[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-guangdong-bangze-medicine-co-ltd-734509-10262026":3,"fda-latest-sync-dates":30},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":15,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":28,"updated_at":29},22102,"guangdong-bangze-medicine-co-ltd-734509-10262026","Warning Letter","Guangdong Bangze Medicine Co., Ltd.",null,"Center for Drug Evaluation and Research (CDER)","CGMP\u002FFinished Pharmaceuticals\u002FAdulterated","2026-11-03","2026-10-26","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fguangdong-bangze-medicine-co-ltd-734509-10262026","320-27-10","734509","Drugs Over-the-Counter Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","Mr. Yongliang Fang","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv>\n  \u003Cdl>\n\n              \u003Cdt>Delivery Method:\u003C\u002Fdt> \n        \u003Cdd>VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt>Reference #:\u003C\u002Fdt> \n        \u003Cdd>320-27-10\u003C\u002Fdd>\n      \n              \u003Cdt>Product:\u003C\u002Fdt> \n        \u003Cdd>Drugs                          \n            \n            \n            \n            \n                          \u003Cbr>Over-the-Counter Drugs\n                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv>\n  \u003Cdiv>\n    \u003Cdl>\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv>Mr. Yongliang Fang\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv>General Manager\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Guangdong Bangze Medicine Co., Ltd.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>No. 300 Shangfang Avenue\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Simapu Town\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Chaonan Qu\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Shantou Shi\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Guangdong Sheng\u003C\u002Fspan>, \u003Cspan>515149\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>China\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(4)\"> (b)(4)\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv>\n    \u003Cdl>\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research (CDER)\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp>\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl> \n      \n  \u003Cdiv>\n    \u003Cdiv>Secondary Issuing Offices\u003C\u002Fdiv>\n          \u003Cdiv>\n              \u003Cdiv>    \u003Cbr>\n    \n     \n        \u003Cdd>\u003Cp>\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n    \n    \n    \n    \n\u003C\u002Fdiv>\n              \u003C\u002Fdiv>\n      \u003C\u002Fdiv>\n\n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>October 26, 2026\u003C\u002Fp>\u003Cp>\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>Reference number: 320-27-10\u003C\u002Fp>\u003Cp>To Mr. Yongliang Fang:\u003C\u002Fp>\u003Cp>This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your products and records submitted from your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice.\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during review of your drug manufacturing facility, Guangdong Bangze Medicine Co., Ltd., FDA Establishment Identifier (FEI) 3035364398. This review was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.\u003C\u002Fp>\u003Cp>Your facility is registered with the FDA as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our January 20, 2026, request and subsequent correspondence, 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.\u003C\u002Fp>\u003Cp>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).\u003C\u002Fp>\u003Cp>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 FD&C Act (21 U.S.C. 351(a)(2)(B)).\u003C\u002Fp>\u003Cp>\u003Cstrong>Violations of the Federal Food, Drug, and Cosmetic Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations at your facility.\u003C\u002Fp>\u003Cp>\u003Cstrong>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 211.84(d)(2)).\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your firm manufactures OTC drug products including \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Based on the records and information you provided, you did not demonstrate that you adequately tested the identity, purity, or strength of components used in the manufacture of your drug products. You also relied on your suppliers' certificates of analysis (COA) for \u003Cstrong>(b)(4)\u003C\u002Fstrong> without demonstrating the reliability of your suppliers' test analyses at appropriate intervals.\u003C\u002Fp>\u003Cp>\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your incoming inspection records for your \u003Cstrong>(b)(4)\u003C\u002Fstrong> active ingredient failed to include appropriate compendial identity testing, assay, or impurity testing.\u003C\u002Fp>\u003Cp>You manufacture drugs that contain \u003Cstrong>(b)(4)\u003C\u002Fstrong>. The use of \u003Cstrong>(b)(4)\u003C\u002Fstrong> contaminated with \u003Cstrong>(b)(4)\u003C\u002Fstrong> has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document \u003Cstrong>(b)(4).\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your incoming inspection records for your \u003Cstrong>(b)(4)\u003C\u002Fstrong> component similarly failed to include compendial identity testing and lacked appropriate \u003Cstrong>(b)(4)\u003C\u002Fstrong> limit testing. Identity testing for \u003Cstrong>(b)(4)\u003C\u002Fstrong> and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fp>\u003Cp>The use of ingredients contaminated with \u003Cstrong>(b)(4)\u003C\u002Fstrong> has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Based on the records you provided, you did not perform appropriate \u003Cstrong>(b)(4)\u003C\u002Fstrong> testing, including \u003Cstrong>(b)(4)\u003C\u002Fstrong> testing, on the \u003Cstrong>(b)(4)\u003C\u002Fstrong> used to manufacture your drug products. Your \u003Cstrong>(b)(4)\u003C\u002Fstrong> specifications reference the Chinese Pharmacopeia rather than USP for \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Without adequate \u003Cstrong>(b)(4)\u003C\u002Fstrong> testing, you do not have scientific evidence that the \u003Cstrong>(b)(4)\u003C\u002Fstrong> used as a component in your drug product manufacturing conforms to appropriate specifications.\u003C\u002Fp>\u003Cp>Component testing is fundamental to quality. Without adequate testing, you do not have scientific evidence that your 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 drug components before use in production to assure adequate quality.\u003C\u002Fp>\u003Cp>\u003Cstrong>2. 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. Your firm also failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Based on the records and information you provided, you did not demonstrate that you adequately test your OTC finished drug products prior to release for distribution to the United States. Specifically, the certificate of analyses (COA) that you provided did not include identity, assay, or impurity test results. In addition, the COAs provided also reveal that you lacked appropriate testing for objectionable microorganisms for each batch.\u003C\u002Fp>\u003Cp>Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient prior to release and distribution. Without adequate testing, you do not have scientific evidence to assure that your drug products conform to appropriate specifications before release.\u003C\u002Fp>\u003Cp>\u003Cstrong>3. Your firm’s quality unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU failed to ensure:\u003C\u002Fp>\u003Cul>\u003Cli>The establishment of an adequate, ongoing stability program (21 CFR 211.166(a)).\u003C\u002Fli>\u003Cli>Adequate procedures ensuring appropriate production and process controls, including appropriate qualification of the \u003Cstrong>(b)(4)\u003C\u002Fstrong> system (21 CFR 211.100(a)).\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents \u003Cem>Quality Systems Approach to Pharmaceutical CGMP Regulations\u003C\u002Fem> at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71023\u002Fdownload.\u003C\u002Fp>\u003Cp>\u003Cstrong>CGMP Consultant Recommended\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Based upon the nature of the violations we identified in your response, you should engage a consultant qualified as set forth in 21 CFR 211.34, to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.\u003C\u002Fp>\u003Cp>Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventive measures to ensure future and sustained compliance so that these violations and any others do not occur.\u003C\u002Fp>\u003Cp>FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on August 7, 2026.\u003C\u002Fp>\u003Cp>FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any violations.\u003C\u002Fp>\u003Cp>Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Guangdong Bangze Medicine Co., Ltd., No. 300 Shangfang Avenue, Simapu Town, Chaonan District, Shantou, Guangdong, 515149 China, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).\u003C\u002Fp>\u003Cp>Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3035364398 and ATTN: Christopher Jenner in the subject line of the email.\u003C\u002Fp>\u003Cp>If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\u003C\u002Fp>\u003Cp>FDA posts warning letters to www.FDA.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003C\u002Fp>\u003Cp>\u002FS\u002F\u003Cbr>Francis Godwin\u003Cbr>Director\u003Cbr>Office of Manufacturing Quality\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\u003C\u002Fp>\u003Cp>Cc: Registered U.S. Agent\u003Cbr>Frosa Technology, LLC\u003Cbr>\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nReference #:\n\n320-27-10\n\nProduct:\n\nDrugs\n\nOver-the-Counter Drugs\n\nRecipient:\n\nRecipient Name\n\nMr. Yongliang Fang\n\nRecipient Title\n\nGeneral Manager\n\nGuangdong Bangze Medicine Co., Ltd.\n\nNo. 300 Shangfang Avenue\n\nSimapu Town\n\nChaonan Qu\n\nShantou Shi\n\nGuangdong Sheng, 515149\n\nChina\n\n(b)(4)\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nOctober 26, 2026\nWARNING LETTER\nReference number: 320-27-10\nTo Mr. Yongliang Fang:\nThis warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your products and records submitted from your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice.\nFDA Review\nViolations were identified and documented during review of your drug manufacturing facility, Guangdong Bangze Medicine Co., Ltd., FDA Establishment Identifier (FEI) 3035364398. This review was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.\nYour facility is registered with the FDA as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our January 20, 2026, request and subsequent correspondence, 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.\nThis 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).\nBecause 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 FD&C Act (21 U.S.C. 351(a)(2)(B)).\nViolations of the Federal Food, Drug, and Cosmetic Act\nThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations at your facility.\n1. 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 211.84(d)(2)).\nYour firm manufactures OTC drug products including (b)(4). Based on the records and information you provided, you did not demonstrate that you adequately tested the identity, purity, or strength of components used in the manufacture of your drug products. You also relied on your suppliers' certificates of analysis (COA) for (b)(4) without demonstrating the reliability of your suppliers' test analyses at appropriate intervals.\n(b)(4)\nYour incoming inspection records for your (b)(4) active ingredient failed to include appropriate compendial identity testing, assay, or impurity testing.\nYou manufacture drugs that contain (b)(4). The use of (b)(4) contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4).\n(b)(4)\nYour incoming inspection records for your (b)(4) component similarly failed to include compendial identity testing and lacked appropriate (b)(4) limit testing. Identity testing for (b)(4) and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of (b)(4).\nThe use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4)\n(b)(4)\nBased on the records you provided, you did not perform appropriate (b)(4) testing, including (b)(4) testing, on the (b)(4) used to manufacture your drug products. Your (b)(4) specifications reference the Chinese Pharmacopeia rather than USP for (b)(4). Without adequate (b)(4) testing, you do not have scientific evidence that the (b)(4) used as a component in your drug product manufacturing conforms to appropriate specifications.\nComponent testing is fundamental to quality. Without adequate testing, you do not have scientific evidence that your 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 drug components before use in production to assure adequate quality.\n2. 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. Your firm also failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).\nBased on the records and information you provided, you did not demonstrate that you adequately test your OTC finished drug products prior to release for distribution to the United States. Specifically, the certificate of analyses (COA) that you provided did not include identity, assay, or impurity test results. In addition, the COAs provided also reveal that you lacked appropriate testing for objectionable microorganisms for each batch.\nTesting is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient prior to release and distribution. Without adequate testing, you do not have scientific evidence to assure that your drug products conform to appropriate specifications before release.\n3. Your firm’s quality unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).\nThe records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU failed to ensure:\nThe establishment of an adequate, ongoing stability program (21 CFR 211.166(a)).\nAdequate procedures ensuring appropriate production and process controls, including appropriate qualification of the (b)(4) system (21 CFR 211.100(a)).\nYour firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71023\u002Fdownload.\nCGMP Consultant Recommended\nBased upon the nature of the violations we identified in your response, you should engage a consultant qualified as set forth in 21 CFR 211.34, to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.\nYour use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.\nConclusion\nAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventive measures to ensure future and sustained compliance so that these violations and any others do not occur.\nFDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on August 7, 2026.\nFDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any violations.\nFailure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Guangdong Bangze Medicine Co., Ltd., No. 300 Shangfang Avenue, Simapu Town, Chaonan District, Shantou, Guangdong, 515149 China, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).\nSend your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3035364398 and ATTN: Christopher Jenner in the subject line of the email.\nIf you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\nFDA posts warning letters to www.FDA.gov.\nSincerely,\n\u002FS\u002F\nFrancis Godwin\nDirector\nOffice of Manufacturing Quality\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration\nCc: Registered U.S. Agent\nFrosa Technology, LLC\n(b)(4)","2026-11-10T01:02:34.865+00:00",[24,25,26,9,10,27,27,27],"\u003Ctime datetime=\"2026-11-03T05:00:00Z\">11\u002F03\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-10-26T04:00:00Z\">10\u002F26\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fguangdong-bangze-medicine-co-ltd-734509-10262026\">Guangdong Bangze Medicine Co., Ltd.\u003C\u002Fa>","","2026-11-10T01:02:16.121874+00:00","2026-11-10T01:02:35.425684+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"event_backfill":35,"pma":36,"warning_letter":37},"2026-11-09T02:00:35.105+00:00","2026-11-09T02:00:29.052+00:00","2026-11-09T02:00:32.696+00:00","2026-11-12T04:02:32.647+00:00","2026-09-07T05:17:28.839+00:00","2026-11-09T02:00:36.308+00:00","2026-11-10T01:03:48.189+00:00"]