FDA inspection
Simtra US LLC: FDA inspection ending May 12, 2016
FDA inspection 969863 · Voluntary Action Indicated (VAI) · Bloomington, IN
Key facts
| Inspection ID | 969863 |
|---|---|
| Firm | Simtra US LLC |
| FEI number | 1000115571 |
| Address | 927 S Curry Pike |
| City | Bloomington |
| State | IN |
| ZIP | 47403 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | May 12, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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