FDA 483 - Rohto-Mentholatum (Vietnam) Co., Ltd. - March 16, 2018

An FDA inspection of Rohto Mentholatum (Vietnam) Co., Ltd. in Binh Duong Province, Vietnam, revealed significant deficiencies in the manufacturing of OTC sterile drug products. The firm's environmental monitoring, aseptic processing controls, media fill simulations, and microbiological testing procedures were found to be inadequate. These issues collectively indicate a lack of robust controls necessary to ensure the sterility and quality of their sterile drug products.