Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Searah DeysachPresidentEarly to Bed, Inc.5138 North Clark StreetChicago,IL60640United Statessearah@early2bed.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #720822December 16, 2025Dear Searah Deysach:The United States Food and Drug Administration (FDA) has reviewed Early to Bed, Inc.’s (“your firm”) website (early2bed.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.For example, our review of your firm’s website revealed that you are distributing the GenderBender line of binders, which its manufacturer, GenderBender LLC, claims are intended “for wearing after top surgery to keep swelling down” and to cause “gender euphoria” (www.genderbenderllc.com).Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. Section 510 of the Act requires domestic and foreign device establishments to submit annual establishment registration and device listing information to FDA by electronic means during the period beginning October 1st and ending December 31st of each year. Our records indicate that the binders in the GenderBender line were manufactured, prepared, propagated, compounded, or processed in an establishment that was not duly registered and were not included in a list required by section 510 of the Act. Therefore, the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)).The introduction or delivery for introduction into interstate commerce of these misbranded devices is a prohibited act under section 301(a) of the Act, 21 U.S.C. § 331(a).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 720822” 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: info@early2bed.com

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Lim Tong MoiPartnerTOMSCOUT163 Still RoadBoon Court423996Singaporeabuse@tomscout.comIssuing Office:Center for Devices and Radiological HealthUnited StatesUnited StatesWARNING LETTERCMS# 720850December 16, 2025Dear Lim Tong Moi:The United States Food and Drug Administration (FDA) has reviewed TOMSCOUT’s (“your firm”) website (tomscout.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: “High-Performance Bandage Binder”, “All-Day Comfort Binder”, “Swimming Binder Set”) 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: “Binders help reduce gender dysphoria”•Per your firm’s website: "Using a chest binder to flatten the chest can help alleviate gender dysphoria”•Per your firm’s website: "binding alleviates distress associated with 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., “our founder began a two-year redesign journey”, “Designed with care by and for transmasc, non-binary & gender-diverse folks”). 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 720850” 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,/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: hello@tomscout.com

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Marli WashingtonManagerMarli Washington Design, LLC2502 Harford RdBaltimore,MD21218United Stateslegal@gc2b.infoIssuing Office:Center for Devices and Radiological HealthUnited StatesUnited StatesWARNING LETTERCMS #720840December 16, 2025Dear Marli Washington:The United States Food and Drug Administration (FDA) has reviewed Marli Washington Design, LLC d/b/a gc2b’s (“your firm”) website (gc2b.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: “Black Half Binder (Classic 2.0)”, “Black Tank Binder (Classic 2.0)”, “White Half Binder (Classic 2.0)”, “White Tank Binder (Classic 2.0)”, “Nude No. 5 Half Binder (Classic 2.0)”, “2b Luxe White Racerback”, “2b Luxe Black Half”) 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: “our product is aimed at helping to relieve dysphoria for trans folks”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., “Our founder, CEO, and designer . . . .”; “Using his background in Industrial Design and expertise in textiles . . . .”; “The result was the first binder designed and patented specifically for gender-affirming chest binding.”). 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 720840” 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 AdministrationSpotify, Inc.: abuse@spotify.com, abuse@gc2b.co, support@gc2b.co

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Kylo FreemanFounderFor Them, Inc.122 East 42nd St, 18th FloorNew York,NY10168United StatesIssuing Office:Center for Devices and Radiological HealthUnited StatesUnited StatesWARNING LETTERCMS# 720839December 16, 2025Dear Kylo Freeman:The United States Food and Drug Administration (FDA) has reviewed For Them, Inc.’s (“your firm”) website (forthem.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: “Jock Top”, “Binder Max”, “Binder All Day”) 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: “How to manage chest dysphoria & practice safe binding”• Per your firm’s website: “Gender dysphoria sucks…It is kinda like quantitative to chronic pain…Regarding chest dysphoria, binders are a lifesaver. It's very important to use a safe binder rather than ACE bandages or tape because that can cause a lot of problems with anatomy and your ribs…Wear your binder whenever you can.”• Per your firm’s website: “A poorly fitting chest binder can result in gender dysphoria, and even broken ribs—For Them founder Chloe Freeman set out to change this with fantastic results.”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 One Company Designed a CrucialAccessory for the Queer Community: The Binder.”). 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 720839” 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: abuse@forthem.com; team@forthem.com

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Dumesh KankanamalageChief Executive OfficerPhiladelphia 7, Inc d/b/a Passional Boutique317 South StPhiladelphia,PA19147United Statesmanager@passionalboutique.comIssuing Office:Center for Devices and Radiological HealthUnited StatesUnited StatesWARNING LETTERCMS# 720843December 16, 2025Dear Dumesh Kankanamalage:The United States Food and Drug Administration (FDA) has reviewed Philadelphia 7, Inc.’s (“your firm”) website (passionalboutique.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.For example, our review of your firm’s website revealed that you are distributing the UNTAG line of binders, which its manufacturer, Trans-Missie B.V., claims are intended for “helping reduce gender dysphoria” (www.untag.com).Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. Section 510 of the Act requires domestic and foreign device establishments to submit annual establishment registration and device listing information to FDA by electronic means during the period beginning October 1st and ending December 31st of each year. Our records indicate that the binders in the UNTAG line were manufactured, prepared, propagated, compounded, or processed in an establishment that was not duly registered and were not included in a list required by section 510 of the Act. Therefore, the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)).The introduction or delivery for introduction into interstate commerce of these misbranded devices is a prohibited act under section 301(a) of the Act, 21 U.S.C. § 331(a).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 720843” 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: passionalstaff@gmail.com

天津市药品监督管理局关于发布天津市医疗器械监督抽检结果的通告（2025年第1期） 为加强医疗器械监督管理，保障医疗器械产品质量安全有效，天津市药品监督管理局组织对医用防护口罩、血液透析及相关治疗用浓缩物、一次性使用输液器、热敷贴、甲型/乙型流感病毒抗原检测试剂盒等47个品种进行了产品质量监督抽检，有2批次产品不符合标准规定。具体情况通告如下：一、被抽检项目不符合标准规定的医疗器械产品（一）多功能手术解剖器（电凝切割器）：为天津高领科技有限公司生产，涉及ME设备的可用性不符合标准规定。（二）热敷贴：为江苏汉药医疗器械有限公司生产，涉及最高温度不符合标准规定。以上抽检不符合标准规定产品的具体情况见附件。二、监管要求相关药品监管部门已按照《医疗器械监督管理条例》等法规规章要求，对抽检中发现的上述不符合标准规定产品及相关企业依法进行查处，督促其采取风险控制措施、查明产品问题原因、制定并落实整改措施。特此通告。 附件：天津市医疗器械抽检不符合标准规定产品名单                                                              2025年12月18日（此件主动公开）

　　近期，随着冬季流感高发，流感用药需求显著上升，为切实保障药品质量安全，广东省药品监督管理局组织对抗病毒、解热镇痛、祛痰止咳等流感常用药品的部分生产企业开展巡查，重点聚焦流感用药生产质量安全，旨在确保广大人民群众用药安全、有效、可及。 　　巡查过程中，检查人员督促药品生产企业认真落实主体责任，建立完善的质量管理体系，确保药品生产全过程持续符合《药品生产质量管理规范》要求，深入企业生产车间、仓储区域、检验实验室等关键场所，对原料投料、生产过程控制、成品检验及产品放行等核心环节进行了重点检查。 　　除重点关注药品质量安全外，检查人员还查看了流感用药供应情况，详细调阅了库存记录与销售数据，要求企业根据市场实际需求科学制定生产计划，在保障药品质量的前提下，全力确保产能充足、供应及时，切实满足公众用药需求。（省局药品监管一处供稿）

为加强药品质量监管，保障公众用药安全有效，按照《2025年山西省药品监督抽检计划》，山西省药品监督管理局组织对全省药品生产、经营、使用环节进行药品质量抽查检验。现将抽检发现不符合规定的5批次药品信息予以通告（详见附件）。对不符合规定的药品，我省各级药品监督管理部门已要求相关企业和单位采取了必要的风险控制措施，对不符合规定原因开展调查并进行整改，依法对违法行为进行查处。特此通告。附件：1.5批次不符合规定药品名单2.不符合规定项目小知识山西省药品监督管理局2025年12月18日 （主动公开）附件15批次不符合规定药品名单 药品品名标示生产企业规格批号抽样环节检品来源检验依据检验结论不符合规定项目检验单位茯苓河北美康药业有限公司中药饮片241101010使用单位太原市中医医院《中华人民共和国药典》2020版第一增补本不符合规定[检查]水分山西省检验检测中心麸炒山药安国市祁澳中药饮片有限公司中药饮片2306810141经营单位寿阳县滨阳路老百姓大药房有限公司《中华人民共和国药典》2020年版一部不符合规定[性状]晋中市综合检验检测中心浙贝母甘肃省永成制药有限责任公司中药饮片25011301经营单位广灵县同盛老药工大药房有限公司《中华人民共和国药典》2020年版一部不符合规定[性状]大同市综合检验检测中心浙贝母安徽桐花堂中药饮片科技有限公司中药饮片20250402使用单位太原市中医医院《中华人民共和国药典》2020年版一部不符合规定[性状]山西省检验检测中心金银花河北康盛华药业有限公司中药饮片202412001使用单位方山碧秀社区卫生服务站《中华人民共和国药典》2020版四部通则0212不符合规定[检查]（33种禁用农药）氟虫腈吕梁市综合检验检测中心附件2不符合规定项目小知识一、性状项下常记载外观、臭、味、溶解度以及物理常数等，在一定程度上反映药品的质量特性。中药饮片性状项不符合规定，可能涉及药材种属偏差、炮制工艺有瑕疵、储存不当等情形。二、水分系指药品中的含水量。水分偏高或偏低通常与工艺、包装不当以及储运环境等因素有关。三、禁用农药残留量反映的是中药材或饮片中残留的禁用农药的量。

2025年第100号根据《中华人民共和国行政许可法》《中华人民共和国药品管理法》《药品经营和使用质量监督管理办法》等规定，现决定依法注销江西文成医药有限公司的《药品经营许可证》（详见附件）。特此公告。附件：注销药品经营许可证企业名单                       江西省药品监督管理局2025年12月15日附件：注销药品经营许可证企业名单序号企业名称法定代表人许可证编号经营地址注销原因1江西文成医药有限公司袁海林赣AA796000672江西省吉安市吉州区兴桥镇吉兴大道9号华通物流园6幢201-03主动申请注销

各市、沈抚示范区市场监督管理局、各检验检测机构：  为进一步强化检验检测行业事中事后监管，压实机构主体责任，优化营商环境，防范重点领域风险，保障公众健康和社会稳定，强化行业公信力建设，辽宁省市场监督管理局于2025年5月至12月在全省范围内开展了省级资质认定检验检测机构“双随机、一公开”监督检查工作。现将检查结果通报如下：  一、基本情况  本次“双随机、一公开”监督检查坚持依法依规、公平公开的原则，灵活采取三省一区协同、省市联合、交叉互检等检查方式，重点关注机动车检验、食品检验、产品质量、环境监测、建筑材料（含建筑保温材料）、成品油、碳排放等承担重要民生保障职责且潜在风险隐患较多的领域，严厉打击出具虚假、不实检验检测数据和结果等违法违规行为。  2025年省本级抽查50家检验检测机构，其中产品质量检验机构7家、食品检验机构3家、机动车检验机构6家、环境监测机构5家、建筑材料检验机构6家、成品油检验机构3家、碳排放检验机构4家、省级质检中心6家、综合类（含机动车）9家、医药类1家。检查结果：23家机构通过（含自行整改后通过），16家机构责令改正，5家机构移交执法部门进一步查处，6家机构为三省一区互检计划内机构，检查结果由属地局自行公布。  各地市场监管部门联合行业主管部门监督检查686家检验检测机构，具体检查结果由各地实施部门予以公布。  二、存在问题  本年度监督检查发现的主要问题有：  （一）主体责任意识不强  部分机构未按要求开展实质性自查，仅机械填写《2025年度省级资质认定检验检测机构自查表》，未对照其逐项排查风险点。个别机构未制定年度培训计划，或培训内容未覆盖最新法规标准（如《检验检测机构监督管理办法》修订内容），导致人员能力与岗位要求脱节。部分机构负责人对质量管理体系运行不重视，未定期组织内部监督，导致问题长期累积。部分机构利益冲突，未有效规避营业执照经营范围与资质认定附表存在利益冲突（如同时开展“咨询”与“检验检测”业务），且未向监管部门备案或主动整改。  （二）质量管理体系不健全  部分机构体系文件未能根据实际情况及时更新，导致体系要求与实际操作脱节。内部审核和管理评审流于形式，未能深入查找体系运行中存在的问题，审核记录不完整、不规范，缺乏有效的纠正和预防措施。在人员管理方面，部分机构对检测人员的培训考核不到位，人员技术档案不健全。在设备管理方面，仪器设备的维护保养、检定校准不及时，部分关键设备未按规定进行期间核查，设备状态标识混乱，影响检测数据的可靠性。在原始记录方面，存在记录控制不规范、原始记录信息不完整、追溯性差等问题。  （三）检验检测行为不规范  部分机构在检测方法选用上存在偏差，未严格按照标准方法或经确认的非标准方法开展检测，对方法的验证和确认工作不充分，导致检测过程缺乏科学依据。样品管理不规范，样品的采集、运输、存储等环节未能严格遵守相关规定，存在样品混淆、标识不清、保存条件不符合要求等情况，影响检测结果的准确性。此外，部分机构在检测过程中未能有效控制环境条件，如温湿度等关键参数未达到标准要求，且未对环境条件进行持续监控和记录，可能对检测结果的有效性产生影响。  （四）出具虚假报告或超范围检测  个别机构为追求经济利益，无视法律法规底线，存在伪造原始记录、编造检测数据等出具虚假检验检测数据和结果的严重违法违规行为。部分机构在未获得相应检测能力的情况下，擅自承接超出自身技术条件的检测项目，存在超资质认定范围出具报告的情况。  三、下步工作措施  （一）强化整改闭环管理。  针对本次检查中发现的问题，各地市场监管部门要督促指导相关检验检测机构严格按照要求制定详细整改方案，明确整改目标、整改时限和责任人，逐条落实整改措施，确保问题整改到位。对移交执法部门查处的机构，要依法依规严肃处理，及时向社会公开处理结果，形成有效的震慑效应。同时，要建立整改情况“回头看”机制，对整改不力或敷衍整改的机构，增加监管频次，坚决防止问题反弹。（二）压实机构主体责任。  各检验检测机构要切实履行主体责任，将质量管理贯穿于检验检测全流程，定期组织开展内部自查自纠，确保各项管理制度落实落细。加强对从业人员的法律法规和专业技能培训，建立健全人员岗位责任制和考核机制，将责任落实到每个环节、每个岗位，提升全员质量意识和责任意识。完善内部质量监督机制，对检验检测活动进行常态化监督检查，及时发现并纠正存在的问题，保障检验检测数据的真实、准确、可追溯。 （三）引导公众参与监督。  各地市场监管部门应鼓励社会各界通过官方渠道对检验检测机构的违法违规行为进行举报。畅通投诉举报渠道，及时回应公众关切，并依法依规进行调查处理，形成“机构自律、政府监管、社会监督”的多元共治格局，共同推动检验检测行业健康有序发展。   附件：2025年度省级资质认定检验检测机构“双随机、一公开”监督检查结果汇总表