FDA 483 - Kolmask Co., Ltd. - September 27, 2024

Kolmask Co., Ltd. in Namdong-gu Incheon, South Korea, was inspected by the FDA, resulting in four observations. The inspection revealed deficiencies in cleaning and maintenance procedures, lack of validation for microbial test methods, issues with representative sampling of drug products, and incomplete master production and control records for water usage. These findings indicate potential concerns regarding the quality and control of OTC drug product manufacturing.