Leltek Inc. – FDA 483, Mar 6, 2025

An FDA inspection of Leltek Inc., a medical device manufacturer in New Taipei City, Taiwan, revealed widespread deficiencies across its quality system. The firm failed to establish adequate procedures for design control, corrective and preventive actions, complaint handling, purchasing controls, process controls, and labeling. Additionally, the company did not maintain proper device history records, provide required information to the GUDID, or develop written Medical Device Reporting procedures, indicating significant non-compliance with regulatory requirements.