspection 599116 — Janssen Pharmaceuticals, dba Actelion Pharmaceutical
The FDA completed an inspection of Janssen Pharmaceuticals, dba Actelion Pharmaceutical on July 20, 2009 in South San Francisco, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 20, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- South San Francisco, CA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |