FDA 483 - JO Cosmetics Co., Ltd. - October 24, 2018

An FDA inspection of JO Cosmetics Co., Ltd. in Hanyu, Japan, identified four significant deficiencies related to current good manufacturing practices for drug products. The firm failed to provide adequate GMP training to employees, did not fully follow quality control unit procedures including annual product quality reviews, neglected to visually examine reserve samples for deterioration, and lacked proper documentation for laboratory test procedures.