各区医保局、各有关单位：为深入贯彻落实《国务院办公厅关于健全药品价格形成机制的若干意见》，进一步加强药品价格监测预警，丰富监测维度和处置方式，促进药品挂网价格确定规范合理。一、主要目标构建“纵向联动，横向比对”的药品价格监测体系，定期开展处置工作，推动不同渠道间药品价格公开、合理。全面落实全国药品挂网价格一览表（以下简称“一览表”），实现市医药采购平台的药品挂网价格（以下简称“挂网价格”）与一览表价格数据纵向联动。加强定点医疗机构、定点零售药店、网络售药平台、个人账户购药等渠道药品销售价格信息采集，形成与挂网价格的多渠道横向比对，联动处置。二、监测处置内容（一）加强全国药品挂网价格一览表应用对西药、中成药挂网价格进行严格审核把关，按要求定期上传国家平台，确保我市上传信息完整准确。加强一览表在药品挂网价格管理中的应用，定期将挂网价格与一览表价格进行监测比对，对挂网价格高于一览表价格的品种进行处置。（二）加强药品量价比较指数系统应用加强量价比较指数系统应用，依托量价比较指数系统，按季度发布我市定点零售药店指数值，发挥量价比较指数对定点零售药店销售价格的引导作用。定期向国家医保信息平台上传我市定点零售药店监测结果，在医保信息系统更新药品挂网价格信息，对定点零售药店销售价格众数与挂网价格存在差异的药品、定点零售药店进行处置。（三）加强定点医疗机构采购数据应用加强定点医疗机构在市医药采购平台实际采购价格的应用，定期对实际采购价格低于挂网价格的品种进行监测比对，做好实际采购价格的应用。定期对定点医疗机构“红黄标”预警药品采购情况进行监测，对超“红黄标”采购比例要求的定点医疗机构进行提醒、约谈、处置。（四）常态化开展线上线下比价利用网上药店信息透明、比价便利、竞争充分的特点，常态化开展线上线下比价，研判异常价格。探索通过对接电商平台的方式，获取药品基础信息、交易订单、交易价格等数据，定期开展数据监测比对，对网上药店销售价格与挂网价格存在差异的品种进行处置。（五）加强中药饮片、中药配方颗粒价格监测处置持续推进我市中药饮片、中药配方颗粒通过采购平台实现全量网上采购，逐步梳理中药饮片挂网产品质量标准，完善中药饮片挂网价格管理。依托中药配方颗粒“京津冀”价格协同机制，定期梳理中药配方颗粒价格并进行调整。（六）加强医院制剂价格监测处置推进定点医药机构医院制剂品种信息上传采购平台，推动医院制剂同品种（指名称及质量标准相同的制剂产品）不同剂型、规格产品价格保持在合理比价空间。（七）加强异常价格核查处置完善“津医保”比价程序，发挥群众对价格的监督作用，在比价程序中增设“一键投诉”功能，对“阴阳价格”等不合理定价行为，支持通过“一键投诉”进行反馈，对群众反映价格问题集中的品种、定点零售药店进行处置。对日常检查中发现的异常价格问题，穿透至生产企业，采取书面问询、成本调查、约谈提醒等措施督促企业规范价格行为。三、加强组织领导和协调联动（一）加强组织领导加强药品价格监测工作的组织领导，加强部门协调联动，共同研究推动监测体系建设、日常信息维护、数据交互等工作，做好与其他相关工作的衔接。（二）强化信息化支撑进一步完善信息系统，丰富药品价格采集渠道，持续将网络平台价格、个人账户购药价格等多渠道信息纳入平台，支持通过信息化手段完成价格比对。丰富完善市医药采购平台监测、统计、分析功能，推动与医保系统相关数据的交换应用。（三）加强协调联动医药服务处加强对药品价格监测体系的统筹协调，牵头做好监测体系建设工作，加强与市场监管、卫生健康等部门的协同，组织市医药采购中心、医保中心、结算中心及时按照我市医保药品信息维护流程做好医保系统信息更新。网信办按照监测体系建设需求，做好系统开发和日常维护管理工作。市医药采购中心细化工作流程，不断丰富完善处置原则，依托药品价格监测系统加强对药品挂网价格的调整完善。各区医保局、医保经办机构、医保监督所将药品价格纳入日常管理、监督检查中，对发现的问题线索及时反馈市医药采购中心，助力挂网价格规范调整，对涉嫌违法违规的行为及时移送相关部门。市医保局2026年9月4日

国家医保局组织编写的《国家医保基金智能监管知识库、规则库（2025年版）》已于近日出版发行，以帮助定点医药机构及其工作人员熟悉掌握医保基金监管规则，通过智能化方式主动合规、持续合规，实现监管关口前移。现按计划将“诊断与患者性别不符”规则有关“某些传染病和寄生虫病”等9章对应知识点明细面向社会公开。各省级医保部门要及时根据最新知识点明细及代码对省级医保信息平台智能监管子系统“两库”进行动态更新。定点医药机构可以将智能监管“两库”置于本机构智能提醒等信息化系统中，也可以对接医保部门智能监管系统事前提醒功能模块，对医保基金使用行为开展自动提醒和自查自纠，将不合规的行为消除在“萌芽”阶段，从源头上减少使用医保基金违法违规行为发生。各级医保部门和定点医药机构在使用“两库”规则和知识点过程中的意见建议，欢迎及时向我们反馈。联系人邮箱：jjjgs522@nhsa.gov.cn。附件：第二十一批“诊断与患者性别不符”规则对应部分知识点明细.pdf

2026年8月，上海市药品监督管理局共批准首次注册医疗器械产品32项（具体产品见附件）。特此通告。附件：2026年8月批准注册医疗器械产品目录上海市药品监督管理局2026年9月4日附件2026年8月批准注册医疗器械产品目录序号产品名称注册人名称注册证编号1镍钛合金消化道取石网篮上海埃尔顿医疗器械有限公司沪械注准202620202742丝素蛋白凝胶敷料上海锐捷荣创医疗科技有限公司沪械注准202621402753医用丝素蛋白复合凝胶上海锐捷荣创医疗科技有限公司沪械注准202621402764皮肤烟酸反应测试仪上海添音生物科技有限公司沪械注准202620702775自动腹膜透析机上海心光生物医药有限责任公司沪械注准202621002786一次性使用输尿管肾盂内窥镜导管上海安清医疗器械有限公司沪械注准202620602797内窥镜用外套管上海澳华内镜股份有限公司沪械注准202620602808内窥镜用气囊上海澳华内镜股份有限公司沪械注准202620202819双能X射线骨密度仪澳思托医疗器械（上海）有限公司沪械注准2026206028210腕关节康复训练系统上海卓道医疗科技有限公司沪械注准2026219028311踝关节康复训练系统上海卓道医疗科技有限公司沪械注准2026219028412多关节康复训练系统上海卓道医疗科技有限公司沪械注准2026219028513病人监护仪上海联影医疗科技股份有限公司沪械注准2026207028614医用图像处理工作站上海擎湃智能科技有限责任公司沪械注准2026206028715电动液压手术台上海派可斯医疗器械有限公司沪械注准2026215028916一次性穿刺活检针上海意嘉利尼医疗科技发展有限公司沪械注准2026214029017全自动微生物培养系统梅里埃（上海）生物制品有限公司沪械注准2026222029118口腔护理液上海高科生物工程有限公司沪械注准2026217029219医用气腹机上海电镜医疗科技有限公司沪械注准2026206029320中央监护系统软件上海光电医用电子仪器有限公司沪械注准2026221029421一次性使用管式切割穿刺活检针上海意嘉利尼医疗科技发展有限公司沪械注准2026214029522可调距颅内导管上海东湖机械厂沪械注准2026202029623脊柱矫形器上海致惠医疗科技有限公司沪械注准2026219029724一次性使用破皮导引针上海康德莱企业发展集团股份有限公司沪械注准2026214029825一次性使用输尿管导引鞘上海辛菖医疗器械有限公司沪械注准2026202029926封堵取石导管益佳达医疗科技（上海）有限公司沪械注准2026202030027磷酸化Tau 181蛋白（p-Tau 181）测定试剂盒（化学发光免疫分析法）上海透景生命科技股份有限公司沪械注准2026240030128β淀粉样蛋白1-42（Aβ1-42）测定试剂盒（化学发光免疫分析法）上海透景生命科技股份有限公司沪械注准2026240030229六种类固醇激素测定试剂盒（液相色谱-串联质谱法）上海脉示生物技术有限公司沪械注准2026240030330磷酸化Tau 217蛋白（p-Tau 217）测定试剂盒（化学发光免疫分析法）上海透景生命科技股份有限公司沪械注准2026240030431β淀粉样蛋白1-40（Aβ1-40）测定试剂盒（化学发光免疫分析法）上海透景生命科技股份有限公司沪械注准2026240030532脂溶性维生素测定试剂盒（液相色谱-串联质谱法）上海脉示生物技术有限公司沪械注准20262400306

Delivery Method:Electronic EmailReference #:CBER-26-728673Product:BiologicsRecipient:Stephen J. Fallon, Ph.D.1401 North East 26th StreetWilton Manors, FL 33305United States sfallon@latinosalud.orgIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERCBER-26-728673August 27, 2026Dear Dr. Fallon:This Warning Letter informs you of objectionable conditions observed during a U.S. Food and Drug Administration (FDA) inspection conducted at your clinical study site between June 2, 2025, and June 13, 2025. The FDA Investigators met with you during the inspection to review your conduct and oversight as a clinical investigator of the clinical study entitled, “A study to evaluate the performance, usability, and result interpretation of INSTI® HIV Self-Test when performed by observed intended users in the US” (Protocol CLS-003).FDA conducted this inspection under the Bioresearch Monitoring (BIMO) Program, which includes inspections designed to review the conduct of research involving investigational products and to help ensure that the rights, safety, and welfare of human subjects are being protected. At the conclusion of the inspection, a Form FDA 483, Inspectional Observations, was issued and discussed with you.We reviewed the Establishment Inspection Report (EIR), documents accompanying that report and the Form FDA 483 issued to you. Because you did not provide a response to the list of observations from your inspection, we were unable to evaluate your perspective on the findings, your explanations for the deficiencies, or your commitment to implementing further measures to prevent similar problems in the future, along with a clear timeline to achieve any planned implementation.Based on our review of the Establishment Inspection Report (EIR), documents accompanying that report, and the Form FDA 483, you violated regulations governing the proper conduct of clinical studies involving investigational products, including regulationspublished in Title 21 of the Code of Federal Regulations (CFR), part 812 [21 CFR 812] and 50 [21 CFR 50] (available at Code of Federal Regulations Title 21). The applicable provisions of the CFR are cited for each violation listed below. The violations include but are not limited to the following:1. You failed to properly obtain and document legally effective informed consent in accordance with the provisions of 21 CFR Part 50.27(a) and 21 CFR 812.100.You did not ensure that informed consents were signed and dated by the subject or the subject’s legally authorized representative at the time of consent, and you did not ensure a copy of the consent was given to the person signing the informed consent form (ICF).a. Of the 42 ICFs signed by subjects, 35 showed that the study subjects did not personally record the effective consent date. Rather, your study coordinator documented these dates on the ICFs for these study subjects. Additionally, one study subject's ICF lacked documentation of the date of consent.b. Your study coordinator (CRC) attested that when study subjects requested a copy of their signed ICF, the CRC instructed the enrolled study subjects to sign a new consent form for their records. Another CRC at your study site stated that he did not give subjects a copy of the signed ICF, nor did he ask if they would like to receive one.Due to these failures, we cannot verify that proper informed consent was performed from study subjects prior to their enrollment in the study. Additionally, we are not able to assess how many enrolled subjects did not receive a copy of their signed ICF as required by the provisions of the 21 CFR 50.27(a).During the FDA investigator's discussion of the aforementioned findings with you, you acknowledged the observations and confirmed your understanding of the identified deficiencies. You also stated that you did not believe a formal response to the FDA regarding these objectionable observations cited on FDA Form 483 was necessary. As of the date of this letter, we have not received your response to the observations cited on Form FDA 483 that are listed in Item #1a above.Additionally, we acknowledge that the following findings were not included in the Form FDA 483 you received.2. You revised and implemented an informed consent form without obtaining approval imposed by an IRB. [21 CFR 812.110(b)]You modified the language in the Informed Consent Form (ICF) after it was approved by the IRB in three ways with respect to compensation type, who qualified for compensation and when compensation for participation in the study will be received.1 Subject to exceptions not applicable here, informed consent documents must include all elements described in 21 CFR 50.25. Financial compensation for participating in clinical research should be presented to the IRB at the time of initial review.2 Subject to exceptions not applicable here, 21 CFR 50.27 requires that all elements must be approved by the IRB prior to use for subjects’ consent.3. You failed to ensure that the investigation was conducted in accordance with the signed agreement with the sponsor and the investigational plan. [21 CFR 812.100 and 812.110(b)].During the inspection, the FDA investigator noted that you did not ensure Study CLS-003 was conducted according to the signed investigator statement; specifically, you failed to provide adequate oversight and supervision of the study. Examples, include, but are not limited to, the following:a. Study Protocol CLS-003, Section 7 states that each enrolled subject “is provided with 1 [one] unopened INSTI HIV ST kit. Subject performs INSTI® HIV ST observed and without any intervention from the operator. Subject records their INSTI® HIV ST result on the Subject INSTI® HIV ST Result Form.” On the test result record form, the sponsor specifically instructs the following: “The study participant will complete this form for recording their own INSTI® HIV ST result.” However, the inspection revealed that Subjects Participant INSTI® HIV Self-Test Result Record Form was completed by your study site staff throughout the study. According to your CRCs, they recorded subjects’ interpretation on the Participant INSTI HIV Self-Test Result Record Form, when it was to be completed by the subject, per protocol.When the FDA investigator inquired as to why the subjects did not complete the record form themselves, neither CRC was able to provide an adequate answer. Both CRCs confirmed they asked the subject what their interpretation of the self-test result was prior to completing the Participant INSTI HIV Self-Test Result Record Form. You failed to recognize this discrepancy throughout the study.b. Protocol Section 13.1 states a list of investigator responsibilities. You signed bioLytical’s Investigator Agreement, certifying that the clinical study would be conducted according to the signed investigator statement, which required maintaining accurate and adequate study records throughout the study. You failed to conduct the study according to the signed Investigator Agreement in that initials documented in the study site’s Delegation of Authority (DOA) log did not match initials in study documents throughout the study, which made it difficult to determine whether or not the study was conducted by the trained, qualified and delegated personnel who are listed in your DOA Log.We emphasize that as a clinical investigator, it is your responsibility to ensure that your studies for the FDA-regulated products are conducted in accordance with the investigator agreement and the study protocol, in compliance with the FD&C Act and applicable FDA regulations, to protect the rights, safety, and welfare of subjects, and to ensure the integrity of the study data collected at your study site.4. You failed to maintain accurate, complete, and current records relating to your participation in Study CLS-003 to 21 CFR 812.140(a)(2) and 812.140(a)(3):a. Your study site failed to maintain the device shipping records, such as Packing List, Certificate of Analysis, Toxic Substance Control Act Certification, and Export Certificate for Medical Devices from the shipment of the investigational device (INSTI® HIV ST) and comparator device involved in Study CLS-003. The FDA investigator was not able to determine if the study devices were delivered to your clinical study site in good condition for use, the dates of shipment, or the device lot numbers. Although you have maintained IP Accountability Log and IP Dispensing Log for both the INSTI HIV ST and comparator test devices, these records are missing the device lot numbers. Due to these source records lacking the lot number used for each study subject, the FDA investigator was unable to verify and confirm the specific lot numbers of the INSTI® HIV ST and comparator test devices used at your study site and verify that products meet regulatory standards throughout the supply chain.b. Staff initials recorded on many of the source records pertinent to the study, such as Enrollment Questionnaire, Screen and Enrollment Log, Participant’s INSTI® HIV Self Test Result Record Form and Operator Results Form, do not match the staff initialsentered in your study site’s DOA Log. Therefore, it is unclear that you maintained accurate and complete records of the names of all persons who received, used, or disposed of each device.c. Your study site used White-out to change the original entry of some of the information collected for Study CLS-003. As such, it was impossible to determine what information was initially recorded for some study subject records, and the FDA investigator was not able to evaluate the author or date of those changes.This letter is not intended to be an all-inclusive list of deficiencies with your clinical investigation. It is your responsibility to ensure adherence to all requirements in the Federal Food, Drug and Cosmetic Act (FD&C Act) and all applicable regulations. You should address any deficiencies and ensure that any ongoing or future studies comply with FDA regulations.We further note during the inspection that you expressed your intention not to continue serving as a clinical investigator at Latinos Salud, Inc. to conduct clinical studies of FDA regulated products. Regardless of your decision to discontinue your participation in clinical trials of FDA regulated products, we advise that you provide us with a response to the above mentioned violations.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 or plan to take to correct the listed violations and prevent similar violations in the future. Include any documentation necessary to show that the matters have been appropriately addressed and mediated. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion.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. FDA has several references available at Clinical Trials and Human Subject Protection for more information on human subject protection and the conduct of clinical research.Your response should be sent via email to CBERBIMONotification@fda.hhs.gov and send a copy to OIIBIMODivision2Correspondence@fda.hhs.gov.If you have any questions regarding this letter, please contact the Division of Inspections and Surveillance, CBER at 240-402-8979.Sincerely,/S/Vincent Amatrudo, JDActing DirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Researchcc:Christine Smith, Division DirectorFDA OII BIMO Division 2OIIBIMODivision2Correspondence@fda.hhs.gov__________________________1 It is noted in the EIR that Dr. Fallon stated that he was unaware of the ICF changes, and he did not know who had made the changes.2 See “Payment and Reimbursement to Research Subjects Guidance for Institutional Review Boards and Clinical Investigators” dated January 2018; 21 CFR 50.20.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDReference #:320-26-121Product:DrugsOver-the-Counter DrugsRecipient:Mr. Hamed AlaghebandianPresidentHappy Farm Botanicals, Inc.3708 West StreetHyattsville, MD 20785United States (b)(4)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesSeptember 1, 2026WARNING LETTERReference number: 320-26-121To Mr. Hamed Alaghebandian:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of 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 or legal action without further notice including, without limitation, seizure and injunction.FDA InspectionViolations were observed and documented during an inspection of your drug manufacturing facility, Happy Farm Botanicals, Inc., FDA Establishment Identifier (FEI) 3011407349, at 3708 West Street, Hyattsville, from March 30 to April 2, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.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).We reviewed your April 22, 2026, response to our Form FDA 483 in detail.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm manufactures over-the-counter (OTC) drug products, including (b)(4). Your firm failed to perform identification testing on raw materials and components, including APIs, prior to use in your OTC drug products. For example, your raw material test records for (b)(4) API lot (b)(4) show that you only performed organoleptic testing and did not perform a specific identity test. According to your management, you manufactured (b)(4) finished drug batches using this lot from March 2025 through September 2025. Additionally, you did not adequately qualify your (b)(4) supplier as the requalification date had lapsed.In your response, you acknowledge your failure to perform appropriate testing for incoming drug components, including APIs. You commit to implementing corrective actions and preventive actions (CAPAs) that include establishing a specific, non-organoleptic test for (b)(4) and all other APIs using a qualified method, and revising the raw material procedure to require at least one specific identity test on all APIs prior to use in drug product manufacturing.Your response is inadequate. You do not address why you failed to follow existing procedures requiring specific identity testing for all APIs. Additionally, you did not provide a detailed procedure outlining how all drug components will be assessed against compendial requirements. Further, your response lacks a comprehensive review of your material system, including supplier evaluations, to ensure the quality of all materials are acceptable prior to use in drug product manufacturing.Without adequate testing, you do not have scientific evidence that components conform to appropriate specifications prior to use in the manufacture of your drug products.In response to this letter, provide:A comprehensive, independent review of your material system, including but not limited to:o Evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified;o An assessment of all materials to determine whether they are consistently of acceptable quality;o A review to ensure assigned expiration or retest dates are appropriate (supported by data);o Adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.Based on a thorough review, provide a summary of your systems CAPA to remediate the vendor qualification program and prevent use of unsuitable components, containers and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s Certificates of Analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the components and drug products you manufacture.2. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Your firm failed to establish an adequate stability program to demonstrate that the chemical and microbiological attributes of your drug products meet established specifications and that they remain acceptable throughout their labeled expiry period. For example, accelerated stability data provided for (b)(4) consisted of three batches tested for (b)(4) at (b)(4)°C with no record of controlled humidity conditions. Multiple timepoints within your accelerated stability study were reported as “Not Available” and you identified failing results at (b)(4) for viscosity, which you did not investigate. Furthermore, your ongoing long term stability studies identified a failing viscosity result at twelve months, which was not investigated.In your response, you acknowledge your failure to perform an appropriate stability study to support labeled expiration dates. You commit to opening a CAPA to conduct a risk assessment for the (b)(4) distributed batches and will determine the appropriate action for the product. Additionally, you will perform a new accelerated stability study with revised viscosity specifications, revise procedures to require real-time stability testing through the assigned expiry, and initiate a new real-time study on at least three validation batches.Your response is inadequate. You fail to provide stability protocols with scientific evidence demonstrating that the test methods used will be stability-indicating for your drug products.In response to this letter, provide a comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to, the following:Stability-indicating methodsStability studies for each drug product in its marketed container-closure system before distribution is permittedAn ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains validDetailed definition of the specific attributes to be tested at each station (timepoint), as part of a program that encompasses each quality attribute that may change over the product shelf-lifeAll procedures that describe these and other elements of your remediated stability program3. Your firm’s quality control 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).Your quality unit (QU) failed to perform adequate oversight for the manufacture and testing of your drug products. For example, your QU failed to:Validate manufacturing processes for OTC drug products (21 CFR 211.100(a))Validate cleaning operations for non-dedicated manufacturing equipment (21 CFR 211.67(b)(3))Investigate and implement appropriate CAPAs to address recurring gasket seal failures on manufacturing equipment (21 CFR 211.67(a))Establish appropriate content release specification limits for APIs in finished drug products (21 CFR 211.160(b))Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate procedures and practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsA detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.A timeline for performing appropriate process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced without performing any process validation studies.Process performance protocol(s), and written procedures for qualification of equipment and facilities.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:o Drugs with higher toxicitieso Drugs with higher drug potencieso Drugs of lower solubility in their cleaning solventso Drugs with characteristics that make them difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.Your action plan to address any product quality or patient safety risks for batches of (b)(4) in U.S. distribution, including potential customer notifications and recalls or market withdrawals.A list of chemical and microbial test methods and specifications used to analyze each batch of your drug product before making a batch disposition decision, and the associated written procedures.Repeat Observations at FacilityIn the previous inspection, ending March 15, 2024, FDA cited similar CGMP observations. Your response dated April 5, 2024, stated you would establish an SOP for process validation, create a process validation protocol for (b)(4), and execute the test protocol using robust testing and replicate batching by December 2024. Your 2024 response also stated you would create a protocol to validate the cleaning procedure for non-dedicated equipment, and execute the test protocol. However, FDA documented during the April 2026 inspection that you did not complete process validation for your OTC drug products nor did you complete cleaning validation studies for non-dedicated manufacturing equipment, even though you had committed to do so. FDA is concerned that your commitments to address documented CGMP violations are not being implemented. Repeated failures demonstrate that executive management oversight and control over the manufacture of your drugs is inadequate.Drug Production CeasedWe acknowledge your plan to cease production of (b)(4) drugs at this facility. In response to this letter, clarify whether you have manufactured any additional batches since the close of the FDA inspection or if you intend to resume manufacturing any drugs at this facility in the future.If you plan to resume any drug manufacturing operations, notify this office before doing so. If you resume CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 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 all CAPA, before you pursue resolution of your firm’s compliance status with FDA.In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.ConclusionYou are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. 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 re-inspect to verify that you have completed corrective actions to address any violations.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 3011407349 and ATTN: Christopher Leach in the subject line of the email.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.FDA posts warning letters on www.FDA.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

西平县柏国医药零售连锁有限公司：近日，我局组织对你公司进行了监督检查，发现你公司存在严重缺陷项1项、主要缺陷项3项，存在安全隐患，不符合《药品经营质量管理规范》要求。根据《中华人民共和国药品管理法》《药品检查管理办法（试行）》相关规定，我局决定对你公司采取暂停销售的风险控制措施。请你公司收到本通知后立即暂停销售并全面整改。整改完成并消除安全隐患后，经我局组织现场核查符合要求方可解除暂停销售的风险控制措施。2026年9月7日

按照《中华人民共和国行政许可法》第七十条、《药品经营和使用质量监督管理办法》第二十七条有关规定，现将自治区药品监督管理局依据企业申请，注销8家企业《药品经营许可证》情况予以通告。附件：《药品经营许可证》注销企业名单内蒙古自治区药品监督管理局2026年9月4日附件《药品经营许可证》注销企业名单序号企业名称许可证编号注销时间1内蒙古壹合供应链有限责任公司蒙AA4770001822026年05月27日2内蒙古信联医药有限责任公司蒙AA4750002182026年04月30日3兴安盟滋民堂医药连锁有限公司蒙 BA4820000722026年03月10日4赤峰卫民大药房医药有限公司蒙 BA4760000542026年02月10日5内蒙古乌兰察布集宁区炽热医药有限公司蒙AA4740000092026年02月10日6内蒙古国洋中药材有限责任公司蒙AA4780001732026年02月06日7内蒙古华药堂连锁有限责任公司蒙 BA4790001022026年01月12日8内蒙古康中福大药房连锁有限公司蒙 BA4780000452025年12月30日

为深入贯彻落实国家药监局关于医疗器械临床创新成果转化“春雨行动”工作部署，推动以临床价值为导向的医疗器械源头创新，近日，内蒙古自治区药品监督管理局党组成员、副局长张涛带队赴内蒙古医科大学第二附属医院，开展“春雨行动”工作推进活动。活动期间，工作组实地调研了该院在医疗器械临床创新、医工结合研究及成果转化等方面的进展。医院及科研团队具体介绍了在临床创新领域的探索实践、阶段性成果以及在研项目的推进情况，重点对“内蒙古自治区医疗器械临床研究成果转化平台”申报的8个产品的工作原理、结构组成、临床价值等进行了详细阐述。工作组现场解读了医疗器械创新相关政策，系统介绍了《内蒙古自治区医疗器械临床创新成果转化“春雨行动”实施方案》，并围绕产品界定、注册申报等具体事项进行指导，以专业审评力量赋能医工融合创新。工作组对医院临床诊疗与科研创新成果予以肯定，鼓励医院抢抓政策机遇，充分发挥临床一线优势，深入挖掘诊疗需求，积极培育申报创新成果。针对目前存在的问题将积极协调相关部门予以解决；对重点创新项目实行清单化、专班化服务，精准提供政策与技术支持，深化产学研融合，推动科创与产业创新协同发展。本次活动是自治区药监局落实“春雨行动”、深化医工融合的重要举措。下一步，自治区药监局将常态化开展政策宣讲和对接服务，聚焦临床需求，疏通创新转化堵点，全力推动医疗器械临床创新成果落地上市，护航群众生命健康。

为深入贯彻落实药品监管“四个最严”要求，扎实推进药品经营环节“清源”巩固提升行动和“净网雷霆”百日整治行动，切实防范化解药品网络销售安全风险，自治区药监局梳理出台药品网络销售“十严禁”禁令，全面细化监管标尺、压实监管责任、建立长效机制，持续净化药品网络销售市场环境。压实主体责任，深化自查自纠。坚持线上线下一体化监管原则，明确药品网络销售企业必须严格执行“四同”一体化标准，构建采购验收、储存养护、处方审核、物流配送、不良反应监测等全链条质量管理体系。组织辖区药品网络零售企业开展合规专项培训，督促企业对照“十严禁”禁令逐条排查短板弱项，建立问题清单、整改台账，实行闭环销号管理，全面规范经营行为。强化精准执法，严查违规行为。将“十严禁”落实情况纳入日常检查、专项整治、飞行检查和线上监测核心内容，建立线上监测、线下核查联动监管机制，加大明察暗访、随机抽查力度。实施分类精准监管，对存在安全隐患的企业责令限期整改、约谈负责人、下发风险告知书；对违法经营行为依法从严处罚、降级风险等级；对典型违规案例公开曝光，落实信用联合惩戒，强化监管震慑效能。健全长效机制，构建多元共治格局。全面开展政策宣贯解读，实现辖区药品网络销售企业政策宣讲全覆盖，督促企业熟知禁令要求、严守合规底线。坚持专项整治与常态治理相结合，常态化开展合规宣讲和警示教育，引导企业诚信守法经营。依托12315、12345等平台全面畅通投诉举报渠道，健全线索受理、核查、处置、反馈闭环机制，构建企业自律、监管执法、社会监督的多元共治体系，推动全区药品网络销售行业规范化、法治化长效发展。

通用电气医疗系统（中国）有限公司报告，由于近期发现部分中心工作站在系统重启前，标题栏中显示“允许列表中的数据被破坏”这一消息时，会出现系统重启后至少需要3分钟才能恢复患者监护的情况，可能会延迟识别临床重要事件，通用电气医疗系统（中国）有限公司对其生产的中心工作站主动召回。召回级别为二级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。