FDA 483 - Rohto-Mentholatum (Vietnam) Co., Ltd. - November 01, 2019

An FDA inspection of Rohto-Mentholatum (Vietnam) Co., Ltd. revealed significant deficiencies across multiple areas of sterile drug product manufacturing. Key issues included inadequate environmental monitoring in aseptic processing, insufficient process validation, and a failure to thoroughly investigate out-of-specification results. Additionally, the firm demonstrated poor computer system controls, deficient laboratory testing procedures, and an incomplete disinfectant efficacy study, indicating a broad lack of adherence to good manufacturing practices.