FDA inspection
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC: FDA inspection ending Dec 6, 2017
FDA inspection 1035368 · Voluntary Action Indicated (VAI) · Noblesville, IN
Key facts
| Inspection ID | 1035368 |
|---|---|
| Firm | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC |
| FEI number | 3002183074 |
| Address | 14470 Bergen Blvd Ste 500 |
| City | Noblesville |
| State | IN |
| ZIP | 46060 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Dec 6, 2017 |
| 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