FDA 483 - Kolmar Korea Co., Ltd. - Gwanjeong Factory - July 07, 2022

An FDA inspection of Kolmar Korea Co., Ltd. - Gwanjeong Factory in Chungcheongnam-Do, Korea, revealed a significant issue regarding the stability testing of OTC drug products. The firm failed to adequately test batches to determine appropriate expiration dates, specifically by not conducting ongoing stability studies after initial testing. This indicates a lapse in quality control practices for drug product shelf-life determination.