经梨树县市场监督管理局核查，执业药师单亚军、田亚华存在挂靠《执业药师注册证》行为，依据《执业药师注册管理办法》第六章第三十四条规定，撤销执业药师单亚军、田亚华的《执业药师注册证》，三年内不予注册。具体信息如下：序号姓名身份证号执业药师注册证编号挂靠执业单位撤（注）销时间1单亚军220***********3118221225031079梨树县信康大药房连锁有限公司文礼分店2026年3月24日主动注销2田亚华220***********7669222225030342梨树县汇丰大药房连锁有限公司吉新分店2026年3月27日撤销特此公告。 吉林省药品监督管理局

安徽省药品监督管理局第四分局化妆品生产监督检查信息通告（2026年1期）

因药品经营许可证被吊销，依据《中华人民共和国行政许可法》第七十条第四款、《药品经营和使用质量监督管理办法》第二十七条第三款规定，决定注销重庆乐源医药有限公司《药品经营许可证》。现将注销情况予以公告。　　附件：注销的许可证内容                               　　　　　　　　　　　　　　　　　　　　　　　　　　重庆市药品监督管理局                                 　　　　　　　　　　　　　　　　　　　　　　　　　 2026年3月26日附件注销的许可证内容序号企业名称许可证名称许可证编号1重庆乐源医药有限公司药品经营许可证渝AA0231403

     近日，内蒙古自治区药监局全面启动2026年全区药品抽检工作，强化上市后药品质量安全监管，切实守护群众用药安全。本次抽检工作坚持开门纳谏，在品种遴选阶段，面向自治区卫生健康委、医保局以及基层药品监管机构和社会公众公开征集2026年药品抽检品种和中药材质量监测品种，广泛吸纳各方意见建议，确保抽检品种覆盖监管重点，符合自治区实际。针对群众高度关注的集采中选药品质量，自治区药监局明确对全区在产的国家及省级集采中选药品实施全覆盖抽检，确保群众关切的集采中选药品质量安全可控。本年度重点抽检历年国家及各省（区、市）通告的不符合规定中药饮片，以及临床用量大、使用频率高的基础中成药和化学药；同时，针对不良反应报告集中、医疗机构反馈质量问题突出的品种设立专项抽检，精准排查质量隐患，提升抽检的靶向性和实效性。随着线上购药日益普遍，网售药品质量安全成为监管重点。本年度抽检明确加大网售药品抽检力度，抽检批次数较上年度翻倍，通过强化网络抽检，规范网络药品经营秩序，切实守护群众线上购药安全。目前，2026年自治区药品抽检计划已经印发。计划对现场抽样、网络抽样以及各盟市本级药品抽检工作等各个环节提出了具体要求，确保抽检工作规范、高效、有序推进。下一步，自治区药监局将强化统筹协调，加强对各盟市抽检工作的督促指导，有序推进抽检任务落实。同时，及时分析研判药品质量状况，依法发布抽检结果，引导公众安全合理用药，持续筑牢药品质量安全防线。

序号1企业名称阜新逸康园医药有限公司企业类型药品批发企业检查时间2026年3月11日-2026年3月13日所在地市阜新市检查依据《药品管理法》《药品经营质量管理规范》等法律、法规。检查事项药品经营检查检查方式常规检查检查内容执行GSP情况存在问题在人员与培训方面存在2026年度培训内容不完整的问题。处理措施立即整改整改情况已按要求完成整改序号2企业名称阜新市鹏程医药连锁有限公司企业类型药品零售连锁总部检查时间2026年3月25日-2026年3月26日所在地市阜新市检查依据《药品管理法》《药品经营质量管理规范》等法律、法规。检查事项药品经营检查检查方式常规检查检查内容执行GSP情况存在问题在质量管理体系文件方面存在未对相关制度进行修订问题。处理措施立即整改整改情况已按要求完成整改

贵阳星启医疗器械有限公司报告，由于企业未经许可变更生产地址原因，贵阳星启医疗器械有限公司对其生产的定制式固定义齿（注册证号： 黔械注准20252170073）主动召回。召回级别为三级。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》。附件：贵阳星启医疗器械有限公司产品召回报告.pdf贵州省药品监督管理局2026年3月31日

经查，代言人生物医药（广西）有限公司申报“医用加热雾化器”医疗器械注册时存在提供虚假资料行为，依据《医疗器械监督管理条例》第八十三条的规定，决定撤销代言人生物医药（广西）有限公司医用加热雾化器（注册证编号：桂械注准20232080147）注册证。特此公告。 广西壮族自治区药品监督管理局 2026年3月30日

　　国家药监局组织对德国卡尔史托斯公司（英文名称：KARL STORZ SE & Co.KG）开展远程检查，检查品种为高频手术设备（英文名称：High-frequency Surgery System；注册证号：国械注进20203010343）。检查发现德国卡尔史托斯公司质量管理体系在产品软件版本控制、不良事件分析与处置、管理者代表履职等方面存在缺陷，产品存在质量安全隐患，综合评定结论为不符合我国《医疗器械生产质量管理规范》要求。　　为保障公众用械安全，根据《医疗器械监督管理条例》和《医疗器械生产监督管理办法》有关规定，国家药监局决定自即日起，对德国卡尔史托斯公司高频手术设备，暂停进口、经营和使用。　　特此公告。　　　　国家药监局2026年3月30日

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-26-53Product:DrugsRecipient:Ms. Lauren SzarzynskiOwnerMicrobiological Testing & Consulting, LLC5661 W. 120th StreetAlsip,IL60803United Stateslauren@mtcresearch.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-53March 16, 2026Dear Ms. Szarzynski:The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Microbiological Testing & Consulting, LLC, FEI 3003875820, at 5661 W. 120th Street, Alsip, from September 8 to 16, 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, the drug products you tested 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 September 30, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. 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 211.160(b) and 21 CFR 211.165(b)).Your firm is a contract testing laboratory that conducts testing of various application and nonapplication drug products for your customers. You failed to conduct appropriate testing to ensure that the results your firm provided to customers were accurate and scientifically sound.Lack of Adequate DocumentationYour firm lacks significant CGMP documentation for your microbiological testing. For example, you routinely failed to document specific attributes of each test such as:equipment numbersample sizemedia batch numbersample dilutionsincubation temperaturesname/signature of performing analystAccording to your personnel, your firm also lacked adequate equipment logs to track usage and maintenance.Your response is inadequate. You commit to performing a comprehensive review of your testing operations and records. Based on the outcome of the review, your firm plans to update the affected data and test forms. You did not provide specific details on the records, equipment, and data that will be evaluated, nor did you commit to conducting a full retrospective review of test results provided to your customers.Additionally, you indicate that going forward you will meet standards for laboratory studies. Please note that appropriate regulatory requirements for laboratories conducting testing for drug product manufacturers are 21 CFR parts 210 and 211 and Section 501(a)(2)(B) of the FD&C Act.Laboratory investigations cannot be performed when systems, procedures, and documentation are deficient.Complete and accurate records are necessary to ensure that test methods are consistently followed and reproducible. Additionally, complete test records are necessary to reliably conduct record reviews and adequately investigate deviations and drug product failures.Lack of Appropriate Media QualificationYou lack adequate controls to ensure the reliability of your microbiological testing results. For example, the media used to test your customers drug products was inadequately qualified. You lacked screening for inhibitory properties of your incoming lots of(b)(4).In your response, you commit to reviewing your tests and methods to identify gaps and implement the appropriate remediation.Your response is inadequate because you did not commit to pausing testing until assessments are complete, nor did you implement any interim corrective actions. Furthermore, your firm did not provide a plan to re-assess results that have been communicated to customers.In response to this letter, provide:A comprehensive independent assessment of your laboratory practices, procedures, methods, test results, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A retrospective risk assessment of gaps found in your growth media qualification and suitability testing practices over the past three years. Describe how these gaps will be remediated to ensure reliable microbial enumeration and appropriate identification of objectionable microorganisms.A complete assessment of documentation systems used throughout your laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.2. 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 firm lacks appropriate systems and procedures for quality oversight of laboratory testing, documentation, and investigations.As noted in the prior charge, your quality unit did not have adequate oversight of documentation, media qualification, and other critical microbiology laboratory programs. In addition, you lacked adequate systems for investigations and ensuring analyst competencies.Furthermore, your management stated that in the past two years your firm conducted only one product out-of-specification (OOS) investigation and one water out-of-limit (OOL) for total aerobic microbial count (TAMC) investigation. These two investigations were the only ones available for our investigator to review. However, records collected during an FDA inspection of one of your customers(b)(4), indicated that your firm reported several OOL for TAMC and objectionable microorganism results within the past two years. It appears that your firm did not make all requested OOS/OOL test data available during the inspection.In your response, you commit to implement a multiphase OOS investigation methodology. Your response is inadequate. You did not commit to assessing previous OOS results to ensure the investigations were adequate.Be reminded that it is your responsibility to ensure all data and information provided are accurate, complete, and readily available for inspection. As a contract laboratory, you must comply with the CGMP regulations that apply to operations you perform, including, but not limited to, those that address the operations of your quality control unit, laboratory, investigation system, and documentation system.Training ProgramYour training program is inadequate. CGMP training is not regularly performed at your firm as required by your established procedure. During the inspection, you could not provide records of CGMP training.In your response, you state a consultant will assess your training procedure for general CGMP requirements and a suitable CGMP training program shall be developed.Your response is inadequate. You do not provide any immediate steps to address the training program to ensure all employees are adequately trained to complete CGMP activities. Nor do you commit to stop testing until employees can receive appropriate CGMP training.In response to this letter, provide:A retrospective, independent review of all invalidated OOL/OOS (including raw material, in-process, and release/stability testing) results for the last three years from the initial date of inspection and a report summarizing the findings of the analysis, including the following for each OOL/OOS:o Provide a list of all OOS and OOL results that were not investigated and your corresponding corrective actions including a reassessment of all instances to determine any additional action needed related to nonconforming results.o For each OOL/OOS include your CAPA and how you will ensure all OOS and OOL results will be investigated and communicated in a timely manner to your customer(s) on the certificate of analysis for appropriate follow up.o Determine whether the scientific justification and evidence relating to the invalidated OOL/OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o An explanation for the discrepancy in the number of OOL and objectionable microorganism investigations that you provided to our investigator compared with the number that you provided to your customer,(b)(4).A comprehensive review and remediation plan for your OOL/OOS result investigation systems. The CAPA should include but not be limited to addressing the following:o Quality unit oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of causes of laboratory variationo Adequate scoping of each investigation and its CAPAo Assurance that data, findings, and supporting documentation relating to any OOS/OOL result are promptly conveyed to customerso Revised OOL/OOS investigation procedures with these and other remediationsA description of how top management supports quality assurance and reliable test operations including, but not limited to, timely provision of resources to proactively address emerging quality issues and to assure a continuing state of control.Documentation of training for all relevant personnel on revised policies, procedures, and other associated items.Data Integrity RemediationYour quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you test. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.Responsibilities of Contract Testing LabFDA considers contractors as extensions of the manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your customers. It is essential that you understand your responsibility to operate in full compliance with CGMP, and that you inform all your customers of any OOS results or significant problems encountered during the testing of these drugs.CGMP Consultant RecommendedBased 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.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.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also 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.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days1. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3003875820 and ATTN: Marva Taylor.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research______________1Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.