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My DashboardInspection TrackerWarning LettersLeltek Inc.

All Warning Letters

Leltek Inc.

Warning LetterOpen

6F.-3, 293 Beixin Road, Section 1 Xindian District , New Taipei City 23147 TaiwanIssued Jul 17, 2025Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations17

Issue DateJul 17, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Leltek Inc.
Location: 6F.-3, 293 Beixin Road, Section 1 Xindian District , New Taipei City 23147 Taiwan
FEI Number: N/A
Country: Taiwan
Issue Date: July 17, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

CGMP/QSR/Medical Devices/Adulterated

Leltek Inc. FDA Warning Letter, July 17, 2025