FDA 483 - Rohto-Mentholatum (Vietnam) Co., Ltd. - April 14, 2026

Rohto-Mentholatum (Vietnam) Co., Ltd., an OTC drug manufacturer, was inspected and found to have significant deficiencies across its aseptic processing operations. Observations included widespread failures in following procedures to prevent microbial contamination, unreliable laboratory and cleaning records, inadequate validation of aseptic processes, and insufficient investigation into product discrepancies. These issues indicate a severe lack of control over sterile manufacturing and quality assurance.