FDA inspection
Serim Research Corporation: FDA inspection ending Apr 7, 2022
FDA inspection 1167161 · Voluntary Action Indicated (VAI) · Elkhart, IN
Key facts
| Inspection ID | 1167161 |
|---|---|
| Firm | Serim Research Corporation |
| FEI number | 1833387 |
| Address | 3506 Reedy Dr, Po Box 4002 |
| City | Elkhart |
| State | IN |
| ZIP | 46514 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Apr 7, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 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