FDA 483 - Kolmar Korea Co., Ltd. Bucheon Factory - December 06, 2024

The FDA inspection of Kolmar Korea Co., Ltd. revealed significant deficiencies in their manufacturing of OTC drug products, primarily concerning laboratory controls and quality unit procedures. The firm failed to thoroughly investigate discrepancies and out-of-specification results, lacked proper verification of test methods, and maintained incomplete laboratory records. Additionally, the quality control unit's responsibilities were not adequately defined or followed, impacting data review, change control, and sampling processes.