FDA 483 - HLSCIENCE CO., LTD - November 15, 2024

An FDA inspection conducted at HLSCIENCE CO., LTD in Chungju, Chungbuk, Republic of Korea, from November 11-15, 2024, revealed significant deviations from Current Good Manufacturing Practices (CGMP) for pharmaceutical manufacturing. The inspection identified nine critical observations that require the company's immediate attention and corrective action. Key issues included a lack of validated laboratory controls, specifically unvalidated HPLC assay methods for raw materials and finished drug products, and missing growth promotion testing for culture media. The firm also failed to establish expiration dates for its over-the-counter drug products based on appropriate stability data. Additionally, essential finished product testing was omitted prior to lot release, and incoming raw materials were not adequately identity-tested, relying instead on unvalidated supplier analyses. Further observations highlighted a pervasive absence of critical written procedures for production and process controls, including process and equipment validation, and validation of the water system. Cleaning validation for non-dedicated equipment was absent, as were cleaning and use logs. The Quality Control Unit exhibited deficiencies such as the lack of a data integrity procedure, inadequate audit trail review for HPLC systems, and missing procedures for change control, investigations, and supplier qualification. Employee training in CGMP was found to be insufficient, and batch production records were incomplete, lacking crucial yield information and labeling specimens. A damaged tablet inspecting machine was also noted. HLSCIENCE CO., LTD is required to respond to these observations by detailing comprehensive corrective and preventive actions to ensure full compliance with FDA regulations and safeguard product quality and safety.