Rohto Pharmaceutical Company Ltd. – FDA Warning Letter, Apr 14, 2026

In a warning letter dated October 14, 2026, the FDA detailed significant manufacturing and marketing violations by Rohto Pharmaceutical Co., Ltd. following an inspection of its Vietnam facility from April 6 to 14, 2026. The agency found the firm in breach of the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice (CGMP) regulations. A critical issue identified was systemic data falsification; the company repeatedly documented environmental monitoring and equipment cleaning that never occurred, undermining the quality and safety of its sterile ophthalmic products. Additionally, inspectors observed poor aseptic practices, such as the reintroduction of exposed sterile components into the production line and inadequate cleanroom behavior. The FDA also noted that Rohto failed to properly investigate visible particles found in drug batches and marketed several eye drop products with unapproved medical claims, such as treating "digital eye strain" and "UV damage," which fall outside the permitted regulatory framework for over-the-counter drugs. Furthermore, the company used misleading labeling that suggested official FDA endorsement. Consequently, Rohto has suspended manufacturing for the U.S. market and initiated a voluntary product recall. To regain compliance, the company must hire independent experts to conduct a comprehensive data integrity investigation, perform a full risk assessment of distributed products, and implement extensive corrective actions to remediate its laboratory and manufacturing systems.