FDA 483 - CMIC CMO Korea Co., Ltd. - June 15, 2018

CMIC CMO Korea Co., Ltd., an OTC drug manufacturer in Bucheon-si, Gyeonggi-do, received a Form 483 with six observations. The inspection revealed significant issues across quality control, laboratory operations, stability programs, employee training, and change control. These deficiencies indicate a lack of robust quality systems and data integrity concerns.