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

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.