FDA inspection
Somnics, Inc.: FDA inspection ending Jun 5, 2025
FDA inspection 1272457 · Voluntary Action Indicated (VAI) · Xin Zhu Xian
Key facts
| Inspection ID | 1272457 |
|---|---|
| Firm | Somnics, Inc. |
| FEI number | 3014674517 |
| Address | Hsinchu Science Park, 5f, Sec. 2, 22 Shengyi Rd.; Zhubei City |
| City | Xin Zhu Xian |
| Country | Taiwan |
| Fiscal year | 2025 |
| Inspection end date | Jun 5, 2025 |
| 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