Leltek Inc. – FDA Inspection, Mar 6, 2025

Record Details

This FDA Inspection record concerns Leltek Inc., with an inspection on March 6, 2025, issued by the Center for Devices and Radiological Health, covering devices.

Company: Leltek Inc.
Inspection Date: March 6, 2025
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Thai T. Duong (Issuing Officer)

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ID · dfee7b16-d3a5-4da5-b763-0335a83e9bc8

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1266113
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued, view the record

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FDA Inspection

Leltek Inc.March 6, 2025