# FDA 483 - Huons Co., Ltd. - Jecheon Factory - November 21, 2025

Source: https://www.globalkeysolutions.net/records/483/huons-co-ltd-jecheon-factory/a70cc7c8-2a25-41ff-a254-5653e3dfb70f

> FDA 483 for Huons Co., Ltd. - Jecheon Factory on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Huons Co., Ltd. - Jecheon Factory
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Huon Co., Ltd., a sterile drug manufacturer in Jecheon, Korea, was cited for significant data integrity issues, inadequate investigations into product complaints and out-of-specification results, and critical deficiencies in aseptic processing and sterilization validation. These observations indicate a severe lack of control over manufacturing processes and quality systems. This could potentially impact the safety and efficacy of drug products intended for the U.S. market.

## Related Documents

- [483 - 2019-10-18](https://www.globalkeysolutions.net/records/483/huons-co-ltd-jecheon-factory/75c26f5f-004e-41a0-8944-bb85b3e79066)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Eileen A. Liu](https://www.globalkeysolutions.net/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.globalkeysolutions.net/companies/huons-co-ltd-jecheon-factory/a5a38ece-82d5-4f72-908b-d77779e3f91e

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