根据《化妆品监督管理条例》《化妆品注册备案管理办法》和《国家药监局关于实施有关事项的公告》（2021年第35号）等有关规定，我局于2025年9月19日发布了《浙江省药品监督管理局关于拟取消未提交2025年度报告普通化妆品备案的公告》（2025年第7号）。公告期内，相关化妆品备案人未对其拟被取消备案产品提出陈述和申辩或经审核申诉未被采纳。根据《化妆品监督管理条例》第十八条、《化妆品注册备案管理办法》第三十七条、第五十九条和《国家药监局关于实施〈化妆品注册备案资料管理规定〉有关事项的公告》（2021年第35号）等规定，现依法对我省未按规定提交2025年度报告，未能证明符合法律法规、强制性国家标准和技术规范情况的普通化妆品（产品清单见附件）予以取消备案。特此通告。附件：1.浙江省未提交年度报告的国产普通化妆品清单2.浙江省未提交年度报告的进口普通化妆品清单浙江省药品监督管理局2025年12月17日

南京易乐医疗器械有限公司报告，由于产品植入眼内后，出现不明原因的浑浊影响医生观察眼底的情况，南京易乐医疗器械有限公司作为进口代理人，对法国爱克眼科有限公司生产的眼科手术用硅油主动召回。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》。

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监武药处罚〔2025〕24号武汉奇运佳医药有限公司杜全91420105303646028D销售劣药当事人销售劣药托西酸舒他西林胶囊(批号： 2406801)的行为，违反了《中华人民共和国药品管理法》第九十八条第一款的规定没收违法所得《中华人民共和国药品管理法实施条例》第七十五条的规定主动履行2025年12月8日湖北省药品监督管理局2025年12月4日

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Anthony GuajardoDirectorTG Supply LLC d/b/a TransGuy Supply(b)(4)United Statesabuse@transguysupply.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #720846December 16, 2025Dear Anthony Guajardo:The United States Food and Drug Administration (FDA) has reviewed TG Supply LLC d/b/a TransGuy Supply’s (“your firm”) website (transguysupply.com) and observed that your website offers various breast binders for sale. 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.Our review of your firm’s website revealed statements that these breast binders (example trade names: “Long Tank Chest Binder – Maximum Compression”, “TGS Short Racerback Chest Binder – Maximum Compression”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:•Per your firm’s website: “Every product in our binding collection is tested and trusted by our community, vetted for chest safety, dysphoria relief, and quality construction”•Per your firm’s website: “Why People Bind: To reduce gender dysphoria and feel more at home in their body.”Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “We design and source gear for real bodies.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.Therefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).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 and injunction. 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 CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 720846” when replying.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. 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 yours,/s/Michael J. HoffmannDirectorOffice of Health Technology 3 - Gastrorenal, ObGyn,General Hospital, and Urology DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthFood and Drug Administrationcc: Shopify, Inc.abuse@shopify.com

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Yan NieDirectorFlux Lab Pte. Ltd. d/b/a The Fluxion60 Paya Lebar Road #12-03Paya Lebar Square409051Singaporesupport@thefluxion.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #720847December 16, 2025Dear Yan Nie:The United States Food and Drug Administration (FDA) has reviewed Flux Lab Pte. Ltd. d/b/a The Fluxion’s (“your firm”) website (thefluxion.com) and observed that your website offers various breast binders for sale. 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.Our review of your firm’s website revealed statements that these breast binders (example trade names: “The Fluxion Tank Chest Binder – Black”, “The Fluxion Regular Chest Binder-Half-Black”, “The Fluxion GYM Chest Binder – Racerback Taupe”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:Per your firm’s website: “Chest Binders: In contrast, chest binders are used primarily by transgender individuals and those with gender dysphoria to compress and flatten the chest.”Per your firm’s website: “Binding can be a significant step in affirming one’s gender and can help alleviate gender dysphoria.”Per your firm’s website: “Freedom from Chest Dysphoria: Those who seek a secure, snug fit without the discomfort of breast pressure to alleviate chest dysphoria and promote overall well-being”Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “That’s why we incorporate our expertise in developing compression products from the sports and medical industries into our product development process.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.Therefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).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 and injunction.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, 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. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. 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 CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720847” when replying.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.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 yours,/S/Michael J. HoffmannDirectorOffice of Health Technology 3 - Gastrorenal, ObGyn,General Hospital, and Urology DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthFood and Drug Administration

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Xandar ShephardManagerGenderBender LLC21042 S Main StCarson,CA90745United Statesgenderbenderapparel@gmail.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #720842December 16, 2025Dear Xandar Shephard:The United States Food and Drug Administration (FDA) has reviewed GenderBender LLC’s (“your firm”) website (genderbenderllc.com) and observed that your website offers various breast binders for sale. 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.Our review of your firm’s website revealed statements that these breast binders (example trade names: “Half Length Soft Binder with Zipper”, “Half Length Soft Binder”, “Full Length Soft Binder”, “3/4 Length Soft Zip Binder for Large Cup Sizes, “Swimsafe Rigid Binder and Attachable Swim Tank”, “Swimsafe 3/4-Length Deluxe Semi-Rigid Binder”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:Per your firm’s website: “Chest binding is the practice of compressing breast mass into a more masculine shape, often done in the LGBTQ community for gender euphoria…but also practiced by cis men with gynecomastia.”Per your firm’s website: “Our compression wraps are perfect for wearing after top surgery to keep swelling down without needing to lift your arms.”Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “These soft bands of high quality elastic are premade in sizes XS-4X, or we can custom-make larger sizes.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.Therefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).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 and injunction.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 CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720842” when replying.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.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.

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Eli Coughlin-GalbraithOwnerShapeShifter Apparel, LLC130 Austine DrBrattleboro,VT05301United Statesinfo@shapeshifters.coIssuing Office:Center for Devices and Radiological HealthUnited StatesUnited StatesWARNING LETTERCMS #720845December 16, 2025Dear Eli Coughlin-Galbraith: The United States Food and Drug Administration (FDA) has reviewed Shapeshifters Apparel LLC’s (“your firm”) website (shapeshifters.co) and observed that your website offers various breast binders for sale. 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.Our review of your firm’s website revealed statements that these breast binders (example trade names: “Island Time Binders”, “Custom Print Binders”, “Skin Tone Binders”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:•Per your firm’s website: “Chest Binding 101… What Sorta Reasons? Gender dysphoria.”•Per your firm’s website: “The right amount of compression is the amount that feels good (dysphoria)”•Per your firm’s website: “The "right" amount of compression can vary from person to person, depending on chest size, chest tissue density, physical activity level, dysphoria level, lung capacity, affinity for the sensation, and more.”Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “Custom-sized, hand-made, made-to-order.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.Therefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).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 and injunction. 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 CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720845” when replying.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. 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 yours,/s/Michael J. HoffmannDirectorOffice of Health Technology 3 - Gastrorenal, ObGyn,General Hospital, and Urology DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthFood and Drug Administrationcc: Shopify, Inc.abuse@shopify.com

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Fran DunawayPresidentTomboyX, PBC2200 Western AvenueSeattle,WA98121United Stateslegal@tomboyx.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #720849December 16, 2025Dear Fran Dunaway:The United States Food and Drug Administration (FDA) has reviewed TomboyX, PBC’s (“your firm”) website (tomboyx.com) and observed that your website offers various breast binders for sale. 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.Our review of your firm’s website revealed statements that these breast binders (example trade names: “Compression Top - Black”, “Racerback Compression Top - Chai”, “V Neck Compression Top - White”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:Per your firm’s website: “Many individuals who identify as transgender, non-binary, or gender-fluid utilize chest binding as a way to help manage their own dysphoria”Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “We pay obsessive attention to every design aspect, leaving no detail overlooked so that our community can live and experience a life unbound.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.Therefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).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 and injunction.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 CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720849” when replying.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. 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 yours,/S/Michael J. HoffmannDirectorOffice of Health Technology 3 - Gastrorenal, ObGyn,General Hospital, and Urology DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthFood and Drug Administration

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Christopher RhodesManagerFLAVNT Streetwear, LLC(b)(4)United Statesabuse@flavnt.comIssuing Office:Center for Devices and Radiological HealthUnited StatesUnited StatesWARNING LETTERCMS #720838December 16, 2025Dear Christopher Rhodes: The United States Food and Drug Administration (FDA) has reviewed FLAVNT Streetwear, LLC’s (“your firm”) website (flavnt.com) and observed that your website offers various breast binders for sale. 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.Our review of your firm’s website revealed statements that these breast binders (example trade names: “Birch Bareskin 2.0”, “Bone Bareskin 2.0”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:• Per your firm’s website: “Chest binding should never be harmful — yet we still see people getting injured from unsafe or poorly designed binders. We engineered our design to offer moderate compression, enough to help with gender dysphoria without cutting off your airflow or bruising your torso.”• Per your firm’s website: “Just about 5 years ago we were prepping to launch a Kickstarter campaign for our Bareskin Binder: a masculine swim top/binder option for folx who didn’t have the perfect dysphoria-easing solution”• Per your firm’s website: “Chest binding is the act of compressing breast tissue to create a flatter chest appearance. Many transmasc, nonbinary, and gender-nonconforming people bind as part of their gender expression or to ease gender dysphoria.”Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “How we created a binder that disrupted the binder market forever.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.Therefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).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 and injunction. 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 CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720838” when replying.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. 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 yours,/S/Michael J. HoffmannDirectorOffice of Health Technology 3 - Gastrorenal, ObGyn,General Hospital, and Urology DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthFood and Drug Administrationcc: Shopify, Inc.abuse@shopify.comcc: yourpals@flavnt.com

企业名称辽宁益心医药连锁有限公司企业类型药品零售连锁总部检查时间2025年9月22日-2025年9月28日2025年12月12日-2025年12月12日所在地市鞍山市检查依据《药品管理法》《药品管理法实施条例》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律、法规、规范性文件。检查事项药品经营检查检查方式常规检查；专项检查检查内容1.执行GSP情况；2.药品“清源”行动专项检查。存在问题在收货与验收方面存在个别冷链药品运输记录不全的问题；在质量管理体系文件方面存在未根据验证报告修改相应操作规程的问题。处理措施责令限期整改整改情况已按要求完成整改序号2企业名称海城柳乾医药连锁有限公司企业类型药品零售连锁总部检查时间2025年9月8日-2025年9月10日2025年12月8日-2025年12月8日所在地市鞍山市检查依据《药品管理法》《药品管理法实施条例》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律、法规、规范性文件。检查事项药品经营检查检查方式常规检查；专项检查检查内容1.执行GSP情况；2.药品“清源”行动专项检查。存在问题在质量管理体系文件方面存在企业制定的质量管理体系文件不符合企业经营实际的问题；在校准和验证方面企业未根据验证确定的参数合理使用保温箱的问题；在收货与验收方面存在冷链药品运输记录及中药饮片验收记录内容不全的问题；在销售方面存在个别药品未出库复核的问题。处理措施责令限期整改整改情况已按要求完成整改