FDA inspection
Leltek Inc.: FDA inspection ending Mar 6, 2025
FDA inspection 1266113 · Official Action Indicated (OAI) · New Taipei City
Key facts
| Inspection ID | 1266113 |
|---|---|
| Firm | Leltek Inc. |
| FEI number | 3014555455 |
| Address | Xindian District, 6 F.; 3 No. 293, Sec. 1, Beixin Rd. |
| City | New Taipei City |
| Country | Taiwan |
| Fiscal year | 2025 |
| Inspection end date | Mar 6, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None 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