FDA inspection
Tris Pharma Inc.: FDA inspection ending Mar 20, 2017
FDA inspection 1010216 · Official Action Indicated (OAI) · Monmouth Junction, NJ
Key facts
| Inspection ID | 1010216 |
|---|---|
| Firm | Tris Pharma Inc. |
| FEI number | 3004712471 |
| Address | 2033 US Highway 130 |
| City | Monmouth Junction |
| State | NJ |
| ZIP | 08852 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Mar 20, 2017 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 534537 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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