# FDA 483 - Leltek Inc. - March 06, 2025

Source: https://www.keypedia.com/records/483/leltek-inc/86d405b8-1b9b-4d32-88e4-b7bed59359fd

> FDA 483 for Leltek Inc. on March 06, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Leltek Inc.
- Inspection Date: 2025-03-06
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2025-03-06](https://www.keypedia.com/records/warning_letter/leltek-inc/a2c55ba2-4aa8-4795-9ca6-f81e5c71e354)

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/leltek-inc/72511bac-313b-4774-adbf-d12ddf42cd96

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8