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

During an inspection conducted from November 11-15, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to HLSCIENCE CO., LTD, a manufacturer located in Chungju, Chungbuk, Korea. The inspection revealed significant deficiencies concerning the firm's adherence to Current Good Manufacturing Practices (CGMP) for pharmaceutical products.

Key observations highlighted critical lapses in quality control and production processes. The company failed to validate crucial in-house laboratory test methods, such as HPLC assays and microbial growth promotion tests, for raw materials and finished OTC drug products. Furthermore, drug product expiration dates were not supported by adequate stability data, and finished products were released without complete final specification testing.

The inspection also noted a lack of identity testing for incoming raw materials, reliance on unvalidated supplier analyses, and a complete absence of process validation and equipment qualification for manufacturing operations, including an unvalidated (b)(4) system. Equipment cleaning validation was not performed, cleaning logs were missing, and a tablet inspecting machine had visible damage.

Additionally, the quality control unit lacked essential written procedures for data integrity, change control, investigations, supplier qualification, and annual product reviews. Employee training in CGMP was found to be inadequate, and batch production records were incomplete, lacking details like yield quantification and labeling specimens.

HLSCIENCE CO., LTD is required to address these observations comprehensively, implement robust corrective and preventive actions, and ensure all manufacturing and control activities comply with FDA CGMP regulations to assure the identity, strength, quality, and purity of their drug products.