FDA 483 - Hanlim Pharm Co., Ltd. - February 06, 2018

An FDA inspection of HanLim Pharm Co., Ltd. in Yonginsi Ceoin-gu, Korea, a sterile OTC drug manufacturer, revealed multiple significant deficiencies. These included failures in aseptic processing procedures, inadequate validation of sterilization processes, and insufficient laboratory controls for product specifications. The firm also exhibited issues with data integrity, personnel training for critical operations, and environmental monitoring in aseptic areas, indicating a broad lack of control over manufacturing processes designed to ensure product sterility and quality.