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

The FDA issued a Form 483 to JO Cosmetics Co., Ltd. following two inspections conducted between October 22-26, 2018, across its Komatsudai and Omorinishi facilities in Japan. The inspections revealed multiple deficiencies related to Good Manufacturing Practices (GMP) for over-the-counter (OTC) drug products.Key violations at the Komatsudai facility included a lack of adequate GMP training for employees and insufficient documentation for on-the-job training of quality control analysts. The quality control unit also failed to ensure that all relevant department heads participated in annual product quality reviews. Additionally, reserve samples of OTC drug products had not been visually examined for deterioration in approximately ten years, and laboratory controls lacked proper documentation for HPLC test injections. At the Omorinishi facility, observations highlighted the absence of written procedures for cleaning and maintaining production equipment and areas. Furthermore, batch production records for OTC drug products were found to be deficient as they did not identify the major equipment used during manufacturing. These issues indicate a need for significant improvements in the company's quality systems, personnel training, laboratory controls, and documentation practices to ensure compliance with regulatory standards for drug product manufacturing. JO Cosmetics Co., Ltd. must implement corrective actions and provide a formal response to the FDA addressing these observations.