CGMP/OTC Finished Pharmaceuticals/Adulterated: FDA Warning Letter to Asanuma Corporation - Sagamihara Factory, June 2, 2026

FDA Warning Letter — Violations FDA cited at Asanuma Corporation - Sagamihara Factory

WARNING LETTER Asanuma Corporation - Sagamihara Factory MARCS-CMS 721136 — June 02, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Reference #: 320-26-84 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Hiroshi Saito Recipient Title General Manager Quality Assurance Department Asanuma Corporation - Sagamihara Factory 1 Chome 14-41 Nishihashimoto, Midori Sagamihara , Kanagawa Japan Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-84 June 2, 2026 Dear Mr. Saito: Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our August 25, 2025, request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Asanuma Corporation - Sagamihara Factory, FEI 3010960168, at 1 Chome 14-41, Nishihashimoto, Midori, Sagamihara, Kanagawa, as well as subsequent correspondence. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)). Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following: 1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 21 CFR 211.84(d)(2)). Your firm manufactures (b)(4) , an OTC (b)(4) drug product labeled to contain the active drug ingredients (b)(4) . This drug product is also labeled and formulated to contain the inactive ingredient talc. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Asbestos is a potential contaminant in talc and is a known human carcinogen when inhaled. 1,2 Your (b)(4) drug product, (b)(4) , is considered a higher-risk drug as it pertains to patient safety regarding asbestos contamination of talc due to the risk of inadvertent inhalation. You have not demonstrated that you appropriately tested incoming talc drug components used in the manufacture of your (b)(4) drug products for identity, purity, strength, and quality. In response to our 704(a)(4) request, you indicate that you did not perform testing for asbestos in talc, and our review found that you do not conduct identity testing on talc prior to use in the manufacture of your drug products. You also failed to provide records indicating that you established the reliability of your supplier’s analyses through appropriate validation of the supplier’s test results. Although 21 CFR 211.84(d)(2) provides for some reliance on a certificate of analysis (COA) from the supplier of the component, such reliance is permissible only if the drug product manufacturer establishes the reliability of the supplier’s test results through appropriate validation of the test results at appropriate intervals. Without adequate testing, you lack scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine, as appropriate, drug components before use in production to ensure acceptable specifications for identity, strength, quality, and purity are met. Because yo