FDA Inspection 1063744 — Janssen Ortho LLC
The FDA completed an inspection of Janssen Ortho LLC on August 28, 2018 in Gurabo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 28, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gurabo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |