Guangdong Bangze Medicine Co., Ltd.

FDA's Center for Drug Evaluation and Research (CDER) issued Warning Letter Reference No. 320-27-10, dated October 26, 2026, to Guangdong Bangze Medicine Co., Ltd. (FEI 3035364398), a Chinese manufacturer of over-the-counter drug products. The letter follows FDA's review of records submitted in response to a January 20, 2026, request under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA concluded that the facility's manufacturing methods, facilities, and controls do not conform to Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Parts 210 and 211, rendering the firm's drug products adulterated under section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B). The first cited violation, under 21 CFR 211.84(d)(1) and (d)(2), concerns the firm's failure to test incoming drug components for identity, purity, and strength. The firm relied on supplier certificates of analysis without establishing supplier reliability at appropriate intervals. Incoming inspection records for active ingredients and excipients lacked compendial identity testing, assay testing, and required limit testing under United States Pharmacopeia (USP) standards. FDA specifically noted that certain components, if contaminated with particular impurities, have been associated with lethal poisoning incidents in humans worldwide, and that the firm's specifications referenced the Chinese Pharmacopeia rather than USP. The second violation, under 21 CFR 211.165(a) and (b), addresses the firm's failure to perform adequate laboratory testing on finished drug product batches prior to release for U.S. distribution. Certificates of analysis provided to FDA lacked identity, assay, and impurity test results. Batch records also demonstrated the absence of appropriate testing for objectionable microorganisms. The third violation, under 21 CFR 211.22, concerns the firm's quality unit's failure to exercise oversight of manufacturing operations. Specific deficiencies include the absence of an adequate ongoing stability program required under 21 CFR 211.166(a) and inadequate production and process controls, including qualification of a manufacturing system, under 21 CFR 211.100(a). FDA placed all drugs offered for import from this firm on Import Alert 66-40 on August 7, 2026, and stated it may withhold approval of new applications or supplements listing the firm as a drug manufacturer pending CGMP compliance confirmation.