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

During an inspection conducted from November 11-15, 2024, by the U.S. Food and Drug Administration (FDA), HLSCIENCE CO., LTD in Chungju, Korea, received a Form FDA 483 citing significant deficiencies related to manufacturing controls for its (b)(4) OTC drug products. The observations highlight a failure to adhere to current Good Manufacturing Practices (cGMP). Key issues include inadequate laboratory controls, where test methods for active components were not validated, and essential microbial testing procedures lacked proper controls like growth promotion testing. The company failed to establish expiration dates supported by appropriate stability data for its drug products. Furthermore, released product lots were distributed without comprehensive finished product testing, and incoming raw materials lacked identity testing, relying solely on unverified supplier analyses. Additional violations encompass a lack of process validation and equipment qualification for manufacturing and essential systems, such as the (b)(4) system. Equipment cleaning validation and maintenance logs were absent, and a tablet inspection machine was found with damaged product-contact surfaces. The quality control unit lacked written procedures for critical activities like data integrity, change control, investigations, and supplier qualification. Moreover, employees had not received specific cGMP training for pharmaceuticals. Batch production records were found incomplete, missing essential data like yield quantification and labeling specimens. HLSCIENCE CO., LTD is required to implement comprehensive corrective and preventive actions to address these systemic issues, ensuring all manufacturing, testing, and quality processes comply with regulatory standards to guarantee drug product quality, safety, and purity.