FDA Inspection 963728 — Janssen Biotech Inc.
The FDA completed an inspection of Janssen Biotech Inc. on February 25, 2016 in Horsham, PA. 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
- February 25, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Horsham, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |