FDA inspection
Ikonisys Inc.: FDA inspection ending Dec 10, 2024
FDA inspection 1256478 · Voluntary Action Indicated (VAI) · New Haven, CT
Key facts
| Inspection ID | 1256478 |
|---|---|
| Firm | Ikonisys Inc. |
| FEI number | 3005566046 |
| Address | 5 Science Park Ste 1000 |
| City | New Haven |
| State | CT |
| ZIP | 06511 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Dec 10, 2024 |
| 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