FDA Inspection 930456 — Janssen Ortho LLC
The FDA completed an inspection of Janssen Ortho LLC on May 29, 2015 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
- May 29, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gurabo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |