FDA establishment 3014555455, New Taipei City, Taiwan. Part of Leltek Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
FY2018 to FY2027 to date; 1 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Mar 6, 2025 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | None posted | Official Action Indicated (OAI) |
| Product | Charges | Latest |
|---|---|---|
| TRANSDUCER, ULTRASONIC, DIAGNOSTICDevices · 90ITX | Oct 7, 2025 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters
New Taipei City, Taiwan. Part of