FDA 483 - Kolmar Korea Co., Ltd. - Gwanjeong Factory - February 16, 2024

Kolmar Korea Co., Ltd. - Gwanjeong Factory in Chungcheongnam-Do, Korea, received a Form FDA 483 with six observations during an inspection from February 8-16, 2024. The inspection revealed significant deficiencies in quality control, batch record documentation, data integrity, product traceability, and raw material warehousing for OTC drug products shipped to the US market. These issues indicate a lack of robust quality systems and adherence to good manufacturing practices.