行政处罚决定书文号：沈皇市监处罚﹝2025﹞178号处罚类别：罚款;没收违法所得处罚决定日期：2025-09-04处罚内容：1、没收违法所得21.00元； 2、罚款5000.00元。罚款金额(万元)：0.5违法行为类型：行政违法违法事实：销售“缬沙坦胶囊”未能提供药品的合法购进相关票据、供货方资质材料处罚依据：依据《药品管理法》第一百二十九条处罚机关：沈阳市皇姑区市场监督管理局处罚机关统一社会信用代码：11210105MB05402774数据来源单位：沈阳市皇姑区市场监督管理局数据来源单位统一社会信用代码：11210105MB05402774

行政处罚决定书文号：沈皇市监处罚﹝2025﹞177号处罚类别：罚款;没收违法所得处罚决定日期：2025-09-04处罚内容：1、没收违法所得48.00元； 2、罚款5000.00元。罚款金额(万元)：0.5违法行为类型：行政违法违法事实：销售1盒“稳心颗粒”未能提供购进票据和供货方资质材料。处罚依据：依据《药品管理法》第一百二十九条处罚机关：沈阳市皇姑区市场监督管理局处罚机关统一社会信用代码：11210105MB05402774数据来源单位：沈阳市皇姑区市场监督管理局数据来源单位统一社会信用代码：11210105MB05402774

行政处罚决定书文号：沈皇市监处罚﹝2025﹞176号处罚类别：罚款;没收违法所得处罚决定日期：2025-09-04处罚内容：1、没收违法所得26.00元； 2、罚款5000.00元。罚款金额(万元)：0.5违法行为类型：行政违法违法事实：销售2盒“阿托伐他汀钙片”未能提供购进票据和供货方资质材料。处罚依据：依据《药品管理法》第一百二十九条处罚机关：沈阳市皇姑区市场监督管理局处罚机关统一社会信用代码：11210105MB05402774数据来源单位：沈阳市皇姑区市场监督管理局数据来源单位统一社会信用代码：11210105MB05402774

　　按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据郑州惠普瑞医疗器械有限公司申请，现注销郑州惠普瑞医疗器械有限公司的《药品经营许可证》（证书编号：豫AA3719506）。　　特此公告。　　附件：郑州惠普瑞医疗器械有限公司《药品经营许可证》有关信息表　　2025年9月10日企业名称企业法人（负责人）质量负责人经营方式经营范围经营地址仓库地址证书编号郑州惠普瑞医疗器械有限公司王晓华张睿欣批发体外诊断试剂（药品）(含冷藏药品)***河南省郑州市市辖区郑东新区永平路48号绿业元1号楼1-9层213郑州市航空港经济综合实验区华夏大道与东海路交叉口智能终端（手机）产业园A24号楼四层407室、408室《药品经营许可证》（证号：豫AA3719506）

因你公司在国家局飞行检查中发现质量管理体系存在质量安全风险、依据《医疗器械监督管理条例》第六十七条规定，责令你公司自即日起停产整改。青海省药品监督管理局 2025年9月10日

根据《中华人民共和国行政许可法》第七十条和《药品生产监督管理办法》（国家市场监督管理总局令第28号）第二十条之规定，依企业申请，经我局研究决定，依法注销保定市环东医用制氧厂的《药品生产许可证》。 特此公告。附件：《药品生产许可证》注销名单(共计1家）河北省药品监督管理局2025年9月9日序号企业名称许可证编号社会信用代码法定代表人企业负责人质量负责人生产地址和生产范围注销原因1保定市环东医用制氧厂冀2016002491130606106054699P蒲娟蒲娟张学超保定市竞秀区康庄路615号:医用气体（医用氧（分装））***企业申请

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:25-HFD-45-09-01Product:DrugsRecipient:Shirish M. Gadgeel, M.D.2799 West Grand BoulevardDetroit,MI48202-2608United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 25-HFD-45-09-01Dear Dr. Gadgeel:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between August 5 and August 23, 2024. Investigator Dina A. Tallman, representing FDA, reviewed your conduct of the following clinical investigations:Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4)Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4).Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4).This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, Investigator Tallman presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your September 13, 2024, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated September 13, 2024, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312) governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:1. You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plan for Protocol(b)(4)required you to ensure that subjects met all eligibility criteria before enrollment. Additionally, the investigational plan for Protocol(b)(4)required you to remove from treatment subjects who met certain protocol-defined criteria.You failed to adhere to these requirements. Examples of these failures include, but are not limited to, the following:a. The investigational plan for Protocol(b)(4)required you to ensure that subjects met all inclusion criteria before enrollment, including documentation of an(b)(4). Subject(b)(6)was enrolled in Protocol(b)(4)without confirming the subject’s documentation of an(b)(4). Specifically, the subject’s August 24, 2019,(b)(4)report instead documented an(b)(4). Despite not meeting this inclusion criterion, Subject(b)(6)was enrolled and started study drug on August 3, 2021. This subject continued to receive study drug through November 16, 2021, thus receiving up to at least Cycle 6 of study drug.In your September 13, 2024, written response to the Form FDA 483, you stated that although you had discussions with the medical monitor before enrollment regarding the subject’s eligibility and you were advised that the subject should be eligible, you acknowledge that there is no documentation from the medical monitor or study sponsor regarding this discussion. You also stated that during the FDA inspection, you contacted the current medical monitor, who stated that this subject did not meet this eligibility requirement.As part your corrective and preventive actions, you stated that upon determination of ineligibility by the study sponsor, the IRB was notified, the sponsor unlocked the electronic data capture (EDC), and the EDC was updated to note that the subject did not meet eligibility requirements. You further stated that the following additional corrective and preventive actions were taken: (1) refresher training for research center staff and hematology/oncology providers on source documentation, research best practices, and protocol compliance and good clinical practice; (2) hiring additional research staff to review study eligibility before the clinical investigator’s review; (3) requesting that all eligibility criteria pertaining specifically to the results of genetic reports, and that may be subject to some degree of medical interpretation, be reviewed, confirmed, and approved by the study sponsor; and (4) revision of “prescreening/screening/eligibility workflow” to ensure that screening and eligibility assessments are timely and systematic.b. The investigational plan for Protocol(b)(4)required you to remove from treatment any subjects with confirmed disease progression as defined by modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria, or any subjects with disease progression accompanied by worsening of symptoms or deterioration of the subject’s general condition. Subject(b)(6), who was enrolled in Protocol(b)(4), had confirmed disease progression as defined by RECIST 1.1 criteria, according to the subject’s September 16, 2021, and November 9, 2021, tumor measurement reports, thereby meeting the protocol’s requirements for removal from treatment. However, Subject(b)(6)continued to receive intravenous infusions of the investigational drug(b)(4), and was not removed from study treatment for progressive disease until January 3, 2022.In your September 13, 2024, written response to the Form FDA 483, you stated that the protocol version dated February 5, 2021 (effective at the time of first progression), did not specify whether treatment beyond progression was or was not permissible. As a result, the research center contacted the sponsor to determine if treatment beyond disease progression was permissible, and the sponsor approved continued dosing. You further stated that subsequent protocol amendments included information regarding treatment beyond disease progression, stating that such treatment would be permissible if certain conditions were met.While we acknowledge your statement that the sponsor approved the continued dosing, based on the information provided, we note that the sponsor did not approve the continued dosing until November 23, 2021. However, Subject(b)(6)had confirmed disease progression beginning on September 16, 2021, and received the investigational drug on October 12, 2021, and November 9, 2021, before any sponsor approval of continued dosing.Additionally, while your response states that subsequent protocol amendments allowed for treatment beyond disease progression, we note that the protocol version in effect at the time of the subject’s treatment clearly specifies that subjects with confirmed disease progression, as defined by modified RECIST 1.1 criteria, will be removed from treatment. It was not until the protocol version dated March 22, 2023, that an option to continue treatment beyond disease progression is allowed for subjects who have clinical benefits, according to the investigator’s judgment and with sponsor approval.As part of your written response, you stated that the following corrective and preventive actions were taken, including but not limited to: (1) reporting the treatment beyond progression to the IRB; (2) development of and training of research staff on a Treatment Beyond Progression workflow, which requires staff to determine if treatment beyond progression is permissible according to the protocol; or if treatment beyond progression is not addressed in the protocol, requiring approval from the sponsor and the IRB before it would be permissible; and (3) development of and training of research staff on a RECIST Measurement workflow.We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. Your failure to ensure that all study-related procedures were followed, including protocol required eligibility requirements and stopping rules for treatment discontinuation, raises significant concerns about your protection of the study subjects enrolled at your site, and raises concerns about the validity and integrity of the data collected at your site.2. You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20].As a clinical investigator, you are required to obtain informed consent in accordance with 21 CFR part 50. FDA’s regulations at 21 CFR 50.20 state that, except as provided in 21 CFR 50.23 and 21 CFR 50.24, no investigator may involve a human being as a subject in research covered by the regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.You failed to obtain legally effective informed consent for Subject(b)(6), who was enrolled in Protocol(b)(4). Specifically, the protocol required subjects to sign a separate special consent for inherited genetic analysis. The IRB approved the separate consent for optional genetic analysis on January 10, 2021. However, for Subject(b)(6), a separate consent was not obtained before collecting blood samples for genetic analysis at two timepoints: Cycle 2, Day 1 (on May 25, 2021) and Cycle 3, Day 1 (on June 15, 2021).In your September 13, 2024, written response to the Form FDA 483, you stated that due to staff oversight, staff failed to confirm that consent was obtained from the subject before collecting the optional samples at two timepoints. You also stated that if the correct test kit had been used on Cycle 3, Day 1, instead of an unscheduled test kit, there would not have been an option to collect the sample. You further stated that the following corrective and preventive actions were taken: (1) research center staff alerted the sponsor and requested destruction of the blood samples when the oversight was initially discovered in 2022, and the IRB was notified; (2) the laboratory supervisor created a new workflow to prevent recurrence of this issue, which includes a system of mandatory double-checks by the research nurse and research assistant before optional specimen sample collection, and re-review of the informed consent form to ensure that optional samples have been consented to; (3) revision of the study visit document template, to address whether study samples are part of the study protocol and whether the subject has agreed to optional samples; (4) staff retraining on the appropriate lab kit inventory management process, and when to use unscheduled lab kits; and (5) revision of the flowsheet for tracking lab specimen collection for research subjects, for completion by the study coordinator or research nurse to indicate, before specimens are collected, which optional samples the subject has agreed to.We emphasize that as the clinical investigator, you are responsible for ensuring that informed consent is obtained from subjects, in accordance with 21 CFR part 50. Your failure to obtain informed consent before conducting study-related procedures jeopardizes the safety and welfare of subjects by denying them an opportunity to fully assess the risks and benefits of their participation in the clinical investigation.While we acknowledge the corrective and preventive actions that your site has taken, your response is inadequate because you did not include sufficient details about your corrective action plan. For example, your written response does not provide sufficient details about how you, as a clinical investigator, will ensure adequate oversight of study procedures (for example, adherence to eligibility requirements and informed consent requirements). Without these details, we are unable to determine whether your corrective action plan is adequate to prevent similar violations in the future.We emphasize that as the clinical investigator, you are ultimately responsible for compliance with all applicable FDA regulations governing the conduct of clinical investigations and the protection of human subjects, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. Your failure to conduct the clinical studies in accordance with the protocol, and your failure to obtain legally effective informed consent before involving subjects in research, raise significant concerns about your protection of the study subjects enrolled at your site and raise concerns about the validity and integrity of the data collected at your site.This letter is not intended to be an all-inclusive list of deficiencies with your clinical studies of investigational drugs. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Should you have any questions or concerns regarding this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov.Your written response and any pertinent documentation should be addressed to:Brittany L. Garr-Colón, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely yours,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------DAVID C BURROW09/04/2025 01:36:34 PM

　　按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据企业申请，现注销南阳安一信大药房连锁有限公司的《药品经营许可证》（证书编号：豫BA3771055）。　　特此公告。　　附件：南阳安一信大药房连锁有限公司《药品经营许可证》有关信息表　　2025年9月9日企业名称企业法人（负责人）质量负责人经营方式经营范围注册地址仓库地址证书编号南阳安一信大药房连锁有限公司杨德波(王天姿)田波零售连锁总部中药饮片,中成药,生化药品,抗生素制剂,化学药制剂,以上不含冷藏冷冻药品河南省南阳市宛城区溧河乡清河路路北16号河南省南阳市宛城区溧河乡清河路路北16号豫BA3771055

按照《中华人民共和国行政许可法》《医疗器械生产监督管理办法》等有关规定，根据企业申请，现注销际华三五三四制衣有限公司《医疗器械生产许可证》。特此通告附件:《医疗器械生产许可证》注销企业名单山西省药品监督管理局    2025年9月8日       序号                            企业名称           许可证编号     1       际华三五三四制衣有限公司    晋药监械生产许20200022号

近期，经太原市小店区、晋源区市场监管局查实，注册单位为山西香雪医药有限公司香雪大药房、太原市同智强国大药房有限公司等22名执业药师（具体名单附后）与实际工作单位不一致，不能保证在岗执业，不能履行执业药师法定职责。依据《执业药师注册管理办法》第三十四条规定，撤销该22人《执业药师注册证》。特此通告附件：拟撤销《执业药师注册证》人员名单山西省药品监督管理局     2025年9月9日 序号姓 名执业药师注册单位执业药师注册证号1刘树德山西香雪医药有限公司香雪大药房1422250102402李秋勤山西香雪医药有限公司香雪大药房1422240117643朱文华太原市春天大药房连锁有限公司晋阳街分店1412240116604王贾静山西复盛公大药房连锁有限公司太原郑村店1422240120395武建丽山西国邦大药房连锁有限公司北营新村店1412230110566宋丽花山西康尔福大药房有限责任公司龙城分公司1412240116417任录辉山西万佳康大药房有限公司马练营店1412240110758刘占滨太原市华聚堂万民药房有限公司1412210117639高 洁山西敬仁堂大药房连锁有限公司北格店14122001169410布丹芝山西敬仁堂大药房连锁有限公司郜村店14222101107711郝红丽太原市信望爱大药房有限公司14222301135112郑 巍太原市益民仁人和大药房（个人独资）14122401172613范晓霞太原市同智贺国大药房有限公司14122201125214刘小艳太原市禄祥老百姓大药房（个人独资）14122401188915袁黎明山西国邦大药房连锁有限公司西湖林语北门店14222301109716吕薛平太原聚鑫百姓药房有限公司14222401135517王存鱼山西省同德堂药业有限公司14122101003118杨晋霞山西海五汇星药房有限公司义井分公司14222401035319刘振华山西本康药房有限责任公司14222201127920刘 艳太原市同智强国大药房有限公司14222401283121潘娟娟太原辛德源大药房14222401005022张志萍太原市妙仁堂药业有限公司141220011791