Warning Letter Record: Macau-Union Pharmaceutical Limited (May 29, 2026) — Nonprescription/OTC

FDA Warning Letter — Violations FDA cited at Macau-Union Pharmaceutical Limited

WARNING LETTER Macau-Union Pharmaceutical Limited MARCS-CMS 724506 — May 29, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Kin Va Choi Recipient Title General Manager Macau-Union Pharmaceutical Limited 3 - 3A Rua Cinco Do Bairro Da Areia Preta Room B 1/F, Industrial Veng Fong Macao SAR China Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-83 May 29, 2026 Dear Mr. Choi: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Macau-Union Pharmaceutical Limited, FEI 3011219786, at 3-3A Rua Cinco Do Bairro Da Areia Preta, Room B 1/F, Industrial Veng Fong, from December 15 to 17, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding 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). In addition, “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a), 331(d). Additionally, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below. We reviewed your February 2, 2026, response to our Form FDA 483 in detail. CGMP Violations During our inspection, our investigators observed specific violations including, but not limited to, the following. 1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and 211.165(b)). Your firm did not adequately test your over-the-counter (OTC) drug products prior to release and distribution to the U.S. market. Specifically, your firm failed to test the identity and strength of each active ingredient before releasing the drug products. Your firm also failed to perform adequate microbiological testing on each batch of your drug products prior to release. You confirmed to our investigator that you lacked procedures for testing your finished drug products, and you could only provide evidence of finished drug product testing for appearance and weight. In your response, you commit to requiring testing for all drug products for the U.S. market, including identity verification, assay, microbial limits, and critical quality attributes. You also included summary test reports for batches shipped to the U.S. These reports contained both chemical and microbial test results. Your response is inadequate because you failed to provide supporting documentation for corrective actions. Additionally, the analytical reports provided lack specifications and show results for your active ingredients (b)(4) . The analyses found that these active ingredients were below the drug product labeled concentrations but offered no scientific justification or explanation. Sub potency versus the labeled concentration is also a violation of section 501(c) in that the drug produ