FDA 483 - JO Cosmetics Co., Ltd. - May 22, 2025

JO Cosmetics Co., Ltd. in Hanyu, Japan, was cited for significant deficiencies in its quality control and data integrity systems during an FDA inspection. Observations included a failure to investigate manufacturing discrepancies, inadequate controls for microbial contamination, poor computer system security, and a lack of annual visual examination of reserve samples. These issues indicate a general lack of adherence to good manufacturing practices.