FDA 483 - Huons Co., Ltd. - Jecheon Factory - October 18, 2019

Huons Co., Ltd., a sterile drug manufacturer in Jecheon, Korea, was cited for significant deficiencies across its laboratory and quality systems. Observations included inadequate computer system controls leading to data integrity concerns, scientifically unsound laboratory test procedures, and poor documentation practices for environmental monitoring and method verification. Additionally, the firm's environmental monitoring program for aseptic areas was found deficient, and an Out of Specification investigation was inadequately reviewed, with OOS results being rejected without proper corrective actions.