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

An FDA inspection of Hanlim Pharm Co., Ltd., a sterile OTC drug manufacturer located in Yonginsi Ceoin-gu, Gyeonggi-do, Korea, was conducted from January 29 to February 6, 2018. This inspection, carried out under the regulatory framework of Current Good Manufacturing Practices (CGMP) for sterile drug products, identified several critical observations related to manufacturing and quality control systems. Major issues included a failure to follow aseptic procedures designed to prevent microbiological contamination during sterile filling, such as improper operator movements and material handling within Grade A areas. The validation of sterilization processes was found to be inadequate, specifically concerning training for media fill inspectors and documentation practices. Laboratory controls were deficient, with a lack of appropriate specifications for impurities, osmolality, packaging leachables, and preservative effectiveness for various sterile solutions and ointments. Data integrity concerns were raised due to back-dated records, premature data entry, and insufficient security for electronic data, including unlocked time/date functions and administrator privileges for QC staff. Furthermore, employee training for visual inspectors did not accurately reflect production conditions, and environmental monitoring within aseptic processing areas, particularly Restricted Access Barrier Systems, was deemed insufficient. Hanlim Pharm is expected to address these observations with comprehensive corrective and preventive actions to ensure compliance with regulatory standards for sterile drug manufacturing.