FDA 483 - Kolmar Korea Co. Ltd. - July 05, 2019

Kolmar Korea Co. Ltd., an OTC drug manufacturer in Sejong-si, Korea, received a Form 483 with seven observations during an FDA inspection. The inspection revealed severe deficiencies in quality control unit oversight, data integrity, record-keeping practices, complaint investigations, and employee training. These issues indicate a systemic failure to adhere to cGMP regulations, with several observations being repeats from previous inspections.