Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Jian XuPresidentBMC Medical Co., Ltd.No. 16 Lize RoadRoom 10, 17F Building 4, Huiya PlazaFengtai Qu Beijing Shi, 100073China(b)(6)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 725759May 20, 2026Dear Mr. Xu:During an inspection of 3B Medical, Inc. (d.b.a. React Health, Inc.) located at 5475 Rings Road, Dublin, OH 43017 from December 1, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer and 510(k) owner of various ventilator devices that are imported to the United States by 3B Medical, Inc. This includes Auto-Adjusting Positive Airway Pressure (Auto-CPAP or APAP) ventilator devices, intended for the treatment of obstructive sleep apnea in adults, under the brand name of G3X APAP (G4600). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.Unapproved Device ViolationsOur inspection revealed that your G3X APAP devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with significant changes or modifications without submitting a new premarket notification to FDA, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Your firm has made significant changes or modifications to the design of the Luna® CPAP and Auto CPAP System which was granted clearance on September 8, 2016 under 510(k) number K153387. The inspection at 3B Medical, Inc. established that you are the design change authority and 510(k) owner of the device. For example, FDA has reviewed your firm’s nP3_Product System Verification Report_G3-2.11.01 and Design change evaluation report, Project code: nP3 for the Luna G3 APAP, Model LG3600, approved on March 12, 2025, which revealed that the firmware/software was updated with additional recognition features, i.e., (1) Flow Limitation, (2) Respiratory Effort-Related Arousals (RERA), and (3) Periodic breathing, to distinguish between central hypopnea and obstructive hypopnea events.Furthermore, the sound abatement system of the cleared Luna APAP devices was modified to ‘(b)(4)’ or ‘(b)(4)’ and a new (b)(4) was added to the cleared Luna APAP device to match the sound reduction as a result of the material change. Additionally, the Printed Circuit Board Assembly (PCBA) includes a new (b)(4) chip compatible with the new algorithm and new data structure master control software. These design modifications to the cleared Luna APAP appear to have given rise to a new model branded as G3X APAP. These changes could significantly affect safety or effectiveness because they are significant changes in the design and materials of these devices. The firmware update introduced new detection algorithms capable of distinguishing between central and obstructive hypopnea events, which affects the accuracy of event classification and the data available to clinicians for evaluating therapy effectiveness and informing future therapy adjustments. The removal of (b)(4) represents a material change to the gas pathway that raises biocompatibility concerns, and when combined with the addition of a new (b)(4), these changes could affect the overall pressure and flow profile of the device, thereby impacting therapy delivery. The addition of a new (b)(4) PCBA chip and updated master control software introduces potential implications for electrical safety and overall device performance. Collectively, these changes represent significant modifications in device design, materials, and software that could significantly affect the safety and effectiveness of the device.FDA’s regulations at 21 CFR 807.81(a)(3)(i) provide that submission of a 510(k) is required for “a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.” Thus, the G3X APAP is misbranded under 502(o) because of your failure to submit the required premarket notification for the modifications. FDA requests that your firm cease any activities that result in the misbranding or adulteration of your devices.For further explanation on the need for a new premarket notification, or "510(k)," for changes to the intended use or design affecting safety and effectiveness, consult the guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device — Guidance for Industry and Food and Drug Administration Staff (fda.gov)." The “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff,” is also recommended for obtaining FDA feedback on the 510(k) submission for the G3 X APAP devices.Correction and Removals ViolationsOur inspection also revealed that your firm’s Luna G3 APAP devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals.Significant violations include, but are not limited to, the following:1. Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: your Luna G3 APAP devices with firmware G3-2.00.76 could cause the Luna G3 APAP device to unexpectedly shut down during use, which causes loss of therapy for patients with obstructive sleep apnea. You communicated with 3B (React Health) in (b)(4) to (b)(4). The action of updating the firmware to G3-2.00.77 is a medical device correction or removal initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA.Your firm has not submitted a Report of Correction or Removal to FDA for the firmware update to G3-2.00.77 as of May 19, 2026.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. The inspection of 3B Medical on December 1, 2025 to December 10, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, should any corrective actions you propose or implement relate to device current good manufacturing practice (CGMP) requirements, they must be made pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Gina Brackett, Establishment Assessment Team 1 Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 725759” when replying. If you have any questions about the contents of this letter, please contact: Sargum Morgan, Compliance Officer at sargum.morgan@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Barbara A. MarsdenDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC:(b)(4), (b)(6)

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Gale H. Thorne Jr.Chief Executive OfficerAseptiKits, LLC101 N. 700 WNorth Salt Lake, UT 84054United States(b)(6)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS 728184June 4, 2026Dear Mr. Thorne:During an inspection of your firm located in North Salt Lake, UT from November 11, 2025, through December 3, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets the PALA YourTears models (8,12,14), ALAdrop, SyrilKit, and VitrALA devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Unapproved Device Violation(s)Our inspection revealed that the PALA YourTears models (8,12,14), ALAdrop, SyrilKit, and VitrALA devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have, for any of these products, an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).You stated in your response that these devices fall under product code NEP and are exempt from premarket notification under 21 CFR 880.5440(b).Under 21 CFR 880.5440(a), an intravascular administration set is a device used to administer fluids from a container to a patient’s vascular system through a needle or catheter inserted into a vein. While under 21 CFR 880.5440(b) some pharmacy compounding systems are exempt from the requirement of premarket notification, in accordance with FDA special controls guidance Pharmacy Compounding Systems - Final Class II Special Controls Guidance Document for Industry and FDA, such exemption “does not encompass the ancillary devices that make up the delivery and container system,” including “fluid transfer sets, metering chambers, I.V. bags, connectors, or other components that provide a fluid contact surface.” (This guidance document is the special control for pharmacy compounding systems within the intravascular administration set classification. 21 CFR 880.5440(b).) Such ancillary devices are classified separately from pharmacy compounding systems.FDA identifies a pharmacy compounding system as an “apparatus, often controlled by software, that is intended to deliver a specified quantity of one or more injections through a designated fluid pathway to achieve in a receiving vessel an injection having a specified concentration or proportion of ingredients different from the initial injections.” Pharmacy Compounding Systems - Final Class II Special Controls Guidance Document for Industry and FDA. Per your marketing website (www.aseptikits.com), the PALA YourTears models (8,12,14) is a closed system bag with filters and syringes intended for sterile preparation of serum. The ALAdrop is a closed system bag with syringe and filter intended for sterile eye drop preparation. The SyrilKit is a kit of 20 syringes with filters intended for sterile solution preparation. The VitrALA is a closed system bag with filters and syringes that is intended to prime and measure drug products. Therefore, the subject devices are syringes, filters and closed system transfer devices (bag). These devices fall under various product codes such as FMF (for syringe) and ONB (for closed system transfer devices).These product codes are for class II, non-exempt devices. The products, which contain syringes and containers for the drug, are not pharmacy compounding systems. Accordingly, the subject products are not exempt from premarket notification under 21 CFR § 880.5440(b).In addition, we have reviewed your website, Home | Aseptikits. The website includes references to convenience kits and states “Included class II medical devices are 510(k) approved and assembled into patented convenience kits for medical use.” As noted above, however, the subject products, which are marketed on your website, have not been cleared or approved by FDA for marketing in accordance with FDA’s regulations. Nor is it true that, as your website says, “Kits meet FDA requirements for Convenient[sic] Kits.” Your website includes a statement under “Key Differentiators” that your products “Meets or exceeds FDA regulations.” Because the subject devices lack required authorization, these representations are false and misleading and a device is misbranded within the meaning of section 502(a) of the Act, 21 U.S.C. § 352(a), if its labeling is false or misleading in any particular.For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Our office requests that you immediately cease any activities that result in the misbranding or adulteration of your devices, such as the commercial distribution of your devices for the uses discussed above.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Jeff Wooley, Acting Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 728184” when replying. If you have any questions about the contents of this letter, please contact: Jeff Wooley at jeffrey.wooley@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility or associated with your firm’s devices. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/CDR Cesar A. Perez, PhD, USPHSActing Deputy DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDReference #:320-26-96Product:Drugs;Over-the-Counter DrugsRecipient:Mr. Allen LuYangzhou Hongshengding Chemical Co., Ltd.No. 8, Sitong Road, Hangji Industrial ParkGuangling Qu Yangzhou Shi Jiangsu Sheng, 225111China395745820@qq.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 15, 2026WARNING LETTERReference Number: 320-26-96Dear Mr. Lu:This Warning Letter advises you of significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations for Yangzhou Hongshengding Chemical Co., Ltd. (hereafter YHC), FEI 3013166766, located at No. 8, Sitong Road, Hangji Industrial Park, Guangling District, Yangzhou.Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products.A review of import records showed multiple shipments of OTC drug products into the U.S. market, which declared YHC as the drug manufacturer. The FDA sent several requests for records and other information, pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact email address provided in your registration file. These requests went unanswered by your firm.It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record, as required by section 704(a). Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs listed as having been manufactured at your facility.Refusal to Provide RecordsAccording to FDA records, your firm initially registered as a drug manufacturer in October 2016 and then had your registration switched to out-of-business in July 2019. FDA staff contacted your firm in July 2023 and were informed that your firm was still in business. Personnel from your firm stated at that time that you had not manufactured or shipped any drug products intended for the U.S. market in several years and did not have any future plans to do so.In June 2025 your firm re-registered with FDA as a drug manufacturer, and you resumed drug shipments to the U.S. market the following month. On January 20, 2026, the FDA sent an initial electronic request for records and other information, pursuant to section 704(a)(4) to the contact email address provided in your registration file and your U.S. Agent. This request went unanswered.A second request to your firm and to your U.S. Agent was sent via email on February 4, 2026. Your U.S. Agent responded on February 9, 2026, requesting an extension until March 5, 2026. FDA responded that the deadline for providing records would be extended only until February 17, 2026. FDA received no response to this communication.FDA sent a follow-up written request for such records and other information on March 2, 2026. The shipper confirmed delivery of the written request to your firm1, but you failed to respond to these attempted communications or to provide the requested records or information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records being sought.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations at your facility.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-79 on June 3, 2026.Until FDA can confirm your compliance with Current Good Manufacturing Practice and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Yangzhou Hongshengding Chemical Co., Ltd., located at No. 8, Sitong Road, Hangji Industrial Park, Guangling District, Yangzhou, coming into the U.S. market that appear to be adulterated or misbranded are subject to being detained or refused admission, pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).After you receive this letter, please respond to this office in writing within 15 working days. In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices, and/or you may submit a request to schedule an FDA inspection.Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3013166766 and ATTN: Ernest Bizjak in the subject line.Please note that 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

辽宁省药品监督管理局行政检查结果公示 序号：1企业名称沈阳丽人医疗科技有限公司企业类型医疗器械生产检查时间2026年5月18日-2026年5月19日所在地市沈阳市检查依据《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械生产质量管理规范》等法规规章和规范性文件检查事项医疗器械生产企业检查检查方式常规检查检查内容贯彻落实《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械生产质量管理规范》情况存在问题在设备方面，存在个别规定不详细的问题。 处理措施限期整改整改情况已按要求完成整改序号：2企业名称沈阳藤王宫药业有限公司企业类型医疗器械生产检查时间2026年5月27日-2026年5月30日所在地市沈阳市检查依据《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械生产质量管理规范》等法规规章和规范性文件检查事项医疗器械生产企业检查检查方式常规检查检查内容贯彻落实《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械生产质量管理规范》情况存在问题在厂房与设施方面，存在成品库个别区域划分不明确的问题；在文件管理方面，存在个别文件内容不准确的问题。处理措施限期整改整改情况已按要求完成整改序号:3企业名称辽宁医用制品发展有限公司企业类型医疗器械生产检查时间2026年5月22日-2026年5月23日所在地市沈阳市检查依据《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械生产质量管理规范》等法规规章和规范性文件检查事项医疗器械生产企业检查检查方式常规检查检查内容贯彻落实《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械生产质量管理规范》情况存在问题在厂房与设施方面，存在洁净室个别实施管理不到位的问题；在设备方面，存在个别设备检定不及时的问题。处理措施限期整改整改情况已按要求完成整改

行政相对人名称：吉林省雨田药品销售有限公司法定代表人：张志国统一社会信用代码：91220282MAE4FA1CXQ行政处罚决定文书号：桦市市监处罚﹝2026﹞98号处罚类别：罚款;没收违法所得处罚决定日期：2026-06-18处罚内容：当事人2026年3月13日,从河北汉枫药业有限公司购进百合1袋(批号012260301、0.5kg/袋),购进价格62元/袋,售价80元/袋;2026年3月31日,从成都市天晟中药材饮片有限责任公司购进龙眼肉1袋(批号260201、1kg/袋),购进价格39.88元/袋,售价80元/袋;2026年3月13日,从河北祥芝药业有限公司购进黄精3袋(批号C242260101、1kg/袋),购进价格54.90元/袋,售价75元/袋-80元/袋;2026年4月13日,从安徽林生堂药业有限公司购进五味子2袋(批号251101、1kg/袋),购进价格34.6元/袋,售价75元/袋;2026年3月7日,从渭源嘉佑药业有限公司购进黄芪6袋(批号26012801、1kg/袋),购进价格18元/袋,售价50元/袋;2026年1月3日,从湖北民泰药业有限责任公司购进黄芪5袋(批号250701、1kg/袋),购进价格16.5元/袋,售价50元/袋。当事人可提供上述22袋中药饮片的供货商资质及进货票据。当事人于2026年3月12销售1袋麦冬120元、2026年3月13日销售1袋百合80元、2026年2月6日销售3袋黄精230元,共计430元。依据《药品经营和使用质量监督管理办法》第六十八条第一款:“药品经营企业未经批准变更许可事项或者药品经营许可证超过有效期继续开展药品经营活动的,药品监督管理部门按照《药品管理法》第一百一十五条的规定给予处罚。”、《药品管理法》第一百一十五条“未取得药品生产许可证、药品经营许可证或者医疗机构制剂许可证生产、销售药品的,责令关闭,没收违法生产、销售的药品和违法所得,并处违法生产、销售的药品(包括已售出和未售出的药品,下同)货值金额十五倍以上三十倍以下的罚款;货值金额不足十万元的,按十万元计算。”之规定,办案机构建议责令当事人改正违法行为并对其处罚如下:“1.没收龙眼肉1袋、五味子2袋、金银花1袋、党参2袋、黄芪11袋,共计中药饮片17袋。2.没收违法所得115.3元。3.罚款10000元。4.责令关闭15天。”罚款金额（万元）：1没收违法所得、没收非法财物的金额（万元）：0.16453暂扣或吊销证照名称及编号：— —违法行为类型：未取得药品生产许可证、药品经营许可证或者医疗机构制剂许可证生产、销售药品的行为违法事实：经查,当事人2026年3月13日,从河北汉枫药业有限公司购进百合1袋(批号012260301、0.5kg/袋),购进价格62元/袋,售价80元/袋;2026年3月31日,从成都市天晟中药材饮片有限责任公司购进龙眼肉1袋(批号260201、1kg/袋),购进价格39.88元/袋,售价80元/袋;2026年3月13日,从河北祥芝药业有限公司购进黄精3袋(批号C242260101、1kg/袋),购进价格54.90元/袋,售价75元/袋-80元/袋;2026年4月13日,从安徽林生堂药业有限公司购进五味子2袋(批号251101、1kg/袋),购进价格34.6元/袋,售价75元/袋;2026年3月27日,从安徽省麒源药业科技有限公司购进金银花1袋(批号2512001、1kg/袋),购进价格99元/袋,售价140元/袋;2026年3月12日,从成都市天晟中药材饮片有限责任公司购进麦冬1袋(批号250703、1kg/袋),购进价格88元/袋,售价120元/袋;2026年3月1日,从湖南协仁药业有限公司购进党参2袋(批号2509002、1kg/袋),购进价格44.99元/袋,售价90元/袋;2026年3月7日,从渭源嘉佑药业有限公司购进黄芪6袋(批号26012801、1kg/袋),购进价格18元/袋,售价50元/袋;2026年1月3日,从湖北民泰药业有限责任公司购进黄芪5袋(批号250701、1kg/袋),购进价格16.5元/袋,售价50元/袋。当事人可提供上述22袋中药饮片的供货商资质及进货票据。当事人于2026年3月12销售1袋麦冬120元、2026年3月13日销售1袋百合80元、2026年2月6日销售3袋黄精230元,共计430元。处罚依据：第一百一十五条:未取得药品生产许可证、药品经营许可证或者医疗机构制剂许可证生产、销售药品的,责令关闭,没收违法生产、销售的药品和违法所得,并处违法生产、销售的药品(包括已售出和未售出的药品,下同)货值金额十五倍以上三十倍以下的罚款;货值金额不足十万元的,按十万元计算。处罚机关：桦甸市市场监督管理局处罚机关统一社会信用代码：11220282316686862G数据来源单位：桦甸市市场监督管理局数据来源单位统一社会信用代码：11220282316686862G

成都禾创西区医药科技有限公司自愿申请我局对其接受委托储存药品的条件进行检查。经我局组织现场检查，该公司受检仓库符合四川省《药品第三方现代物流指导意见》要求，现予以公示。受检仓库地址：成都高新区百草路969号1号楼1-3层、4层A区、6-8层、2号楼。  四川省药品监督管理局2026年6月30日

一、铜仁市思南县百信麒龙药房串换销售化妆品案思南县医疗保障局对百信麒龙药房进行现场检查，发现该药店存在将妆字号化妆品天然时光烟酰胺燕窝多肽串换为医保目录内品类，并使用参保人医保个人账户结算的行为。思南县医疗保障局根据《零售药店医疗保障定点管理暂行办法》（国家医疗保障局令第3号）有关规定，自2026年4月13日起解除该药店医保服务协议。二、安顺市普定县安炽大药房串换销售化妆品案飞行检查组对普定县安炽大药房进行现场检查，发现该药店存在将妆字号化妆品索雅香体露串换为医保目录内品类，并使用参保人医保个人账户结算的行为。普定县医疗保障局根据《零售药店医疗保障定点管理暂行办法》（国家医疗保障局令第3号）有关规定，自2026年5月19日起解除该药店医保服务协议。三、毕节市七星关区宝芝林大药房串换销售保健食品案七星关区医疗保障局对宝芝林大药房进行现场检查，发现该药店存在将国食注健食品汤臣倍健蛋白粉串换为医保目录内品类，并使用参保人医保个人账户结算的行为。七星关区医疗保障局根据《零售药店医疗保障定点管理暂行办法》（国家医疗保障局令第3号）有关规定，自2026年5月29日起解除该药店医保服务协议。

主体名称桐乡市大麻颐寿堂医药西桥路连锁店处罚决定书文号桐市监处罚﹝2026﹞1202号处罚类别罚款;没收违法所得处罚决定时间2026-06-29处罚内容当事人未按规定从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的行为违反了《中华人民共和国药品管理法》第五十五条第一款的规定,根据《中华人民共和国药品管理法》第一百二十九条的规定,决定对当事人违法行为作如下处理:1.没收违法所得29.5元;2.处罚款3000元。罚款金额（万元）0.300000没收违法所得0.002950暂扣或吊销证照名称及编号-违法行为类型桐乡市大麻颐寿堂医药西桥路连锁店从非法渠道购进药品案处罚依据《中华人民共和国药品管理法》第一百二十九条违反本法规定,药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的,责令改正,没收违法购进的药品和违法所得,并处违法购进药品货值金额二倍以上十倍以下的罚款;情节严重的,并处货值金额十倍以上三十倍以下的罚款,吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构执业许可证;货值金额不足五万元的,按五万元计算;违法事实主要违法事实:当事人未按规定从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品。行政处罚种类、依据、内容:当事人未按规定从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的行为违反了《中华人民共和国药品管理法》第五十五条第一款的规定,根据《中华人民共和国药品管理法》第一百二十九条的规定,决定对当事人违法行为作如下处理:1.没收违法所得29.5元;2.处罚款3000元。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关桐乡市市场监督管理局处罚机关统一社会信用代码11330483002559924T数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420

主体名称东阳市逸龙化妆品有限公司处罚决定书文号东市监处罚﹝2026﹞786号处罚类别警告;罚款;没收违法所得处罚决定时间2026-06-29处罚内容当事人生产经营未备案化妆品的行为,违反了《化妆品监督管理条例》第十七条之规定。当事人未执行产品进货查验记录制度的行为,违反了《化妆品监督管理条例》第三十一条之规定。当事人伪造生产许可证标志的行为,违反了《中华人民共和国工业产品生产许可证管理条例》第三十五条之规定。依据《中华人民共和国行政处罚法》第二十八条第一款、第二十九条、《化妆品监督管理条例》第六十一条第一款第一项和《中华人民共和国工业产品生产许可证管理条例》第五十一条之规定,本局决定责令当事人改正,并处罚如下:1.对未执行产品销售记录制度的行为,给予警告;2.对生产经营未备案化妆品和伪造生产许可证标志的行为,没收违法所得25元,并处罚款10000元;以上罚没款总计10025元,上缴国库。罚款金额（万元）1.000000没收违法所得0.002500暂扣或吊销证照名称及编号-违法行为类型东阳市逸龙化妆品有限公司生产未经注册、备案的化妆品案处罚依据《化妆品监督管理条例》第五十九条　有下列情形之一的,由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品;违法生产经营的化妆品货值金额不足1万元的,并处5万元以上15万元以下罚款;货值金额1万元以上的,并处货值金额15倍以上30倍以下罚款;情节严重的,责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件,10年内不予办理其提出的化妆品备案或者受理其提出的化妆品行政许可申请,对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的3倍以上5倍以下罚款,终身禁止其从事化妆品生产经营活动;构成犯罪的,依法追究刑事责任:(二)生产经营或者进口未经注册的特殊化妆品;;《中华人民共和国工业产品生产许可证管理条例》第四十九条;《化妆品监督管理条例》第六十二条　有下列情形之一的,由负责药品监督管理的部门责令改正,给予警告,并处1万元以上3万元以下罚款;情节严重的,责令停产停业,并处3万元以上5万元以下罚款,对违法单位的法定代表人或者主要负责人、直接负责的主管...违法事实主要违法事实:被处罚人自2024年3月2日开始在国内销售未备案和伪造生产许可证标志的化妆品,另当事人未执行进货查验记录制度。行政处罚种类、依据、内容:当事人生产经营未备案化妆品的行为,违反了《化妆品监督管理条例》第十七条之规定。当事人未执行产品进货查验记录制度的行为,违反了《化妆品监督管理条例》第三十一条之规定。当事人伪造生产许可证标志的行为,违反了《中华人民共和国工业产品生产许可证管理条例》第三十五条之规定。依据《中华人民共和国行政处罚法》第二十八条第一款、第二十九条、《化妆品监督管理条例》第六十一条第一款第一项和《中华人民共和国工业产品生产许可证管理条例》第五十一条之规定,本局决定责令当事人改正,并处罚如下:1.对未执行产品销售记录制度的行为,给予警告;2.对生产经营未备案化妆品和伪造生产许可证标志的行为,没收违法所得25元,并处罚款10000元;以上罚没款总计10025元,上缴国库。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关东阳市市场监督管理局处罚机关统一社会信用代码11330783MB0N94570U数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420

开封市祥符区和谐大药房统一社会信用代码：91410212MA3XB6GM0T行政处罚决定书文号汴祥市监处罚﹝2026﹞29号处罚类别罚款处罚决定日期2026-06-29处罚内容现责令当事人改正违法行为，并建议处罚如下： 罚款叁万元整（￥30000.00）。罚款金额（万元）3.0没收违法所得、没收非法财物的金额（万元）0.0暂扣或吊销证照名称及编号— —违法行为类型220112违法事实经查，当事人柳**2012年开始经营开封市祥符区和谐大药房，营业执照上显示投资人姬**是该店职业药师，实际出资和经营人（投资受益人）是柳**。 2022年11月份至2024年11月份柳**共通过微信号wxid-xp54wuakn5fal2的业务员处购买117890元的药品放在开封市祥符区和谐大药房销售，现已销售完，销售上述药品共获利8000元左右（已上缴到周口市公安局经济开发区分局），违法销售药品货值金额125890元。 上述事实，主要有以下证据证明： 1、周口市川汇区人民检察院不起诉决定书一份，周口市川汇区人民检察院监察意见书一份，证实该案件的来源; 2、现场笔录一份，证实执法人员到涉案药店依法进行现场核查的事实; 3、执法人员亮证照片、现场检查的照片，证实我局执法人员对当事人亮明身份依法办案的事实； 4、询问笔录三份，证实当事人涉嫌未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的事实; 5、营业执照复印件一份、当事人投资人身份证复印件一份、柳**身份证复印件一份，证实当事人主体资格； 6、授权委托书一份，证实当事人委托柳**接受调查的事实； 7、柳**情况说明一份，转账记录二份，证实柳**违法的事实； 8、开封市祥符区城东街道证明一份，医院诊断报告一份，证实柳**经济状况。处罚依据《中华人民共和国药品管理法(2019修订)》处罚机关祥符区市场监督管理局处罚机关统一社会信用代码11410224MB171091X1数据来源河南省市场监督管理局数据来源单位统一社会信用代码11410000MB1912677J备注— —处罚领域市场监管