FDA 483 - Rohto-Mentholatum (Vietnam) Co., Ltd. - April 06, 2015

Rohto-Mentholatum (Vietnam) Company, Ltd., an OTC sterile drug manufacturer in Thuan An Town, Binh Duong Province, Vietnam, was cited for significant deficiencies across its manufacturing operations. Observations included inadequate laboratory controls for out-of-specification results and visual inspection, incomplete production record controls, and insufficient validation for aseptic processes and sealing. Furthermore, the firm failed to adequately monitor personnel surfaces and environmental air quality in critical aseptic filling areas.