FDA WARNING_LETTER - Asanuma Corporation - Sagamihara Factory - August 01, 2025

The FDA issued a Warning Letter dated June 2, 2026, to Asanuma Corporation - Sagamihara Factory, based in Kanagawa, Japan, following a review of manufacturing records requested in August 2025. The review identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the firm"s over-the-counter drug products adulterated under the Federal Food, Drug, and Cosmetic Act. Key issues include the failure to test raw materials, particularly talc, for identity and purity. Most notably, the firm did not test for asbestos, a hazardous contaminant and known carcinogen. Additionally, the company relied on supplier Certificates of Analysis without conducting necessary validation to ensure the data"s accuracy. The FDA also cited the Quality Control Unit for failing to maintain effective oversight, as evidenced by inadequate specifications for impurities and a lack of scientific rigor in testing protocols. Consequently, the firm was placed on an import alert in January 2026. The FDA requires Asanuma to perform retrospective testing on talc lots or finished products, conduct a gap analysis against United States Pharmacopeia standards, and implement a comprehensive remediation plan to strengthen the Quality Unit"s authority. A written response detailing these corrective actions is required within 15 working days.