FDA 483 - JO Cosmetics Co., Ltd. - October 26, 2018

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from October 25-26, 2018, JO Cosmetics Co., Ltd., located in Ota, Tokyo, Japan, received a Form FDA 483. This document outlined observations made by FDA investigators regarding the company's manufacturing processes for over-the-counter (OTC) drug products. Two primary issues were identified. Firstly, the company lacked established written procedures for the cleaning and maintenance of critical equipment and utensils, such as spatulas and scoops, used within the production and raw material weighing rooms for drug product manufacturing. This absence of documented protocols is a significant concern for maintaining sanitation and preventing contamination. Secondly, the firm's batch production and control records were found to be inadequate. Specifically, these records failed to accurately identify the major equipment utilized during the production of their OTC drug products. These observations indicate potential gaps in adherence to Good Manufacturing Practices, which are essential for ensuring the quality, safety, and efficacy of drug products. JO Cosmetics Co., Ltd. is expected to address these findings by developing and implementing comprehensive corrective actions to resolve the noted deficiencies and ensure full compliance with regulatory standards.