FDA WARNING_LETTER - Leltek Inc. - March 06, 2025

Leltek Inc., located in New Taipei City, Taiwan, received a warning letter from the FDA following an inspection conducted between March 3 and March 6, 2025. The inspection identified significant quality system violations regarding the company’s LU700 and LK128 series ultrasound imaging systems. The FDA determined these devices are adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations (CFR), specifically Parts 820 and 803.

Key violations include a failure to implement corrective and preventive actions (CAPA) despite hardware repair rates exceeding 55%. The firm also failed to properly investigate complaints involving serious safety concerns—such as probe overheating and abnormal power consumption—frequently misclassifying these incidents as simple repairs. Other major issues involved inadequate oversight of contract manufacturers, missing Design History Files for specific models, and the use of pre-filled testing forms that lacked data for critical components like lithium batteries. Furthermore, Leltek lacked standardized procedures for reporting adverse events to the FDA as required by medical device reporting regulations.

The FDA deemed Leltek’s initial responses inadequate because they lacked retrospective risk assessments, evidence of employee training, and specific completion timelines. Leltek must submit a written response within 15 business days outlining the corrective actions taken to address these systemic failures. The response must include a detailed timetable for implementation and documentation showing how the firm will prevent future recurrences to ensure compliance with federal safety and quality standards.