FDA inspection
Janssen Cilag Manufacturing LLC: FDA inspection ending Nov 23, 2021
FDA inspection 1158642 · Voluntary Action Indicated (VAI) · Gurabo, PR
Key facts
| Inspection ID | 1158642 |
|---|---|
| Firm | Janssen Cilag Manufacturing LLC |
| FEI number | 3006244497 |
| Address | State Road 933 Km. 0.1, Mamey Ward |
| City | Gurabo |
| State | PR |
| ZIP | 00778 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Nov 23, 2021 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data