FDA Inspection 878913 — Janssen Pharmaceutica NV
The FDA completed an inspection of Janssen Pharmaceutica NV on May 16, 2014 in Olen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Olen (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |