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

Kolmar Korea Co., Ltd. - Gwanjeong Factory, a drug manufacturer in Sejong-Si, Korea, was cited for multiple significant deficiencies during an FDA inspection from February 8-16, 2024. The observations highlight severe issues across quality control, production record-keeping, data integrity, and raw material warehousing, indicating a lack of robust controls for OTC drug manufacturing. These deficiencies include inadequate microbial testing, missing batch record documentation, insecure computerized lab systems, and a failure to establish impurity specifications.